Technical Writing | Validation & Compliance for Computerized Systems

Generation, Re-Visioning  & Execution of Validation Documentation
  • Area: Greater Los Angeles Area
  • Key Account Manager: Nancy Huang
  • 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.

computerized system

Nancy Huang

Director of Operations

sales@biotech.com

computerized system

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.

Related Projects

Engineering Projects & New Equipment Implementation

Required technical writing support for engineering projects and new equipment implementation.

Conducting Investigations & Resolving Nonconformance’s

Generated Standard Operating Procedure’s for Equipment Facilities and Utilities.

Extensive Technical Writing & Validation Execution

PSC provided project schedule oversight the multiple technical writing projects.

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