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.

• 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.