For WHO GMP, FDA 21 CFR Part 11, EU GMP Annex 15, and similar regulatory frameworks, you need a comprehensive validation package. HIJ provides:
Design Qualification (DQ)
Proves the equipment design meets your URS and regulatory requirements
Installation Qualification (IQ)
Verifies correct installation, utilities, and environmental conditions
Operational Qualification (OQ)
Tests all operational parameters against specifications (e.g., sealing force, temperature)
Performance Qualification (PQ)
Demonstrates consistent performance with your actual product over multiple runs
Additional Critical Documentation:
- 21 CFR Part 11 Compliance Report: Electronic signature validation, audit trail integrity, data encryption protocols
- Material Certificates: Mill certificates for all contact parts (typically 316L stainless steel)
- Calibration Certificates: For all sensors, gauges, and measuring instruments (traceable to NIST or equivalent)
- Software Validation (if applicable): For HMI, SCADA, or MES integration
- Cleaning Validation Protocol: To prove effective cleaning between product changeovers
HIJ Compliance Guarantee: We provide all protocols, test scripts, and final reports in editable format. If an auditor requests additional documentation, we'll generate it at no extra charge.
Download sample DQ/IQ/OQ package →