Validation and 21 CFR 11 Compliance

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Validation and 21 CFR Part 11 Compliance
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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.
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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

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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.
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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.
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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.

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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

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What are the steps for carrying out an effective
CSV ?

• 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

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• 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
• References
• http//globalcompliancepanel.viewpage.co/Validatio
  n-and-21-CFR-11-Compliance

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