Module 12 Presentations

Data Integrity

From WHO Technical Report Series No. 996: • Increased observations made regarding good data and record management practices (GDRP) during inspections: • Good manufacturing practice (GMP) • Good clinical practice (GCP) • Good laboratory practice (GLP) regarding data reliability are undoubtedly multifactorial • FDA 21 CFR Part 11 was introduced to ensure data traceability and integrity for electronic records and signatures. All systems used for collecting data during a trial need to comply with this rule

The Organisation for Professionals in Regulatory Affairs