In 1987 the FDA published a document entitled ‘FDA Guidelines on General Principles of Process Validation’. It states the following:
Process Validation is 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
This definition indicates that validation can apply to any process including process managed/controlled by computer systems.
Validation – Why Needed
FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.
Software is constantly evolving to keep up with the increasingly complex needs of the people that use it; therefore validation is an ongoing necessity.
Failure to take corrective action in a timely manner can result in shutting down manufacturing facilities, consent decrees, and stiff financial penalties; hence validation is an insurance for Risks and Legal Liabilities.
Prospective Validation – Validation of a new system as it is developed
Retrospective Validation – Validation of an existing system
- Validation Master Plan (VMP)
- Project Plan
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance or Process Qualification (PQ)
What We Offer
We work with your team as external agency and play a catalytic role in building sustainable expertise.
- On-time Service Delivery
- On-call Assistance
- Guidance and handholding for a sustainable outcome
- Application Management Service (AMS)
- Business Process Management (BPM)Consulting
- Process Consulting
- Capability Building