Data Integrity Assurance

  • Data Integrity Policy, Procedures & Requirements
  • Risk Based Approach for Analysis of Systems & Processes
  • Prerequisite Checklists for Specific Areas
  • Distinct Investigation Framework for Root Cause of Analysis​(Laboratory & Manufacturing Areas)
  • Testing Procedures for Monitoring, Review & Verification
  • Best Practices for Electronic Records & Electronic Signatures (ERES) management
  • ​Best Practices for Audit Trail Review
  • Cost-efficient 21 CFR Part 11 & EU GMP Annex 11 Compliance Program
  • ERES Assessment & Remediation projects
  • 21 CFR Part 11 Inspection Readiness support
  • Generation, Execution, Review & Approval of Data Integrity related Protocols & Reports
  • Data Integrity Continuous Improvement Model (Best Practices for Paper and Electronic Records)
  • ​Data Integrity Compliance Training Program