Technical Writing | Validation & Compliance for Computerized Systems
About this Project
Required support for the compliance and validation activities related to the Software Transition Project for 12 months.
PSC provided Validation and Compliance Technical Writing for the transition of computerized systems for the client. Responsibilities included but were not limited to generation, re-visioning and execution of the following SDLC validation documentation: Compliance Analysis, Compliance Plan, User Requirements, Functional Requirements, Test Protocol, Test Execution, Traceability Matix, and Compliance Report of the computerized systems.
- “FPC50W – Isolator (Watson Marlow-Ziel)
- FlexPro 50 – Isolator (Groninger – Ziel)
- Steris Autoclave (27 cu ft. production)
- Santimatic COP washer
- Seidnator (2)
- Innova Deneste
- USP water, Pure steam, Compressed air, Nitrogen, AHUs, Water for Injections. -Not tools used
Over this year long project, the PSC Project Team, which consisted of 5 Validation Engineers, successfully maintained a strict timeline and adhered to the project budget, along with successfully completing the technical writing, validation compliance of the transition of the computerized system.