Quality can not be tested in to the system it must be designed. This is why developing a lifecycle approach to software validation should be taken, to design in quality from concept, through the requirements, design and implementation.
To assure quality and cGMP compliance the quality requirements must be considered early in the project. During the specification phase an initial risk or impact assessment should be performed to determine the validation requirements. This should be documented within the Validation Plan.
The Validation Plan should consider the quality assurance that will be placed throughout the project to provide a system which meets regulatory requirements.
The article Validation of Process Control Systems provides an overview to the lifecycle approach for Software / Computer System Validation. This considers each of the phases:
- Specification, Vendor Selection and Planning
- Design
- Verification and Release
- Operational Compliance
This document, still in its early stages, to be expanded by articles relating to the key steps and related documents, including
- Validation Planning
- Supplier Auditing
- Testing and Verification
- Validation Reporting
Comments for discussion are always welcome.
No comments:
Post a Comment
All comments on the computer systems validation blog are welcome.