Regulatory compliance is not optional in pharma and biotech — it is the foundation of trust. Our GxP Compliance practice ensures your computer systems meet global regulatory standards including 21 CFR Part 11, EU Annex 11, and GAMP 5.
01.
Computer System Validation (CSV)
02.
21 CFR Part 11 Compliance Assessments
03.
EU Annex 11 Requirements Implementation
04.
Data Integrity & Audit Readiness Programs
05.
SOPs, Documentation & IT Policy Creation
06.
GAMP 5 Framework Implementation
