Vihan Engineering Pvt. Ltd.
Validation Services
Assurance of Quality, Cost Reduction & Government Regulation Abeyance
Turn Key MDR2017/ISO13485 compliant Validation Services
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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.
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Complete printed out and signed package provided upon completion of the project/validation for internal record keeping and audit readiness.
KEY BENEFITS
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21 CFR Part 11 Compliance
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Assured & Documented Product Reliability
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Process Variables & Acceptance Limits determined & verified
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Documented risks associated with current processes
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Risk of non-conformance with Regulations reduces exponentially
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Project team can focus on execution rather than documentation.
