The Evolving Landscape of Pharmacovigilance IT: Key Considerations for the EU Regulation Amendment
The European Commission’s draft amendment to Implementing Regulation (EU) No 520/2012 introduces significant updates to pharmacovigilance requirements, with far-reaching implications for IT quality assurance in the pharmaceutical industry. These changes will extend well beyond computer system validation (CSV) to include data governance, data integrity, and comprehensive audit strategies. Full article here