We offer exceptional validation support throughout design, assembly, debug, and acceptance testing of your equipment.
We’ve incorporated the requirements of ISO 9001:2015 and GAMP® 5 into all of our processes, creating an environment geared toward supporting your validation efforts.
We provide thorough and consistent tracking of requirements from concept to delivery, including specification and revision approvals, documentation traceability, and test protocol design and implementation.
Our regulatory experience includes:
- ISO 9001:2015
- GAMP® 5
- 21 CFR Part 11
- 21 CFR Parts 210 and 211