Our remediation approach addresses the full data lifecycle—across systems, people, and processes—typically in three coordinated phases that can be adapted to any situation or environment.
Phase 1: Assessment & Risk Prioritization
-
Conduct data integrity gap assessments aligned with FDA, MHRA, and WHO expectations
-
Identify high-risk systems, records, and practices through risk-based triaging
-
Evaluate against ALCOA+ principles, 21 CFR Part 11, and applicable GxP requirements
Phase 2: Remediation Execution
-
Implement or enhance audit trails, access controls, backup validation, and data lifecycle procedures
-
Validate computerized systems (CSV) and ensure compliance with Part 11 or Annex 11
-
Redesign SOPs for documentation, review, and exception handling
-
Remediate legacy data where reliability cannot be verified
Phase 3: Culture & Sustainability
-
Train staff on data integrity principles and real-world expectations
-
Address behavioral contributors to non-compliance (e.g., shortcuts, record falsification)
-
Define monitoring metrics, routine audits, and continuous oversight to prevent recurrence
