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

NHuang@biotech.com

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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