2 of 2 21 CFR Part 11 Jobs in London

platform’s next chapter - a Patient Registry solution, electronic data capture platform, and a validated ePRO library. Ship a regulatory‐grade product, considering e.g. 21 CFR Part 11 audit trails and eConsent with e‐signatures. Treat compliance as a design constraint to engineer around … ePRO/eCOA, eConsent, patient registry, or sensor‐based study platforms. Hands‐on experience shipping under GCP/ICH E6(R3), 21 CFR Part 11, and EU Annex 11, including computer system validation and audit‐ready release management. Working fluency in clinical data standards, especially ...

driven platform to help advance the treatment of neurological disorders and reduce the uncertainties associated with drug discovery, development and monitoring. As a key part of the global neurological disease research community, the Company has built a global reputation and 20-year track record … software development and validation policies and procedures, ensuring best practice for ‘security & privacy by design’ principles and in compliance with current GCP, FDA 21 CFR Part 11, EU Annex 11, GAMP, FDA QSR Part 820 (QMSR), EU MDR (Regulation 2017/ ...