Technical Writing | Validation & Compliance for Computerized Systems

Generation, Re-Visioning & Execution of Validation Documentation

Area: Greater Los Angeles Area
Project Type: Technical Writing

About this Project

OBJECTIVE

Required support for the compliance and validation activities related to the Software Transition Project for 12 months.

SERVICES

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.

EQUIPMENT USED

“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

PROJECT SUCCESS

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.