CQV / Process Validation
With today’s growing regulatory bodies and ever-changing requirements, it’s important to have a partner who not only follows the newest guidelines and standards but has the resources to predict what’s coming down the pipeline.
AM Life Science is an owner-centric CQV partner with experience in change management and helping sites under consent decree rectify problems with the FDA by knowing what is required by regulatory bodies.
AM Life Science understands CQV execution thoroughly and focuses on forward planning to reduce roadblocks at later stages where things cost more. Utilizing a Validation Lifecycle approach, we author and implement:
In-process or finished-product inspection or testing is not enough to ensure product quality, safety, and effectiveness. The FDA requires process validation or documentation that a specific process will consistently produce a product that meets specifications and quality characteristics.
Process Validation (PV) involves multiple activities spanning the entire lifecycle of the product and process. Our expertise includes authoring and execution of PV documentation: