Validation Planning and Preparation

As the sayings goes ‘He who fails to plan, plans to fail’……

Validation Master Plan/ Qualification Plan forms the cornerstone of validation approach and serves as the principal document for regulatory inspection. It provides all parties a precise overview of their roles and responsibilities and aligns the execution methodology so that the validation process runs smoothly.

PSC Asia has experts from many different disciplines including Facility Engineering, Process Engineering, Microbiology and Quality Assurance with strong GMP, GLP, GAMP 5, ISO and 21 CFR Part 11 regulations knowledge. We understand your processes and expectations and can help you with the realistic planning of attainable validation goals.

We can identify and help you to eliminate repeated work using an integrated commissioning and validation risk based approach, to produce a comprehensive validation plan. We can supplement this with an extensive traceability matrix that allows you to demonstrate compliance and comprehensive testing, and that can also be used to support change through the life of the system. In addition, we can help you to ensure that all your validation lifecycle documents : supplier documents or protocols generated in-house are consistent with the Validation Master Plan/ Qualification Plan.

We offer fast documentation turnaround and our strength in depth allows us to execute fast track validation projects. With our extensive experience and protocol library, we are able to offer lower cost solutions which still remain compliant.