Validation

As your businesses regulatory requirements increase, it becomes just as important to maintain validated systems and processes to protect your Establishment License and FDA approval. Many contract manufacturers and packagers have gained or lost business based on their ability to meet validation requirements. We can ensure your business does.

Q&C works systematically, within pre-determined time lines on any of the following projects:

  • The Validation Gap Analysis™
  • Validation Master Plans
  • Validation Project Plans
  • Equipment validation (IQ, OQ, PQ)
  • Temperature mapping
  • Autoclave Sterilization Studies
  • Process Validation
  • Shipping Validation
  • Facility Validation (utilities, HVAC, water)
  • Analytical Method Validation
  • Cleaning Validation

Recent Validations We've Completed