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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 |
|---|---|---|---|
| Your firm failed to exercise controls over computerized manufacturing equipment Strides Pharma Science Ltd. |
20 May 2026 | Normal | Justification: Improper user access controls allow unauthorized recipe management, undermining system integrity. Excerpt: Recipe creation should be restricted to Quality Assurance personnel. View Details |
| Appropriate controls are not exercised over computers or related systems Allure Labs, LLC |
27 Mar 2026 | Normal | Justification: Compromised access control due to multiple accounts with elevated privileges, heightening the risk of unauthorized data modifications. Excerpt: QC Manager has two HPLC (b)(4) user accounts, one as "system", and the other as "administrator". 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 Cerovene Inc. |
23 Mar 2026 | Normal | Justification: Shared credentials and system access without authentication point to failures in user access control. Excerpt: The QC Manager was able to change the date and time from the balance without log-in credentials. View Details |
| Failure to ensure the study is conducted in accordance with the protocol and/or investigational plan Abbisko Therapeutics Co., Ltd. |
20 Mar 2026 | Normal | Justification: User Access and Controls is fundamental because improper role settings allowed unauthorized access, impacting data integrity. Excerpt: This vendor made an error while updating permissions for user roles for the study which granted the blinded PV staff access. 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. Aurobindo Pharma Limited, Unit VII |
10 Feb 2026 | Normal | Justification: Shared credentials and excessive permissions illustrate a lack of controlled user access management. Excerpt: The computer system has a shared username and password for the department. View Details |
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