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.
- EMA new guidelines on veterinary pharmacovigilance
- Veterinary product information templates
- MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system
- The FDA finalized its guidance on the form and content requirements for unique device identifiers (UDI)
- 4th Edition of the ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
- Fichas informativas com informação básica para todos os stakeholders sobre os novos Regulamentos dos Dispositivos Médicos e Dispositivos Médicos para o diagnóstico in vitro
- EXPAMED CECP (Opinion in the context of Cllinical Evaluation Consultation Procedure).
- EMA has published version 2.1 of the Implementation Guide for the ISO IDMP standards