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Data Integrity and Compliance With Drug CGMP

FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement  meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.

Data Integrity and Compliance With Drug CGMP .Questions and Answers Guidance for Industry

News & Trends

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Recentes

  • Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing
  • New CTIS Guidance for Sponsors- Version 6.0
  • Real-world evidence framework to support EU regulatory decision-making
  • Implementing Decision (EU) 2025/1324, amending Decision (EU) 2019/1396, introducing changes to the governance and scope of expert panels under the Medical Devices Regulation (EU) 2017/745 and IVDR (EU) 2017/746.
  • The new version of EUDAMED 2.15.0 has been deployed.
  • Strategy to position the EU as the world’s most attractive place for life sciences by 2030
  • New version released – TEAM NB Code of conduct for Notified Bodies
  • 3rd progress report on the use of real-world evidence (RWE) in medicines regulation (February 2024 – February 2025)

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