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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 |
|---|---|---|---|
| One or more processes for risk management in product realization have not been adequately documented. Collaborative Care Diagnostics, LLC. |
09 Feb 2026 | Normal | Justification: The overlooked software risks within risk documents indicate insufficient software lifecycle management. Excerpt: FMEA documents do not identify any risks associated with the software included with, and necessary for, correct intended operation of the products. View Details |
| A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated XL PRECISION TECHNOLOGIES LTD |
29 Aug 2025 | Normal | Justification: Inadequately documented software validation procedures impact quality system's reliability. Excerpt: You have not defined and documented written procedures for validation of all software utilized under the quality system. View Details |
| A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated XL PRECISION TECHNOLOGIES LTD |
29 Aug 2025 | Normal | Justification: Inadequately documented software validation procedures impact quality system's reliability. Excerpt: You have not defined and documented written procedures for validation of all software utilized under the quality system. View Details |
| Your firm failed to exercise appropriate controls for the electronic data acquisition systems Fujifilm Diosynth Biotechnologies Texas, LLC |
11 Mar 2025 | Normal | Justification: Inefficiencies in lifecycle management lead to lack of control over systems, affecting validation and data integrity. Excerpt: User privilege settings in allow your QC analysts to perform patch processing or manual processing for unsaved live data. View Details |
| Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established. Philips Medical Systems Nederland B.V. |
17 Jan 2025 | Normal | Justification: Software Lifecycle Management is implicated due to complaints linked to software coding issues not being escalated. Excerpt: Review of complaint data download shows 127 out of the 436 complaints with software defects were not escalated. View Details |
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