Validation Services

Assurance of Quality, Cost Reduction & Government Regulation Abeyance

Turn Key MDR2017/ISO13485 compliant Validation Services

  • All documentation including Project SOPs, Manufacturing Work Instructions, Validation Master Plans, Qualification Protocols & Completion reports, Design Change dossier (if any), short forms for analytical studies etc.

  • Complete printed out and signed package provided upon completion of the project/validation for internal record keeping and audit readiness.

KEY BENEFITS

  • 21 CFR Part 11 Compliance

  • Assured & Documented Product Reliability

  • Process Variables & Acceptance Limits determined & verified

  • Documented risks associated with current processes

  • Risk of non-conformance with Regulations reduces exponentially

  • Project team can focus on execution rather than documentation.

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