• Home
  • About Us
    • Company
    • Team
    • Testimony
    • Leadership
  • Services
    • Validation
    • Regulatiory Compliance
    • Commissioning(Cx)
    • CSV / Automation
    • 503B Compounding Pharmacies
    • Thermal Mapping
    • Calibration & Certification
    • IT / Information Systems
  • Projects
  • News
  • Regulations
  • Contact Us
  • Home
  • About Us
    • Company
    • Team
    • Testimony
    • Leadership
  • 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)