Validation & Verification

Comprehensive Computer System Validation

Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology or Software Control application fulfills its intended purpose. Stringent quality requirements in FDA regulated industries impose the need for specific controls and procedures throughout the Software Development Life Cycle (SDLC). Evidence that these controls and procedures have been followed and that they have resulted in quality software (software that satisfies its requirements) must be documented correctly and completely.

These documents must be capable of standing up to close scrutiny by trained inspectors since the penalty for failing an audit can be extremely high. More importantly, a problem in a Life Science software application that affects the production environment could result in serious adverse consequences, including possible loss of life.

The activities involved in applying the appropriate controls/procedures throughout the SDLC and for creating the necessary trail of documented evidence are all part of the technical discipline of Computer System Validation.

A “Computer System” in the Life Sciences sector is more than computer hardware and software. It also includes the equipment and instruments linked to the system (if any) as well as the trained staff that operate the system and/or equipment using Standard Operating Procedures (SOPs) and manuals.

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 closures.
  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.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.

A key point to be gleaned from 1 and 2 above is that not only do FDA regulated companies need to do Computer System Validation, but they need to do it right.

Clarke Solutions is experienced in CSV as a stand-alone activity as well as CSV integrated with C&Q testing. Our Computer System Validation services include:

  • System and software code reviews
  • Complete software documentation processes including software design and traceability
  • Validation execution
  • Electronic equipment records and logical security
  • Integration with data logging (historian) systems
  • System backup and restore preparation
  • Oversight of vendor source code

For more information about Clarke Solution’s Computer System Validation, contact us here or call 327.849.0330 today for a free, no-obligation risk assessment.