Consequences of GxP/GMP for Information Technology

In my last post, I described the GMP requirements for document control. In this post, I am going to describe the GMP requirements for information technology used in a GMP company.

For a drug to be produced in a GxP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements such as:

• secure logging: each system activity must be registered, in particular what users of the system do, that relate to research, development and manufacturing. The logged information has to be secured appropriately so that it cannot be changed once logged, not even by an administrative user of the system;
• auditing: an IT system must be able to provide conclusive evidence in litigation cases, to reconstruct the decisions and potential mistakes that were made in developing or manufacturing a medical device, drug or other regulated product;
• keeping archives: relevant audit information must be kept for a set period. In certain countries, archives must be kept for several decades. Archived information is still subject to the same requirements, but its only purpose is to provided trusted evidence in litigation cases;
• accountability: Every piece of audited information must have a known author who has signed into the system using an electronic signature. No actions are performed by anonymous individuals;
• non-repudiation: audit information must be logged in a way that no user could say that the information is invalid, e.g. saying that someone could have tampered with the information. One way of assuring this is the use of digital signatures.

GMP guidelines require that software programs must be validated by adequate and documented testing. Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. The software validation guideline states: “The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes."

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.

It is important to notice these requirements since a document management system is required to control documents, so this document management system must meet these requirements for information technology.