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Data Integrity Frequently Asked Questions (FAQ)

This document contains a collection of frequently asked questions that have been submitted by the
industry to the DI taskforce. The intention of this documents is that this is a living document that will
be updated as new questions are opposed to the group

News & Trends

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Recentes

  • Health Technology Assessment: HTA 2025 Annual Report
  • Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form
  • New Eurachem Guide to Quality in Analytical Chemistry Released – 4th Edition (2026)
  • Harmonised ICH M15 Guideline, General Principles for Model-informed Drug Development, Adopted
  • Computer Software Assurance for Production and Quality Management System Software
  • FDA CDER – 2025 New Drug Therapy Approvals: key takeaways
  • The MDSAP Audit Approach (MDSAP AU P0002.010) was just revised
  • FDA Clinical Decision Support Software

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