Systems used for regulated activities are required to be validated to ensure accuracy, reliability, and consistent intended performance. The regulators themselves publish little information on HOW systems are to be validated.
Good Automated Manufacturing Practice (GAMP) guidance is published by the ISPE with the aim of producing a standardised framework for the Qualification of computerised systems meeting all regulatory expectations and building on industry best practice. GAMP uses a catagorisation system which suggests an approach based on level of customisation and complexity.
ADN are experienced at the planning, management and execution of systems validation. By using requirements and traceability management techniques we can:
- Create "Good" requirements which comply with regulatory requirements, successfully capture the real customer need and are testable.
- Provide complete traceability to ensure full test coverage
- Easily identify the impact of any changes
By using risk assessment techniques we ensure that the majority of the testing is directed at high risk or high impact areas.
