Computer system validation (CSV) has become essential in the drug and medical device industry. The FDA defines process validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”(1) Validation requires evidence that a process is clear, repeatable and will stand up to audits. CSV is able to generate documented evidence that every part involved in the manufacturing process will work correctly every time.
CSV requires a comprehensive plan. The creator of such a plan should understand the regulatory environment as well as the scope of the business process. Some key components of any validation plan are:
- A risk assessment
- A complete, systematic plan detailing the project and who and what is required to complete it
- Detailed steps to be taken to provide the evidence necessary to validate the system
- A plan for testing each segment of the project
- Test cases to determine test results
- A summary of the validation plan
- A roadmap for procedures after validation has been completed
There are four critical areas that impact and drive the cost of change: People, Process, Performance Management and Organization. The right CSV program ensures these critical areas
are aligned and optimized, allowing industry change and conformance to new regulations to be implemented at a lower cost and with higher efficiency. Success in the industry is dependent on the ability to operate with quality, efficiency and compliance.