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Data & Technology

Computer System Validation & Data Integrity

Risk-based validation of GxP systems, including 21 CFR Part 11 and EU Annex 11 assessments.

What's Included

  • Validation of GxP systems: EDC, safety database, eTMF, IRT, LIMS, serialization
  • Validation plans, URS, FS/CS, risk assessments, IQ/OQ/PQ, validation summary reports
  • GAMP 5 risk-based approach
  • 21 CFR Part 11 and EU Annex 11 compliance assessments
  • SaaS and cloud vendor qualification
  • Data integrity assessments (ALCOA+)
  • Periodic review, change control and decommissioning
  • Audit trail review programs

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