Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

  • The US FDA
  • European Medicines Agency (EMA)
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices (GCP)
  • All the Predicate Rules

Reasons for which Computer Systems need to be validated

The most important rationale for CSV, apart from its being required for the above stated, is that it is a very effective step towards ensuring the consistency of data and the quality of the product. This aside, CSV also helps in the protection of intellectual property (IP) by being a source that supplies data that is scientifically valid.

The 21 CFR Part 11 standard


The 21 CFR Part 11 standards, sometimes referred to as just Part 11, apply to the life sciences industry and consist of the criteria that the US FDA sets out for electronic records, electronic signatures and handwritten signatures. Its main purpose is to ensure that electronic records have the same equivalence as paper records as well as handwritten signatures.


Problems with Part 11 implementation

In the life sciences industry, the major challenges relating to adherence to Part 11 can be summarized as below:

  • Ensuring the accuracy of data and the security of information
  • Containing or preventing the loss of revenue from this exercise as well as to its business
  • Properly and sufficiently assessing gaps in the systems.

The costs of not getting Part 11 right can be high for companies:

They can have their New Drug Application (NDA) denied; they can experience a potential delay in their manufacturing actives, or can invite any of these:

  • Warning Letters
  • 483
  • Civil penalties
  • Possible prosecution if the investigation shows up negligence on their part


What are the steps for carrying out an effective Computer Systems Validation?


The validation process for 21 CFR Part 11 compliance consists of these core elements:

  • Comprehending the regulatory requirements
  • Taking steps for ensuring compliance with CSV requirements in a cost-effective manner
  • Carrying out testing of software and computer systems – initial and ongoing
  • Ensuring that the bare minimum documentation that FDA inspectors will ask for are available
  • Qualifying the IT systems network infrastructure and validating the network systems