IT Systems Validation

GMP guidelines require that IT systems must be validated by adequate and documented testing. It is required in all regulated industries: pharmaceuticals, medical devices, food and beverages, cosmetics.

GMP Requirements - “The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes."

Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. This is the formal testing to demonstrate that the software meets its specified requirements.

This is a documented process to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner, that it will produce information or data that meets a set of defined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended.

Validation helps to ensure that both new and existing computer systems consistently fulfill their intended purpose and produce accurate and reliable results that enable regulatory compliance, fulfillment of user requirements, and the ability to discern invalid and/or altered records.

Computer systems need to be examined to confirm that the systems will work in all situations.

Computer system validation is required when configuring a new system or making a change in a validated system (upgrades, patches, extensions, etc.).

Validation processes should be based on applicable regulations and guidance, best practices for the domain, and the characteristics of the system being validated.

To validate software, it must be:

• structured, documented, and evaluated as it is developed;
• checked to make sure that it meets specifications;
• adequately tested with the assigned hardware systems;
• operated under varied conditions by the intended operators or persons of like training to assure that it will perform consistently and correctly.

Why Do We Need IT Systems Validation?

Regulated industries have to adopt many compliance procedures to make sure their final product is safe for distribution or sale.

Regulatory agencies around the world require validation processes to confirm the accuracy and integrity of data in computerized systems in order to ensure product safety and effectiveness.

The process is used to make sure that the IT systems are completely transparent, robust and tamper proof because they directly impact public health and safety.

It is critical that these systems can be relied upon to produce data consistently and store those electronic data records so that they stand the test of time.

Validation is one of those compliance requirements and is part of the Quality Management System within regulated industries.

There are several of examples as to why software validation is important. We can look at our library of FDA Warning Letters to see more than 200 reasons to validate your software or systems.

There is a case study about Therac-25, a radiation therapy machine from the 1980s.

Due to programming issues, the machine could administer the wrong amount of radiation to patients (often as a huge overdose), which led to serious injuries and even death. Had there been software validation standards in place, these types of instances could have been identified and remediated prior to the treatment of patients.

Computer systems validation is serious and the FDA and other regulatory agencies do not take this lightly.

What benefits does validation deliver?

• Accuracy – when test outcomes are routinely checked against predetermined expected results, the accuracy of computer systems within the manufacturing process can be relied upon.
• Security – validation processes make clear when entries to the system have been altered.Reliability – the process ensures that system outputs can be relied upon throughout the life cycle.
• Consistency – it also ensures that the system output is consistent across its life cycle.
• Optimization – following the process also means that computer systems can be more easily optimized. Optimization is a key feature of an effective and efficient manufacturing site.

When used as intended, systems validation can provide increased process reliability, confidence, improved production results, and reduced operating expenses significantly.

Purpose of Document Control and its Role in Quality Assurance

GxP/GMP, GDocP, ISO 9000 and documentation

GxP stands for "Good Practice" which is quality guidelines and regulations. The "x" stands for the various fields, for example Good Documentation Practice or GDocP, Good Financial Practice or GFP and so on. There are many instances of these regulations. One instance of GxP is Good Manufacturing practice or GMP.

GMP describes required Quality Management System (QMS) for manufacturing, testing, and quality assurance in order to ensure that products are safe, pure, and effective. GMP has ultimate goal to enable companies to minimize or eliminate contamination and errors which protects consumers from purchasing a product which is not effective or even dangerous. GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics.

GMP documentation requirements are aligned with Good Documentation Practice (GDocP). GDocP is the standard in the regulated industries by which documents are created and maintained. It is the systematic set of procedures of preparation, reviewing, approving, issuing, recording, storing, and archiving documents.

The ISO 9000 is a set of standards which deals with fundamentals of Quality Management System (QMS) that helps organizations to ensure that they meet customers’ needs within statutory and regulatory requirements related to a product or service. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfil.

GxP/GMP, GDocP, ISO 9000 are about QMS where an organization needs to demonstrate its ability to consistently provide a product that meets customer and applicable statutory and regulatory requirements.

Documentation is the key to compliance with these regulations and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. GMP, GDocP, and ISO 9000 are enforced by regulatory agencies. Auditors pay particular attention to documentation to make sure that it complies with these regulations.

Therefore, in order for an organization to meet these requirements, it must have documentation procedures in place. Documentation is a critical tool for ensuring this compliance.

Purpose of document control and its role in Quality Assurance (QA)

The primary purpose of document control is to ensure that only current documents and not documents that have been superseded are used to perform work and that obsolete versions are removed. Document control also ensures that current documents are approved by the competent and responsible for the specific job people and documents are distributed to the places where they are used.

Document control is an essential preventive measure ensuring that only approved, current documents are used throughout an organization. Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, customer satisfaction, and can even cause death.

The role of QA, in regards to the document control system is one of management and overview.

QA ensures that all documents are maintained in a controlled fashion and that all controlled documents are approved by the appropriate subject matter experts, are consistent with other documents, and are the most current version.

One way that QA ensures this is by being the last signature on all approved documents. All documents - current, obsolete, superseded, as well as all the history on the creation and revision of the document should be kept in Quality Assurance.

Headless CMS - Contentful

In the last post, we have described headless CMS. Headless CMS architecture is rising in popularity in the development world. 

This model allows breakthrough user experiences, gives developers the great flexibility to innovate, and helps site owners future-proof their builds by allowing them to refresh the design without re-implementing the whole CMS.

One of headless CMS is Contentful. Contentful platform lets you create, manage and distribute content to any platform. It gives you total freedom to create your own content model so you can decide which content you want to manage. 

With an uncluttered user interface, Contentful is an efficient tool for creating and managing your content online, either alone or in team. You can assign custom roles and permissions to team members, add validations depending on the kind of content you have to insert and add media such as images, documents, sounds or video.

Contentful has a three-step process. First, you define a content model which is independent from any presentation layer that defines what kind of content you want to manage. In a second step, you and other internal or external editors can manage all of the content in easy-to-use and interactive editing interface. In the third step, the content is served in a presentation-independent way.

Being presentation-layer agnostic is one of the strengths of Contentful because you will be able to reuse your content across any platform.

To create a web site, you will either have to code it yourself and load content from Contentful API or work with someone who can develop the web site for you. Contentful is the platform where you can update the content of your web site, a mobile app or any other platform that displays content.

Contentful runs on all browsers. Contentful offers the most powerful REST APIs and the only enterprise-grade in-production GraphQL API.

There are three steps you'll have to take in order to deliver content from Contentful to your apps and websites.

1. Create your Content Model

The Content Model is the first step to structuring your content properly. It consists of creating content types that will accept only certain types of data for entry. For example, when creating an interactive quiz, you will need to add something that is a question, multiple answers, an indicator of the correct answer and potentially an image. This can be set up in the content model, so you can then easily just add as many "Questions" to your Quiz as you want.

2. Add Entries and Assets

Entries refer to the content itself. Entries could be blog posts, product features or ingredients of a recipe or any other content. These entries will depend on your previously created content model. In this phase you can also add assets like images, sounds, videos and many other files.

3. Deliver your content with our API

The delivery part of the content may or may not be left only to developers. In this step you set up API Keys that will determine which content will go to which platform. After the delivery is set up correctly, your content is then available for consumption as soon as you hit the “Publish” button.

We have over 18 years experience with numerous CMS, so we can help you with Contentful as well. Call us today for a free, no obligation consultation.

Headless CMS vs Decoupled CMS

A headless content management system, or headless CMS, is a back-end only content management system (CMS) built as a content repository that makes content accessible via a RESTful API for display on any device.

The term “headless” comes from the concept of chopping the “head” which is the front end, i.e. the web site off the “body” (the back end, i.e. the content repository).

Whereas a traditional CMS typically combines the content and presentation layers of a web site, a headless CMS is just the content component which focuses entirely on the administrative interface for content creators, the facilitation of content workflows and collaboration, and the organization of content into taxonomies.

It doesn’t include presentation layers, templates, site structure, or design, but rather stores its content in pure format and provides access to other components (e.g. delivery front ends, analytics tools, etc.) through stateless or loosely coupled APIs.

The headless CMS concept is one born of the demands of the digital era and a business’s need to focus on engaging customers with personalized content via multiple channels at all stages of the customer journey. As the content in a headless CMS is considered “pure” (because it has no presentation layer attached) just one instance of it can be used for display on any device; web site, mobile, tablet, smart watches, etc.

There is some confusion around what makes a headless CMS truly “headless”, as vendors use the term somewhat loosely to label their decoupled or hybrid CMS systems. But a true headless CMS is one that was built from the ground up to be API-first, not a full monolith CMS with APIs attached afterwards.

Cloud-first headless CMSs are those that were also built with a multi-tenant cloud model at their core and whose vendor promotes Software as a Service (Saas), promising high availability, scalability, and full management of security, upgrades, and hot fixes, etc. on behalf of clients.

Coupled CMS vs. Headless CMS

Most traditional (monolithic) CMS systems are “coupled”, meaning that the content management application (CMA) and the content delivery application (CDA) come together in a single application, making back-end user tools, content editing and taxonomy, web site design, and templates inseparable.

Coupled systems are useful for blogs and basic web sites as everything can be managed in one place. But this means that the CMS code is tightly connected to any custom code and templates, which means developers have to spend more time on installations, customization, upgrades, hot fixes, etc. and they cannot easily move their code to another CMS.

There is a lot of confusion around the differences between a decoupled CMS and a headless one because they have a lot in common.

A decoupled CMS separates the CMA and CDA environments, typically with content being created behind the firewall and then being synchronized and pushed to the delivery environment.

The main difference between a decoupled CMS and a headless CMS is that the decoupled architecture is active. It prepares content for presentation and then pushes it into the delivery environment, whereas a headless CMS is reactive. It sits idly until a request is sent for content.

Decoupled architecture allows for easier scalability and provides better security than coupled architecture, but it does not provide the same support for omni-channel delivery. Plus, there are multiple environments to manage, this increasing infrastructure and maintenance costs.

Advantages of Headless CMS

• Omnichannel readiness: the content created in a headless CMS is “pure” and can be re-purposed across multiple channels, including web site, mobile applications, digital assistant, virtual reality, smart watches, etc., in other words, anywhere and at any time through the customer journey.
• Low operating costs: headless CMSs are usually cheaper to install and run than their monolith counterparts, especially as they are typically built on a cloud model where multi-tenant options keep the running costs low.
• Reduces time to market: a headless CMS promotes an agile way of working because content creators and developers can work simultaneously, and projects can be finished faster.
• Easy to use: traditional CMSs tend to be cumbersome and complex as vendors attempt to offer every available feature in one box. Headless systems focus on content management, keeping things simple for those who use it on a daily basis. The entire user experience can usually be managed from within one back end.
• Flexibility: content editors can work in whichever headless CMS they like and developers can build any kind of front end they want in their preferred language (e.g. Ruby, PHP, Java, or Swift) and then simply integrate the two via APIs (like JSON or XML) over RESTful communication. This allows for polyglot programming where multiple programming paradigms can be used to deliver content to multiple channels, and enables a company to benefit from the latest developments in language frameworks, promoting a micro-services architecture.
• Cloud Scalability: the content purity and stateless APIs of headless CMSs enable high scalability, especially as the architecture fully leverages the elasticity of a cloud platform.
• System Security: since the content is typically provided through a high-performance Content Delivery Network (rather than directly from the database), the risk of distributed denial-of-service attacks (DDOS) is reduced.
• Marketing empowerment: marketers may end up relying more on developers in certain scenarios, e.g. creating a landing page with custom layout.

Disadvantages of Headless CMS

• Multiple services: managing multiple systems can be challenging and a team’s knowledge base must cover them all.
• No channel-specific support: since pure headless CMSs don’t deal with the presentation layer, developers may have to create some functionality, such as web site navigation.
• Content organization: as pure headless CMSs do not typically provide the concept of pages and web site maps, content editors need to adapt to the fact that content is organized in its pure form, independently on the web site or other channel.

Headless CMS architecture is rising in popularity in the development world. This model allows breakthrough user experiences, gives developers the great flexibility to innovate, and helps site owners future-proof their builds by allowing them to refresh the design without re-implementing the whole CMS.

In the following posts, we will look more into headless CMS and will describe specific headless CMS. Stay tuned.

Knowledge Management Maturity

Regardless of how great its knowledge management, every organization should take time to see if it enables the flow of knowledge across people and systems and identify opportunities for its improvement. 

Most organizations go through some evaluation when they first initiate their KM programs. However, it is equally important to revisit that self-evaluation at key intervals, such as when participation in KM tools and approaches lags or when leaders want to capitalize on the success of an effective, but limited, KM implementation by expanding it organization-wide.

This post is about knowledge management strategy as well as governance, processes, technology, and change management associated with successful and sustainable knowledge management implementation. In following posts, we will share details about the governance structures, processes, technologies, change management enablers and measurement approaches associated with successful and sustainable KM implementations.

Focus on Value Creation

Start with a focus on value creation. When it comes to building KM capabilities within your organization, it’s important to focus on the organization's goals from the very beginning. According to analysis of the assessment data, organizations that acknowledge value creation as a major objective of KM have a significant advantage in setting clear goals and objectives for their KM efforts. 

Specifically, those organizations are nearly four times more likely to document their KM strategies and road-maps than similar organizations which are not focused on value creation and they are 15 times more likely to articulate formal business cases that lay out the expected benefits and impact of applying KM to business opportunities.

Organizations which start by understanding the relationship between the flow of knowledge and desired business outcomes and then work to design KM tools and approaches that will aid those outcomes are successful in their KM efforts.

Any KM initiative worth pursuing must generate business value in the form of increased revenue, faster cycle times, cost savings, enhanced quality or other tangible benefits. When value creation is acknowledged as the underlying goal of KM, the initiative is starting on the right foot.

By contrast, if an organization has not made the connection between KM and value creation is prone to start throwing tools and techniques at employees without thinking through how they will be used or what broader purpose they will serve. And that kind of KM program tends to fade out over time as users fail to perceive why they are being asked to share their knowledge or how the new tools will help them in their day-to-day work.

Define your strategy and road-map

Once your organization recognizes the relationship between KM and business value, the next step is to cement that relationship by building it into a formal KM strategy and road-map. Writing down exactly where your KM program is headed and how you intend to get there is very important. 

A solid strategy will accelerate knowledge management maturity by providing focus, alignment, and credibility throughout your KM journey. It will also guide conversations with the business stakeholders whose support and buy-in you need to win along the way.

Alignment between KM and enterprise strategy is important for many reasons, but most importantly because it helps you justify the ongoing time, energy, and money required to support and participate in KM tools and approaches. If senior leaders understand the link between KM and the big-picture business concerns that keep them up at night, securing support becomes much easier, even during downturns and business disruptions when funding for “nice to have” programs dries up.

Documenting a KM strategy and road-map is linked with an even more meaningful outcome: the ability to leverage knowledge assets for competitive advantage. Almost every modern organization wants to compete on knowledge: to put its collective know-how to work to get to market faster, deliver superior products and services and earn customer loyalty.

KM exhibits its benefits behind the scenes, and customers reap the rewards without distinguishing the role played by better, faster access to institutional knowledge. But regardless of whether customers see your superior KM processes or they just know they’re getting something better from you than from your rivals, the ability to leverage knowledge for competitive advantage is a goal worth striving for.

Estimate impact

The most powerful accelerator of KM maturity related to strategy development involves analyzing the financial and other benefits your organization can expect from implementing the proposed KM tools and approaches. 

Although that may entail estimating a hard-dollar return on initial KM investments, it does not have to. But regardless of the nature of the benefits on which an organization focuses, your KM team must get specific about the projected impact (on productivity, quality, safety or other key performance indicators) and articulate a set of measures that can be tracked to compare reality against the forecast.

Those organizations that follow this strategy, get it back in the form of reliable funding, leadership and business unit support, program resilience and return on investment.

Financial analysis and documentation of benefits would greatly help the allocation of a KM budget. Even more impressively, organizations that document KM benefits are over five times more likely to procure flexible KM budgets that expand in response to increased demand for knowledge assets and competencies. This relationship is logical because leaders tend to be forthcoming with additional capital as needed if they feel confident that their funds will yield tangible results.

A clearly articulated business case and projection of value are also instrumental in engaging and retaining business unit support. There is no more crucial enabler of KM sustainability than solid business unit backing. Your KM core team can only accomplish so much on its own, and without the business dedicating resources and assigning people to support KM processes and approaches, KM’s scope is destined to remain limited.

Solid business unit support goes hand in hand with opportunities to expand and enhance the KM program, so it is not surprising that financial analysis and documentation of benefits are statistically linked to outcomes. 

For example, KM groups that perform the analysis are more likely to enhance KM capabilities across business units or disciplines and to expand focus from initial areas to other areas of the business. They are also more likely to be able to develop a formal business case for expanding KM to new domains based on predicted gains and impact to the organization.

The most compelling reason to perform financial analysis and documentation of benefits is its strong link to return on investment (ROI). Although many KM programs achieve success without measuring ROI, those that rely purely on anecdotal evidence and success stories to justify KM investments may find themselves on shaky ground if the business environment changes or a more skeptical CEO arrives. Some clear measure of business impact, whether ROI or another outcome in keeping with the goals laid out in the KM strategy and road-map is required to ensure sustainable KM development over the long term.

Conducting financial analysis and documentation of benefits during KM strategy development is highly correlated with an ability to show that type of tangible result. KM programs reap what they sow, and those that establish clear milestones and measures of success upfront are much better positioned to substantiate claims of value down the road.

Stay tuned for further posts on knowledge management.

Knowledge Management for a Contact Center

Knowledge management has been helping many organization to achieve higher efficiency and productivity for many years. It is especially important in a contact center.

When a customer calls, contact center agents rely heavily on knowledge base to answer customer questions. Not having knowledge management in place can jeopardize the quality of customer service in a contact center.

The biggest hurdles to providing high quality customer service is lack of contact center knowledge and inconsistency of answers across different channels of contact as well as inability of self-service help center to deliver information needed by customers. The solution to these hurdles is is the unified multiple channels knowledge management.

These are the main reasons why knowledge management is crucial component in service organizations:

1. Multiple Contact Channels – customers contact with organizations using multiple channels. It is very important to provide a single source of the truth, so that contact center

employees can provide consistent answers to customer questions across phone, email, chat, SMS, and social media. Having a central knowledge base accessible across channels

eliminates silos of information that can lead to different answers for the same question.

2. Self-Service – majority of customers prefer to find answers to questions on their own. Since there is no employee involved in this process to provide answers, an easy-to-navigate knowledge base is essential to give customers a place to search for answers on their computers or mobile devices. This can also service customers while employees are on holidays break, sick days, etc. Self-service also deflects need for customers calls, chat and emails.

3. Issue Complexity – one side effect of the popularity of self-service is that the issues that do arrive in the contact center can be the most difficult and complex. Because of this, agents are unlikely to know the answers and will rely heavily on a knowledge base to find information. A good knowledge base which contains information across a wide variety of topics would be very helpful.

Even if an agent has never taken a certain type of call, he/she can resolve the issue with confidence having such knowledge base handy. Ability to answer complex customers' questions would reduce the rate of return due to inability of agents to answer customers' questions and solve their problems.

4. Trusted Content – social content from forums and online communities can be a plentiful source of useful information, but customers can never be sure if the information is accurate. By promoting social content as part of a structured knowledge base, you can ensure that customers trust that the information is accurate and up to date.

5. Tools and Tactics – the tools and tactics to make contact center workforce successful must also evolve. Contact center workforce should be able to look up information rather than memorizing, and they usually rely heavily on a knowledge base to find answers for customers.

6. Pace of Change – when issues arise, up-to-date information is paramount. Weather issues, communication outages and software bugs can all generate an influx of calls demanding answers with the very latest information. A knowledge base gives employees a place to find the most current information on a frequently changing situation.

7. Speed of Answer – everyone is looking for shorter handling time. Customers are happy to get answers quickly, and organizations get the cost savings they require. However,

shorter handling times are only valuable when the call is still resolved with complete, accurate information. A knowledge base provides a quick way to get reliable answers to even the most complex questions.

8. Any Agent, Any Call – specialized agents can cause frustration and inefficiency as customers get transferred from employee to employee to get an answer. When each agent can access the full breadth of information in a central knowledge base, there is less need to specialize agents for tier one calls. Transfers can be reduced, resulting in happier customers and a more efficient contact center.

9. Employees Engagement – it is important to provide the tools for employees to feel engaged, do their jobs well, and feel confident and motivated in their work. A comprehensive knowledge base is a very useful tool that empowers employees and enables them to answer a broad range of customer questions, even on topics they may not have encountered before.

10. Employees Turnover – employees turnover can be extremely costly. Each time a new employee is on-boarded, weeks of time are spent training him/her on the vast array of information required to help customers. A knowledge base that contains the information needed to answer customer questions can significantly reduce training time, allowing trainers to focus on soft skills and customer engagement.

11. Employees Training - you can reduce employees training needs without compromising service quality by having an optimal knowledge base in place. You can also reduce employees training time which in turn cuts the time lost due to training time.

Providing high level of customer service is not easy, but with a successful knowledge management, you can empower your customers and employees with the information they need, when they need it. Since customer service issues will only grow in both number and complexity, now is the time to ensure your customer service operation is equipped with a knowledge management system. Done right, knowledge management can transform contact centers.

Galaxy Consulting has over 18 years experience in knowledge management. Please contact us today for a free consultation.

Taxonomy Development, Management, and Governance

Taxonomies do not exist in isolation. They exist within the context of multiple business processes. Taxonomies can take many different forms and they serve a wide variety of purposes in different organizations. 

A customer-facing search and browse taxonomy that describes a product catalog is a typical application for an e-commerce company while a taxonomy could provide a detailed profile of a scientific domain for indexing research content for a company focused on research and development. Website navigation, customer and employee profiling, inventory management, records management, writing, publishing and content management and site search are other possible taxonomy applications.

Efficient taxonomy management is the best facilitated by formally designating team members’ level of participation and responsibilities. Taxonomy management covers a broad range of activities and the most efficient use of team resources is achieved when responsibilities are clearly defined.

Taxonomy operations are typically performed by personnel with specialized training in library science or information management. The task of taxonomy governance are performed by taxonomy administrators. It is important to develop taxonomy change management procedures when taxonomy is being developed.

A well-governed taxonomy requires a time commitment from stakeholders. Participation in governance team activities is one manifestation of this but of greater significance is the impact that policies and procedures developed by the governance team have on stakeholders and business processes.

The size and precise makeup of taxonomy governance teams vary greatly depending on the size and complexity of both the organization and the taxonomy implementation. At one end of the spectrum a governance team might consist of a few individuals. In contrast, in an enterprise environment taxonomy governance might be one part of a larger data or IT governance organization made up of multiple teams.

It is also worth emphasizing that size is only one factor to consider when devising governance policies and allocating governance resources. For example, regulatory requirements vary widely across industries. It is completely appropriate for a business operating in a highly-regulated industry to dedicate a relatively higher proportion of resources to governance activities.

Governance efforts are more likely to fail because of human factors than technological ones. This means that a realistic assessment of organizational context is an important first step when creating a taxonomy governance team and setting expectations for taxonomy efforts. 

For example, significant disruptions to existing workflows typically result in poor compliance with governance policies. Identifying these potential pitfalls in advance is best accomplished by soliciting input from users at all levels of an organization. This is just one reason why the governance team must include representatives from all stakeholder groups, not just from leadership and project management.

In broad terms representatives from management and business groups, information technology, taxonomy management and taxonomy users come together on the governance team to serve as advocates for their respective groups.

Because of the wide range of potential applications, taxonomy management can be the responsibility of an equally wide range of groups. Information technology groups, user experience and web design groups, libraries, and a range of marketing and business groups are all potential homes for taxonomy management. A taxonomy governance team needs executive sponsors and management representatives who can provide high-level guidance and steer taxonomy efforts in a productive direction for the business as a whole.

All members of the taxonomy governance team should contribute to the creation of a high-level strategy but this is a task for executive sponsors and business decision makers.

Following are some of the important questions to answer during taxonomy development. Taxonomy implementation will be very different depending on the answer to these questions:

• Given that most large organizations have multiple applications that use taxonomies, will a single, multipurpose enterprise taxonomy be created and maintained or will multiple specialized taxonomies be used?
• How will different taxonomy applications be prioritized? Given multiple taxonomy users, how will resources be allocated and how will taxonomy projects be funded?
• Will there be a central taxonomy management group?
• How will taxonomy goals be defined and what metrics will be used to measure success?
• How will new and emerging technologies and trends be evaluated and potentially incorporated?  

A taxonomy deployment impacts many different groups within an organization, which means that conflicts over priorities and resource allocation are not unusual. Awareness of potential conflicts and a transparent decision-making process helps to minimize the strife between stakeholders. Managing the relationships between stakeholders is the single most important task of leadership representatives on the governance team. Leadership representatives on the governance team should include both executive sponsors and business group personnel who can provide insight into business processes and business needs.

Technical support is crucial for successful taxonomy implementation and use. Strategic and business goals must be realistic given an organization’s technical capabilities and constraints. The primary role of taxonomy governance team representatives from technology implementation and support groups is to provide the expertise needed to ensure that business goals align with technical reality.

Taxonomy implementations range from a small number of terms applied through a web publishing platform and managed in a spreadsheet to highly specialized taxonomies consisting of thousands of terms and relationships that are managed with dedicated software and support dozens of consuming systems.

Obviously, the specific details have a significant effect on technical requirements. Many taxonomy management systems provide tools for workflow and governance modeling and enforcement. Alternatively, if the taxonomy is maintained and applied from within a content management system, then the governance team should determine an appropriate level of control and develop mechanisms to implement it.

It is important not to underestimate the work needed to integrate taxonomy management with consuming systems. The reality is that most organizations have a mix of consuming systems. Development resources are required in all of these scenarios and input from technical stakeholders is needed when planning and prioritizing implementation and ongoing maintenance. At the beginning of a taxonomy implementation, technology questions should be on defining technical solutions based on business objectives.

Some of the questions technical stakeholders help to answer include:

• Adapting existing processes and technology versus building or buying new ones.
• In-house development of taxonomy management tools versus purchase of third-party tools.
• Integration requirements for taxonomy management with consuming systems.

As a taxonomy implementation matures, the technical emphasis shifts from implementation to ongoing maintenance and support, as is typical in the software life cycle.

Technology stakeholders are typically in-house staff, although it is not unusual for contractors to be part of the team, especially during tool development and implementation stages when the workload may be significantly higher.

Taxonomy management consists of the initial creation of taxonomies and related vocabularies and their maintenance over time. The responsibility of taxonomy management personnel is to execute policies created by the governance team, report to the governance team on taxonomy status and performance, and provide expert advice on taxonomy capabilities to inform decisions on future taxonomy development.

The tasks that are part of initial taxonomy development are quite different from those that are required during ongoing maintenance and administration. Those differences may require changes in emphasis on the part of the governance team, including team make-up and activities, depending the stage of the taxonomy life cycle.

Taxonomy development should be driven by business requirements, working within organizational and technical constraints. Both requirements and constraints should be defined by the governance team, thus the taxonomy management representatives on the team must be sufficiently conversant in both business and technical issues to productively collaborate with team members from other disciplines. Next, execution of taxonomy development will require collaboration between taxonomists and subject matter experts to create vocabularies that represent relevant concepts using terminology that is accurate and meaningful to users.

Some of the questions that taxonomy management staff will answer for the governance team include:

• What specific taxonomies are required to meet business needs?
• Will these taxonomies need to be developed from scratch or can existing taxonomies be reused?
• Are there vocabularies, organizing principles or other classification methods currently in use within the organization that can be harvested and reused?
• Are there standard domain-specific taxonomies, thesauri, or ontologies that will satisfy the requirements, either as is or with modification?
• Are implemented taxonomies meeting user and business needs?
• What changes are needed to improve taxonomy performance?

Staff for both taxonomy development and administration can be either in-house or provided by a consultant. Staffing needs vary greatly between organizations and details of the taxonomy implementation should be considered carefully when staffing decisions are made. The initial development and implementation of specialized taxonomies can be a substantial amount of work and it is common to make use of consultants for this phase of the project.

However, the costs for long-term administration should not be underestimated. Costs rise when organizations do not anticipate staff and resources needed for taxonomy maintenance. More importantly, without maintenance, taxonomies will atrophy and the value they provide to the organization is greatly diminished. Taxonomy management representatives provide the governance team with accurate assessments of taxonomy status as well as short and long-term resource needs.

The list below describes the functional roles performed by a taxonomy governance team and lists the team members who are typically associated with a given role. The individuals fulfilling the roles will vary depending on the structure, management philosophy, and staffing model of the organization so these descriptions should be considered as general guidelines rather than specific job titles. It is also not uncommon for an individual an on the team to play more than one role.

Executive Sponsors - provide strategic guidance, advocacy and support for taxonomy projects within the organization.

Business Decision Makers - identify business objectives, resolve cost/benefit issues and oversee resource allocation for taxonomy projects.

Technology Implementation and Support - develop and support taxonomy management tools or manage integration of third-party tools with relevant systems and organizational IT infrastructure.

Taxonomy Management - responsible for high- and low-level execution of taxonomy strategy and day-to-day taxonomy administration. May be an in-house team, an outside consultant or a mix.

Taxonomy Consumers - systems, groups, and individuals that use taxonomy in their day-to-day business operations. Typical consumers include content management, content strategy, user experience and web design, writing and publishing, site search, SEM and SEO, and business intelligence.

Subject Matter Experts - provide expert advice on intellectual domains, business processes, and other subject areas described by organizational taxonomies. Subject matter experts may or may not also be taxonomy consumers.

There is no universal taxonomy governance solution. Rather, effective governance achieves an important set of general goals while recognizing the unique features of an organization. Establishing a taxonomy governance Team is very important.

Galaxy Consulting has 18 years experience in taxonomy development, management, and governance. Please call us today for a free consultation.

Change Management and Content Management

Content Management and Change Management are connected. Change Management is needed for successful Content Management. These two subject matters support each other.

Companies can benefit from the positive relationship between these two subject matters and suitable processes about them, starting with content management. 

Improved visibility and management of documents is particularly beneficial for change management. Employees across an organization can use the same, current documents with up-to-date facts and figures, and with an automated document management system, they can do it quickly, boosting the organization’s agility in times of change.

When Content Management Takes the Lead

With a reliable and efficient content management system, individual departments and change management teams can better:

• Integrate siloed information and standardize operating procedures across the organization, thereby allowing everyone to pull from a single source of truth.
• Communicate any changes quickly throughout the entire organization.
• Increase product and process quality by ensuring employees have the right document at the right time.

By-products of these activities include improved decision-making and reduced possibility of errors, miscommunication, and regulatory actions through enforced compliance. In short, Content Management helps keep Change Management in control.

When Change Management Takes the Lead

How does change management helps to keep the content management processes in check? Whether change is driven by FDA, EMEA, or ISO regulations, or by competitive business forces, it is undeniably critical to operations. It doesn’t matter whether the change being addressed in an internal change, or a process change that must be efficiently and accurately documented to ensure adherence going forward. It must be kept in control, and to do so, it commands that other inter-related processes, including content management, be reliable at all times.

To effectively manage change, an organization must be agile. Bottlenecks to operational agility might include an inability to locate data, or outdated SOPs that expose the company to noncompliance or financial, operational, or legal risk. These bottlenecks might rest within the content management processes, rendering them unreliable. Change Management would help to resolve these problems.

An effective change management system will take charge and guide content management by starting document updates during the implementation of an approved change. This action:

• Provides a comprehensive workflow for documenting change from the initial change request through to the approvals and implementation.
• Reduces the risk of losing documents, or storing incomplete or unapproved documents.
• Increases the available transparency of what is being documented.

Content Management and Change Management are Better Together

On their own, these subject matters are strong but together they are extremely agile, and they drive continuous improvement and overall organizational quality. They are also high-achievers in the higher-level view from Quality Management point of view. Working in tandem, Content Management and Change Management benefit Quality operations through:

• Accessibility: Organized, current, and visible documentation provides an easily accessible audit trail to keep the organization on track and to satisfy regulatory requirements at a moment’s notice.
• Collaboration: When electronic change requests integrate with electronic document management, they expedite the document update process and enhance project collaboration among impacted departments and functions.
• Security: Concise storage and accessibility of current documents, particularly SOPs, ensures that the right individuals are receiving the right documents at the right time. When change is in the focus, incomplete documents or those not applicable to certain departments cannot be accessed through a “back door.”

Organizations Should Consider Adoption

Organizations would do well to adopt both quality management processes, whether on their own or as part of an automated enterprise-wide Quality Management System (QMS).

An effective automated system will integrate document and change control procedures. It also will integrate with other solutions, providing access to approved, controlled documents in other areas of the quality system, including audits, CAPAs and employee training. In these cases, an automated system’s search and retrieval capabilities, dashboards, and repositories expedite the processes.

Industry standards and regulatory guidelines recommend quality management processes which are integrated across the entire organization.

Content Naming Conventions

File Naming Conventions (FNC) is a framework for systematic naming files in a way that describes what they contain and how they relate to other files. Developing FNC is done through identifying the key elements of the file, the important differences and commonalities between files.

How files are organized and named has a big impact on the ability to find those files later and to understand what they contain. File names should be consistent and descriptive in naming and organizing so that it is obvious where to find specific files and what the files contain.

To ensure maximum access to files, it is necessary to establish a naming convention for files and use it consistently.

Here is the situation: you need to review the most recent version of a document. You login to your organization’s content management system (CMS) and look for the file, but you can’t tell which of the documents you should be reviewing because files' names are meaningless.

This is just one small example of an information management weakness that can cause a lot of unnecessary frustration. Imagine how much more productive you and your colleagues could be if you knew what each file contained before you opened it!

Therefore file naming conventions are very important because the more organized you can be with managing your information, the more effective and efficient you can be your work.

A file naming convention is a systematic method for naming files. Your file naming convention will always be your most powerful and easy method for organizing and retrieving your documents. You want to get this right the first time, so it is important to invest enough time to think about this carefully.

A consistent and descriptive file naming convention serves many purposes, often related to branding, information management, and usability. The overall goal of optimal file naming is to increase readability in file names. It empowers people to navigate files more easily, makes searching and finding documents easier by having your file names reflect file contents, and guides file authors to develop each document around a single, concrete purpose, which reduces clutter. More concretely, it allows you to:

• know the content of a document without opening it;
• retrieve and filter documents very quickly using the search/filter function of your computer;
• store documents in a single folder without losing their context, if you need to;
• find and identify documents even if they are no longer in their original folder;
• easily browse long lists of files to inventory or check for missing documents;
• manage documents more easily on your website.

As you can see, there are many situations in which it is helpful to have file naming conventions. It is necessary to have it in order to organize your organization’s files so that users can find what they are looking for.

One way to know if you need to pay some extra attention to the way you are naming your files is to take golden test of a good file naming convention: imagine if you take all your files from your whole organization, and put them into one single folder.

Can you still quickly filter down to what you want by scrolling through the file list? Or by searching for elements of file names? If the answer is yes, your file naming is good. If not, your file naming still needs some work.

Tips for designing your file naming convention

1. Consider how you want to retrieve the files

How you want to retrieve the files will help determine the right file naming convention for that file type. Keep in mind that file sorting will read from left to right.

Starting your file name with the most important parameter/component will allow you to organize documents alphabetically (or chronologically) with that parameter without having to do any searching.

For example, if your primary method of accessing a litigation case file is its number, then this should be the first element in your file naming convention: when you sort your documents in the file manager, you will see them by case number first.

To ensure that files are sorted in proper chronological order the most significant date and time components should appear first followed with the least significant components. If all the other words in the file name are the same, this convention will allow you to sort documents by year, then month, then date.

Some conventions have the date in the front of every filename because that is the most logical way for their team to retrieve files. If the document will be maintained over time, use the convention v1, v2, v3, etc. to depict its place in the sequence of versions. You may want to separate the “v” from the content type with an underscore (“_”). As versions are made and updated, change the version #, but keep the file name the same.

Make sure that, if there are going to be more than 9 files with that name (versioning, photos), it should be 01, 02, 03,.. so that it can be sorted in chronological order. Same if it is more than 99 files, it should be -001, -060, -099, -100.

2. Use relevant components in your file name to provide description and context. The file name should contain the essential elements of each file, dependent upon what is suitable for your retrieval needs. File names should outlast the records creator who originally named the file, so think about what information would be helpful to someone in 15 years.

Keep in mind you will most likely want to use agreed-upon abbreviations for these components in order to keep the file names short.

For example, a file naming convention may include the following components, in the following order [YYMMDD]_[Project]_[Country]_[Event]-[number].xxx

Examples of filenames based on this convention:

160301_HRC_Geneva_launch-001.jpg

151208_HURIDOCS_Casebox_Improvements.pdf

160126_HURIDOCS_EHRAC_meeting_notes.rtf 160219_SRJI_Moscow_meeting-001.jpg

3. Keep the filename a reasonable length

Long file names do not work well so it’s best to keep them short. To achieve this, you could consider:

• shortening the year to 2 numbers;
• abbreviate file name components (e.g. use “inv” instead of “invoice”, or “fr” instead of “francais”);
• use as few words as possible to convey the identity of the document;

4. Avoid special characters and spaces Special characters such as ~ ! @ # $ % ^ * ( ) ` ; ? , [ ] { } ‘ ” | should be avoided. Do not use spaces. Some software will not recognize file names with spaces. Use these alternatives instead: Underscores (e.g. file_name.xxx), Dashes (e.g. file-name.xxx), No separation (e.g. filename.xxx), Camel case, where the first letter of each section of text is capitalized (e.g. FileName.xxx).

5. Do not start the file name with special characters under any circumstances.

6. Document and share your file naming convention, and get your team on-board.

Make it easy to understand, use and find the file naming conventions by documenting them and putting them in a place that is easy to find.

Hold a short and fun internal training session to explain why the new file naming conventions are so important to use, and how they work. Create a video that goes through the key points of these conventions.

Example of a digital photo file naming convention

Professional photographers also use file naming conventions to organize their photos. A photographer may take thousands photos in a single shoot, and they do not depend on file names produced by their camera, or rely on folder structures. Rather, they typically use a file naming convention, such as: [Date] – [place or event] – [number] – [comment].

Examples:

2011.11.11-kampala-riot-000001.tiff

2011.11.11-kampala-riot-000002.tiff

2011.11.11-kampala-riot-000003.tiff

2011.11.11-kampala-riot-000004.tiff

2011.11.11-kampala-riot-000004-cropped-slider660x510.jpg

As you can see, the photos above relate to riots that took place in Kampala on 11 November 2011. They were shot in TIFF format. The last photo is derivative of the previous one: it is an image cropped for the slider. Even if there are tens of thousands of photos in the same folder, it’s easy to filter for “kampala” and “riot”. Photography software like Adobe Lightroom or Adobe Photoshop allows you to batch rename files as above.

Example of using a file naming convention when scanning documents

If you’re using a scanner to digitize documents, it will typically produce PDF documents with filenames like 20120202095112663.pdf. This is not helpful for browsing thousands of documents! Instead, using a file naming convention will result with document names like the following: ICJ-submission-CAT47-Greece-20111011.pdf.

You can guess what this document is about without opening it. In this case, it is a submission by the International Commission of Jurists to the Committee Against Torture at its 47th session, on 11 October 2011, concerning Greece.

Enjoying the fruits of your labor: how to find your file

Using consistent file naming conventions will let you find content you are looking for.

Galaxy Consulting has 20 years experience in content naming conventions. Please contact us for a free consultation.

Taxonomy Governance

When organizations have the need for a taxonomy, they focus on taxonomy development and they do not take into consideration the need for taxonomy governance. Taxonomy governance is part of information governance and should be taken seriously.

Taxonomies exist to support business processes and the associated organizational goals. A well-managed taxonomy provides the structure needed to manage content across multiple internal systems and gives users options and flexibility for how content is accessed and displayed. Taxonomy governance plans ensure that the taxonomies are maintained in a way that satisfies current and future needs and provides the maximum return on investment.

Taxonomy governance consists of the policies, procedures and documentation required for management and use of taxonomies within an organization. Successful taxonomy governance establishes long-term ownership and responsibility for taxonomies, responds to feedback from taxonomy users, and assures the sustainable evolution of taxonomies in response to changes in user and business needs.

Taxonomies are never “finished.” Rather, they are living systems that grow and evolve with the business. Taxonomy governance ensures that growth happens in a managed, predictable way.

Taxonomy governance answers the following questions:

• Who are the taxonomy stakeholders?
• What are their respective responsibilities?
• Who is responsible for making changes?
• What is the process for making changes?
• How are prospective changes evaluated and prioritized?
• When are changes made?
• When are processes reviewed and updated?

The goals of taxonomy governance are similar across organizations but it is important to remember that there is no universal taxonomy governance solution. Successful taxonomy governance works within the context of the organization.

Many of the principles and goals of taxonomy governance are shared with information governance.

A good first step when developing taxonomy governance policies is to examine related information governance policies that already exist within an organization. Re-purposing familiar policies and systems makes both adoption and compliance easier for taxonomy users.

The best governance policies take advantage of existing structure, workflows and management processes while accounting for human and technical resources and constraints. Governance policies provide a strategic framework to guide day-to-day taxonomy management.

The main components of this framework are the taxonomy management organization and the operations they perform. Governance has a role at both strategic and operational levels by defining roles and responsibilities of taxonomy organization members, articulating communication, decision-making and escalation policies and providing protocols for taxonomy maintenance operations. Above all, governance provides accountability for decision-making and operations on both a large and small scale.

Taxonomy Management

Ongoing maintenance and development of a taxonomy is best achieved by a formal organization with well-defined and clearly documented roles, responsibilities, and processes. The Taxonomy Management team should be responsible for both strategic direction and routine administration of taxonomy operations. This team should include high-level decision-makers as well as trained taxonomists and IT if needed. End users of the taxonomy should also be represented in the Taxonomy Management team.

The role of a taxonomy governance team is to ensure that taxonomy management occurs in a systematic, measurable, and reproducible way. It provides a mechanism for managing the needs and concerns of all taxonomy stakeholders and helps maximize the value of taxonomy resources by establishing organization-wide policies for taxonomy development, maintenance and use.

Taxonomy Management Team manages taxonomy administration and development. As with governance policies in general, the specific makeup and divisions between teams as well as the terminology used to describe them will vary depending on the particulars of organizational structure, history and goals.

Taxonomy governance focuses on strategic goals and company-wide policies for taxonomy management and use as well as levels of responsibility for different taxonomy stakeholders. These goals and policies are developed by the Taxonomy Governance Team.

Identifying and documenting organization-wide taxonomy use cases is very important task of taxonomy governance activities. Taxonomies can potentially be used in multiple business areas. Content strategy, web design and user experience, marketing, customer support, site search and business intelligence are a few examples. Developing tangible, specific use cases helps communicate the taxonomy’s value throughout the organization and is necessary when prioritizing taxonomy-related investments.

Governance policies should also be developed that define taxonomy success, performance and quality. Metrics should validate the quality of a taxonomy implementation through quantifiable, direct measurement of taxonomy performance. Regular assessment ensures that the taxonomy meets business and user needs over the long term.

The ability to share data across systems, improved quality of search results, improved user experience of websites and regulatory compliance resulting from effective record keeping and document management are all examples of benefits that can result from effective taxonomy implementation and management. A goal of governance should be to identify and document benefits of this type that are relevant to the specific organization.

Taxonomy Operations and Maintenance

Ongoing maintenance is very important aspect of a taxonomy project. Taxonomies must be continually updated to reflect changes in content, competition, and business goals. In the absence of maintenance taxonomies atrophy and the value they provide will be greatly diminished.

Organizations must anticipate the resources needed to maintain the taxonomy and develop effective management processes to realize the maximum value from their taxonomy investment. At this level governance is primarily focused on operational details. It provides the framework for taxonomy operations in the form of guidelines, processes, documentation and a defined organizational structure.

The specific tasks performed as part of taxonomy maintenance consist of a wide range of large and small-scale changes to the taxonomy. Taxonomy staff are also typically responsible for providing training, preparing documentation materials, interacting with IT groups to ensure smooth operation of taxonomy systems and providing expert advice and feedback to business leaders to inform strategic decision-making.

The Taxonomy Change Process

One of the most important purposes of taxonomy governance is to define the organizational taxonomy change process. Governance policies define and document specific taxonomy changes and provide guidance to taxonomy administrators on making those changes.

It is especially important to provide guidance on decision-making authority and escalation processes. Defining and documenting different change types allows rational decisions to be made as to which changes can be routinely handled at the discretion of taxonomy administrators and which changes require higher-level consensus and approval. The first step in defining a taxonomy change process is to categorize taxonomy changes by impact and scale.

An important consideration in categorizing the impact of changes to the taxonomy is that taxonomy data is often used by multiple internal tools and systems. Content management, marketing, web analytics and SEO, product inventory and web publishing systems are just a few potential consumers of an enterprise taxonomy.

Experience shows that the level of engagement with the taxonomy team varies widely between users. To avoid unpleasant surprises, taxonomy administrators should be proactive in tracking users and systems where taxonomies are used. Understanding and documenting both the technical details of how taxonomy data flows to these systems and the specific business use case of various users is an important part of the taxonomy change process and should be addressed in both change processes and communication plans.

Small-scale changes will affect only a single term or small number of terms and will have a minimal impact on users and systems where they are used. Typical small-scale changes are spelling corrections or the addition of individual terms to existing vocabularies.

Taxonomy management staff is usually empowered to make this type of changes as part of routine taxonomy administration. In contrast, large-scale changes will impact large numbers of taxonomy consumers, multiple consuming systems and/or require a significant commitment of taxonomy management resources for an extended period of time. They require high-level approval with input from the entire information governance team.

Change Request Process

Typical sources of taxonomy change requests are users feedback, routine maintenance by taxonomy administrators, and new business needs.

User feedback is usually the largest and most important source of small-scale taxonomy change requests. A channel is needed for users to provide feedback and for taxonomy administrators to communicate with users. Interacting with taxonomy users and serving as a general point of contact for taxonomy issues is one of the most important aspects of routine taxonomy maintenance for taxonomy administrators.

Email aliases, bug/issue tracking software, dedicated portals, message boards, and other tools used in a help desk or customer support setting are all potentially useful mechanisms for taxonomy administrators to interact with users. Governance policies should address these needs with a well-defined communications plan.

It is also common for predictable events to have an impact on the taxonomy. Marketing campaigns, product updates, new products, company reorganizations and mergers are a few examples of events that could lead to taxonomy changes. Changes of this type can be significant in terms of scale but they can usually be handled as a routine part of taxonomy maintenance. These events should be identified and relevant change and communication policies developed.

In contrast to small-scale changes, large-scale changes tend to be infrequent and are typically driven by strategic business needs. Major expansions in scope requiring the creation of large numbers of new terms and implementation of significant new systems or technologies are examples of large-scale taxonomy changes that may be needed.

Difficulty and scale of taxonomy changes is dependent on the specific details of its implementation. Management of the taxonomy with a dedicated taxonomy tool versus within a content management system, the capabilities of the tool being used, the number and complexity of taxonomy use cases and the number and characteristics of consuming systems are a few variables that will influence the change process.

Collecting statistics on change requests and taxonomy use should be part of taxonomy administrator’s routine responsibilities. This data should be reported to the governance team and used to inform strategic decision-making. In the same way decisions made at the strategic level will impact the prioritization and performance of day-to-day tasks.

Maximizing ROI on Taxonomy Investments

Quality control mechanisms are an important function of governance, especially for businesses that operate in highly regulated environments, but they are not the only, or most important purpose of governance.

The high-level goal of taxonomy governance is to maximize the return on taxonomy investments. The taxonomy governance team establishes strategic goals for the taxonomy and develops organization-wide policies for taxonomy management and use designed to meet those goals.

Goals, policies and procedures should not only be designed to mitigate risks but also to improve organizational performance and capabilities. An enterprise taxonomy is used by many different individuals, groups, and systems and can impact multiple business processes. All of these stakeholders should have insight into taxonomy management processes and a mechanism to provide feedback. Because of the breadth of business processes using the taxonomy it is also important that the governance team include high-level representation to provide strategic guidance and advocacy for taxonomy operations. In return, the governance team must communicate the positive benefits to stakeholders so that policies are more than just vague background noise.

One of the most important tasks of a governance team is to communicate these policies and procedures in a positive way. Governance is often perceived as an enforcement mechanism and it’s natural for stakeholders to react defensively if they believe that policies are in place because they’re not trusted to produce high-quality work. Processes, standard operating procedures, responsibility matrices and so on are viewed as a an active obstructions to productive work.

Galaxy Consulting has 20 years experience in taxonomy development and taxonomy governance. Please contact us for a free consultation.