About this Project
OBJECTIVE
This project aimed to provide a complete spreadsheet validation package (including the master plan, Risk Assessments, User Requirements Specifications, Protocols, Executions, Trace Matrices, and Summary Reports) for all Excel spreadsheets used in the laboratories for GMP purposes.
SERVICES
PSC Biotech consultants drafted the required validation lifecycle documents and provided technical consultation and support for the project. The spreadsheets contained simple to complex calculations and formulae used to generate laboratory results and determine passing or failing criteria that directly impact patient health and product quality.
PROJECT SUCCESS
The project is currently ongoing, and the client is satisfied with PSC Biotech’s support and consultation for the project. The client has particularly mentioned PSC Biotech’s professionalism and technical knowledge.