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Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.
TITLE/ COMPANY | Issue Date | Status | Details |
---|---|---|---|
Appropriate controls are not exercised over computers or related systems Mylan Laboratories Limited (FDF-3) |
26 Jun 2024 | Normal | Justification: Unauthorized access and 'Auditing Breached' incidents are directly related to deficiencies in User Access and Controls. Excerpt: Your Quality Unit failed to identify and investigate... QA personnel appears to have "full" administration access. View Details |
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records Cipla Limited |
21 Jun 2024 | Normal | Justification: The observation points to inadequate control and assignment of user privileges, directly linking to User Access and Controls. Excerpt: User privileges assigned within the manufacturing equipment used for products intended for the US market are not appropriate for the job functions being performed nor are they adequately defined. View Details |
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Eugia US Manufacturing LLC |
22 Dec 2023 | Normal | Justification: The observation highlights weaknesses in user access management and the use of shared accounts, which are central to user access and control processes. Excerpt: Your firm’s NetSCADA software used to operate (b) (4) all users have access to a non-specific administrator-level account. View Details |
Your firm has not established adequate procedural controls over equipment systems to ensure data integrity and system access Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
14 Dec 2023 | Normal | Justification: pH meter without login control, PDA systems accessed by shared admin accounts, and lack of ACL generation are all access control failures. Excerpt: IT department is not able to generate access control list (ACL) for the PDA computer system used for DP manufacture operations... View Details |
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Carma Laboratories, Inc. |
14 Nov 2023 | Normal | Justification: The enabled deletion function and unauthorized access suggests a breakdown in user access control procedures. Excerpt: The delete functions are enabled in all your laboratory computer systems... View Details |
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