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LUNA Engineering Process-Validation-v1
LUNA process validation service for pharma/food/medical device, protocol writing/execution/report/regulatory support, FDA 2011/EU Annex 15/ICH Q10, FMEA.
Comprehensive validation for pharma, food, and medical devices.
Protocol writing, execution, and regulatory support included.
Conforms to FDA 2011, EU Annex 15, ICH Q10, with FMEA analysis.
| Scope | Process validation for pharma, food, medical device |
| Steps | Protocol writing, execution, report, regulatory submission support |
| Duration | 2-16 weeks |
| Risk tool | FMEA + critical process parameter mapping |
| Standards | FDA Process Validation Guidance 2011, EU Annex 15, ICH Q10 |