Validation documentation requirements exist for fabricators, packagers, labelers, testers, importers and distributors of regulated products. They must validate their systems or risk audit findings and possibly the loss of an Establishment Licence or FDA approval.

Inspectors will evaluate at the importer’s site evidence of validation studies related to cleaning validation studies, test method validation, process validation plans and/or data and evidence of meeting labelled storage conditions (mapping and validation).

  • Write a Validation Master Plan
  • Develop and execute Protocols
  • Write the final reports.
  • Analytical Method Validation
  • Cleaning Validation
  • Equipment Validation (IQ, OQ, PQ)
  • Temperature mapping: Storage Areas, Cooler, Freezers, Incubators (Stability Chambers), Shipping Containers
  • Transportation Vehicles: Carriers, Shipping Routes
  • Process Validation
  • Facility Validation (utilities, HVAC, water)
Q&R Canada, Canada Compliance, Product regulatory, Health Canada, Medical equipment

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