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.