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Home
About Us
About Us
Company
Team
Testimony
Leadership
Services
Services
Validation
Regulatiory Compliance
Commissioning(Cx)
CSV / Automation
503B Compounding Pharmacies
Thermal Mapping
Calibration & Certification
IT / Information Systems
Projects
News
Regulations
Contact Us
Regulations
• 21 CFR Part 11 – Electronic Records / Electronic Signatures / Data Integrity
• 21 CFR Part 211 - cGMPs
• 21 CFR Part 820 – Medical Devices
• 21 CFR Part 1271 - Human cells, tissues, or cellular or tissue-based products
• 21 CFR Part 111 – Nutraceuticals
• 21 CFR Part 58 - GLPs
• 21 CFR 610.12 – Sterility Testing for Biologics
• USP <797> - Pharmaceutical Compounding
• Eudralex Good Manufacturing Practices (GMP)
• ISO 14644 – Clean Room Classifications
• STM E2500 – Commissioning and Qualification (Validation)
• ISPE Baseline guides
• GAMP 5 (Good Automated Manufacturing Practices)