GMP Compliance Services
Regulatory Support for Pharmaceutical & Healthcare
We help pharmaceutical, biotech, and healthcare facilities meet stringent regulatory requirements with our GMP-compliant measurement solutions and documentation services.
Compliance Standards Supported
FDA 21 CFR Part 211
Current Good Manufacturing Practice
Current Good Manufacturing Practice
FDA 21 CFR Part 11
Electronic Records & Signatures
Electronic Records & Signatures
EU GMP Annex 1
Sterile Medicinal Products
Sterile Medicinal Products
WHO GMP Guidelines
International Standards
International Standards
ISO 14644
Cleanroom Classification
Cleanroom Classification
USP <797> / <800>
Pharmaceutical Compounding
Pharmaceutical Compounding
GMP Services
Qualification Documentation
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Design Qualification (DQ)
Validation Support
- Measurement system validation
- Calibration validation protocols
- Risk assessment documentation
- Deviation and CAPA support