Software System Validation 

PSC Biotech provided eight years of Computer System Validation (CSV) services to the client during development and commercialization.

  • Area: Bay Area
  • Project Type:Computer System Validation (CSV)

About this Project

OBJECTIVE

The goal of this project is to provide computer system validation (CSV) services for software developed and commercialized by the client.

SERVICES

PSC Biotech provided the client the following:

  • Development of Installation (IQ) and Operational Qualification (OQ) Test Scripts for the client’s Software as a Service (SaaS) application
  • Execution and Post Execution Review of IQ and OQ Test Scripts
  • Development of a Traceability Matrix
  • Development of System Release Memo

Project Success

The project is an ongoing success, PSC executes and completes the CSV services, ensuring the client can release its application on schedule, 3 times per annum and maintains an excellent level of regulatory compliance.  .

 

Related Projects

20 Years & Counting of CQV Services

Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

Cleaning Validation & Decommissioning Project

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

Sterile Fill/Finish Laboratory Facilities CQV Project

The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.

How Can We Help You?

[ninja_form id=6]