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Computer System Validation
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Appropriate controls are not exercised over computers or related systems Zydus Lifesciences Limited |
23 Apr 2024 | Normal | Justification: The validation process ensures that computer systems operate correctly and produce accurate, reliable output. This observation points to deficiencies in the system’s validation regarding data integrity and operational reliability. Excerpt: The software is not configured with an autosave function, allowing analysts to make changes to entry before manually saving without committing the changes to the audit trail. View Details |
| Computer systems are not maintained within an appropriate state. Amphastar Pharmaceuticals, Inc. |
01 Mar 2024 | Normal | Justification: The failure to validate spreadsheets directly impacts the reliability and accuracy of test results and product quality. Excerpt: Excel spreadsheets used to perform assay and impurity calculations were not validated to ensure accuracy of the test results obtained. 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. Jiangsu Hengrui Pharmaceuticals Co., Ltd |
16 Jan 2024 | Normal | Justification: The compliance of computerized systems to 21 CFR part 11 is crucial in maintaining data integrity and ensuring that only authorized personnel can make changes. Excerpt: Your firm's GMP related computerized systems and equipment spread across manufacturing workshops are not 21 CFR part 11 compliant. View Details |
| Input to and output from the computer and records or data are not checked for accuracy Eugia US Manufacturing LLC |
22 Dec 2023 | Normal | Justification: The issues related to unexpected data appearance indicate deficiencies in the validation of the NetSCADA system. Excerpt: It is unclear how this data were acquired in this system and whether or not there are controls in place to avoid the addition or deletion of data. View Details |
| Your firm has not established adequate procedural controls to protect the electronic data acquisition and manufacturing control systems used for DS manufacturing in Building at the AGC Biologics Bothell facility. AGC Biologics Inc. |
10 Feb 2023 | Normal | Justification: Computer system validation is crucial for ensuring systems operate as intended and data integrity is maintained. Excerpt: The computerized system used to control and collect process data from a SoloVPE and other systems have not been validated. View Details |
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