BioTeknica provides proven validation methodologies that have been successfully implemented for our clients at both small and large Medical Device and Pharmaceutical manufacturers.
Do all of your products, equipment, processes, software, and systems operate as designed and intended?
Inadequate validation is a common source of FDA 483 findings. Responding to them can be costly and disruptive, especially if it requires the validation of your legacy products, test methods, equipment, and processes. If just one validation segment doesn’t meet regulatory standards, it can negatively impact your organization. We enhance your future bottom line by characterizing, optimizing, and thoroughly validating your production processes and systems.