Having designed, managed and commissioned high profile validated BEMS projects in the Pharmaceutical and Medical Devices Industry, we have in-depth knowledge and experience in FDA 21CFR Part 11 Directives for the HVAC Industry.
Examples of high level documentation required under these directives are:
- Functional Design Specifications (FDS)
- Hardware Design Specifications (HDS)
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Commissioning Document Protocol