Unlocking the nuances between Commissioning, Qualification, and Validation is pivotal for precisely navigating regulated industries. Commissioning initiates the process,…
The Commissioning, Qualification, and Validation (CQV) whitepaper presents a strategic approach to ensuring systems, processes, and equipment integrity and…
As the life science industries continue to evolve, the emphasis on regulation, safety, and efficiency is more pronounced than…
When a customer is purchasing new factory equipment, it is important to verify it is rigorously evaluated before it is delivered to their site. Factory Acceptance Test (FAT)…
This client utilizes PSC® Biotech’s professional services group to perform Gap Assessment on Cleaning Validation on their manufacturing equipment to maintain regulatory compliance and expectations. PSC® validation engineers evaluated the appropriate records, performed a gap analysis, and identified areas for continuous improvement.
The client engaged PSC™ to initiate the validation and qualification of a AQUATHERM SWS sterilizer (Syntegon) with a chamber of approximately 2500 ft3. Laboratory and Pharmaceutical Manufacturing equipment validations play a vital role to ensure the quality and effectiveness of the equipment being used for the development of manufactured products.
