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Showing posts with label Document Control. Show all posts
Showing posts with label Document Control. Show all posts
Saturday, March 28, 2020

Purpose of Document Control and its Role in Quality Assurance

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GxP/GMP, GDocP, ISO 9000 and documentation GxP stands for "Good Practice" which is quality guidelines and regulations. The ...
Wednesday, July 31, 2013

ISO 9001 and Documentation

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ISO 9001 compliance becomes increasingly important in regulated industries. How does it affect documentation? Here is how... What is...
Monday, June 18, 2012

Document Control Systems Reviews - Arena

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There are few applications specifically designed for document control. Arena is one of them and it is the subject of my today's post. A...
Monday, May 14, 2012

Document Control System Implementation

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Document control is revision control of documents, assigning and tracking documents numbers, change control management, assuring documen...
Wednesday, February 15, 2012

Change Control in the Regulated Industries

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In my last post, I described change control process in general and I mentioned that in the regulated industries, manufactures are requir...
Tuesday, February 14, 2012

Change Control

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Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that c...
Monday, January 9, 2012

Consequences of GxP/GMP for Information Technology

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In my last post, I described the GMP requirements for document control. In this post, I am going to describe the GMP requirements for in...
Friday, January 6, 2012

GxP/GMP and Document Control

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In the regulated environment, the document control is the cornerstone of the quality system. It is so important that if an external audi...
Thursday, January 5, 2012

ISO 9001 and Document Control

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ISO 9001 specifies requirements for a Quality Management System (QMS) where an organization needs to demonstrate its ability to consiste...
Wednesday, December 7, 2011

Engineering Change Process

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Let's look at the engineering change process and how Engineering Change Order (ECO) is used in this process. The stages of the en...