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