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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 |
|---|---|---|---|
| (b) (4) are not checked for accuracy. ARUP Laboratories, Inc. |
06 Nov 2024 | Normal | Justification: Issues arose from poor lifecycle management practices, failing to incorporate adequate testing and validation phases. Excerpt: Your firm failed to adequately test the (b) (4) of your new (b) (4) related to your (b) (4). View Details |
| Failure to validate software used as part of production, quality system, and service as required by 21 CFR 820.70(i) ABC Pharmaceuticals Inc. |
25 Nov 2023 | Normal | Justification: The observation specifically mentions the failure to validate software, directly implicating software lifecycle management processes. Excerpt: Specifically, the software used for production scheduling and inventory management (version 3.2) has not been validated. View Details |
| Your firm failed to adequately validate software used as part of production or the quality system ABC Pharmaceuticals |
15 Oct 2023 | Normal | Justification: Software Lifecycle Management is directly affected as the observation relates to validation protocols, a critical component of managing software throughout its lifecycle. Excerpt: Your firm failed to adequately validate software...for its intended use according to an established protocol. View Details |
| Your firm failed to adequately validate the design and release of changes to software used as part of production and the quality system. ABC Pharmaceuticals Inc. |
01 Oct 2023 | Normal | Justification: Software Lifecycle Management requires that all software updates are validated to verify they meet user needs and intended use. Excerpt: update to version 2.3 on 01/15/2023 without performing a design validation to ensure ... View Details |
| Failure to establish and maintain procedures for changes to a specification ACME Pharmaceuticals Inc. |
01 Oct 2023 | Normal | Justification: Software lifecycle management is impacted as the failure pertains to software changes without procedural integration. Excerpt: No documented procedures for implementing changes to the software of the automated production line. View Details |
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