Data Integrity & Computerised System Validation

In 2005, a US generic manufacturer recalled every product it made after FDA investigators found failing results hidden in its chromatography data system. Data integrity failures still lead to warning letters, import alerts, rejected studies and suspended medicines today. This SkillCert Expert course teaches you to judge records the way inspectors do, and to prove that computerised systems are fit for their job. You will apply ALCOA+ to paper, electronic and hybrid records, tell raw data from metadata, recognise red flags and run a data integrity investigation. You will compare 21 CFR Part 11, EU GMP Annex 11 and the MHRA, PIC/S, WHO and FDA data integrity guidance, alongside India's revised Schedule M. You will then work through the GAMP 5 Second Edition validation lifecycle and computer software assurance (CSA), and learn to review audit trails, control access and change, and manage spreadsheets, cloud systems, AI tools, data migration and system retirement. The course is built for pharma QC and QA, clinical and testing laboratories, and contract research organisations in the UAE, the GCC and India. It includes 17 teaching videos, seven toolkit documents and 13 practice activities based on real workplace situations.

Data integrity is a frequent finding in FDA warning letters and in EU, PIC/S and WHO inspections, and India's revised Schedule M now expects validated computerised systems and data controls at every manufacturer. QA, QC, validation and laboratory professionals who can review audit trails, run risk-based validation and lead data integrity investigations are needed by pharmaceutical manufacturers, CROs, and clinical and testing laboratories across the UAE, the GCC and India.