Glossary
Access Control
Physical and logical controls that restrict computerised systems and data so that only authorised people can use the functions they are permitted to use.
Source · EudraLex Volume 4, Annex 11 (2011), §12 Security
Details
Access control ties each user's identity to their job authority so that unauthorised entry, change, or deletion is prevented and traceable. Inspections commonly cite shared accounts, excessive administrator rights, accounts of departed staff left active, and the absence of periodic privilege reviews or change records. Look at the user and role list, records of approval, change, and revocation, login and audit trail data, administrator activity, and periodic privilege reviews.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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As critical deficiencies were identified: • Inoperability of the production area and lack of access control to quality control/production, namely: - Inoperability of the production area, which was under renovation, without any equipment inside, without any communication to the Competent Authority.
EMA · EU GMP NCR (EudraGMDP) · 2026-07-13 -
Your 2018 Process Equipment Assessment Report identified numerous gaps and deficiencies for electronic manufacturing equipment needing upgrades in access controls, audit trails, saving electronic data and preventing clock alterations.
FDA · FDA Warning Letter · 2023-08-01
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EudraLex Volume 4, Annex 11 (2011), §12 SecurityGRM Regulatory Glossary
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