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