1. Compliance Standards for Cleanroom & Pharmaceutical Industry
Lien Minh Hung inspection systems are engineered in strict compliance with premier international standards:
- GMP-WHO / EU-GMP: Stainless steel 304/316L contact surfaces, hygienic design, dust-free for cleanroom deployment.
- FDA 21 CFR Part 11: Role-based access control, comprehensive audit trail, tamper-proof electronic records and signatures.
- GAMP 5: Risk-based validation methodology for computerized automated manufacturing systems.
2. Turnkey Validation Dossier (IQ / OQ / PQ)
Every system commissioned by Lien Minh Hung is accompanied by full regulatory documentation:
- IQ (Installation Qualification): Installation protocols, mechanical drawings, electrical schematics, and component certifications.
- OQ (Operational Qualification): Functional testing protocols, alarm verification, emergency stop logic, and reject mechanism test sheets.
- PQ (Performance Qualification): Real-time production testing at maximum line speed with certified defect benchmark samples.
