TetraScience employs a comprehensive, 3 pillared approach to regulatory compliance—adhering to essential industry guidance and standards, including:
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Good Automated Manufacturing Practices (GAMP 5 2nd edition)
- Food and Drug Administration (FDA) 21 CFR Part 11
- FDA Computer Software Assurance (CSA) Guidance
- EU Annex 11
Learn how TetraScience can accelerate your journey to quality and compliance by:
- Reducing validation effort by 80%
- Increasing ROI by 2-3x
- Slashing deployment time by two-thirds
- Simplifying change management
