Ensuring Data Integrity & Equipment Qualification per 21 CFR Part 11
Common Challenges in Data Integrity 1. Deletion of Audit Trails During recent qualification efforts for a depth filtration skid…
Equipment Validation: A Comprehensive Overview
The pharmaceutical industry involves various steps and procedures in drug manufacturing—from formulation to packing finished products. Different equipment is…
Blog | Commissioning | CQV | Qualification | Validation
The difference between Commissioning, Qualification and validation
Unlocking the nuances between Commissioning, Qualification, and Validation is pivotal for precisely navigating regulated industries. Commissioning initiates the process,…
Elevating Cell and Gene Therapies – The Latest in Validation Innovation
Elevating Cell and Gene Therapies – The Latest in Validation Innovation, our comprehensive whitepaper designed to illuminate the forefront…
Commissioning of the new manufacturing science and technology (MSAT) lab.
PSC Biotech experts were assigned to commission the architectural finish and mechanical completion of the Manufacturing Science and Technology (MSAT) Laboratory. The commissioning took place parallel with the final construction process. This helped our CQV experts to directly start and complete the project.
Commissioning Of The New Apheresis Inspection And Processing Spaces
The commissioning team successfully completed the modifications to the air handling system according to the client’s specifications and design. They checked the changes to the supply and return ductwork, as well as the new and existing variable air volume boxes.
