In a regulated plant the control system and its documentation are inseparable. A change that is not evidenced did not happen, as far as an inspection is concerned.
Delivered against the V-model
- User requirements and functional specifications traceable to each test case
- Design qualification, followed by installation and operational qualification documentation
- Audit trails and access control meeting 21 CFR Part 11 and Annex 11 expectations
- Data integrity controls covering record creation, amendment and retention
- Change control procedures handed over with the system, not written afterwards
Working with your quality function
We expect quality assurance to review our documents, and we plan for the review cycles rather than treating them as an overrun. Our engineers are used to defending a design decision in a quality forum.
Periodic review
After qualification the system enters periodic review. We can support that as part of a managed support agreement, which keeps the people who hold the design knowledge involved in the assessment.