Ø What is Computer System
Validation and Why is it Important?
Establishing documented evidence which provides a
high degree of assurance that a computer System will consistently produce
results that meet its predetermined specification and quality attributes.
There
are two key reasons why Computer System Validation is extremely important in
the Life
Science
sector:
1. Systematic Computer System
Validation helps prevent software problems from reaching production
environments. As previously mentioned, a problem in a Life Science software
application that affects the production environment can result in serious
adverse consequences. Besides the obvious humanistic reasons that the Life
Science sector strives to prevent such harm to people, the business
consequences of a software failure affecting people adversely can include
lawsuits, financial penalties and manufacturing
facilities getting shut down. The
ultimate result could be officers getting indicted, the company suffering
economic instabilities, staff downsizing, and possibly eventual bankruptcy.
2. FDA regulations mandate the
need to perform Computer System Validation and these regulations have the
impact of law. Failing an FDA audit can result in FDA inspectional observations
(“483s”) and warning letters. Failure to take corrective action in a timely manner
can result in shutting down manufacturing facilities, consent decrees, and
stiff financial penalties. Again, the ultimate result could be loss of jobs,
indictment of responsible parties (usually the officers of a company), and
companies suffering economic instabilities resulting in downsizing and possibly
eventual bankruptcy.
Relationship Between Computer
System Validation and 21 CFR Part 11
The FDA added rule 21 CFR Part 11
to the Code of Federal Regulations .This regulation introduces specific
controls on the use of electronic records and includes strict administrative
controls on electronic signatures. These controls deal with:
1. Making electronic records
suitable for supplanting paper records.
2. Making an electronic signature
as secure and legally binding as a handwritten signature.
Regardless of whether or not a
company uses electronic signatures, 21 CFR Part 11 impacts all
companies that use computer
systems that create records in electronic form associated with the GxP
environment .All computer systems in this category must have technical and
administrative controls to ensure:
1. The ability to generate
accurate and complete copies of records
2. The availability of
time-stamped audit trails
3. The protection of records to
enable accurate and ready retrieval
4. Appropriate system access and
authority checks are enforced