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TITLE/ COMPANY | Issue Date | Status | Details |
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The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Nephron Sterile Compounding Center LLC |
10 Feb 2023 | Normal | Justification: Software Lifecycle Management is necessary to ensure any software used in the manufacturing processes is validated and maintained over time, preventing potential compliance issues. Excerpt: Ensure software validations and process validations are performed. View Details |