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Data Backup and Recovery
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Failure to maintain a backup file of data entered into the computer or related system Eugia SEZ Private Limited |
29 Feb 2024 | Normal | Justification: The observation directly mentions a failure to maintain backup files for critical data, specifically noting that current practices lack function to save data internally or via backup. Excerpt: Failure to maintain a backup file of data entered into the computer or related system. View Details |
| You failed to maintain a backup file of data entered into the computer or related system. Shilpa Medicare Limited |
09 Nov 2023 | Normal | Justification: The issue stems from a failure to properly execute and ensure robust data backup and recovery processes, leading to significant data loss. Excerpt: "Your procedure, SMLJ/ITD/SOP-GEN/002-01 Back up, Restore, Verification and Archival of Electronic Data ... does not ensure that the complete data from your standalone laboratory equipment are backed up securely." View Details |
| Failure to maintain a backup file of data entered into the computer or related system. FUJINOMIYA FACTORY OF TERUMO CORP |
19 May 2023 | Normal | Justification: Backup and recovery processes are directly related to ensuring data availability and integrity. Excerpt: Data from the (b) (4) (b) (4) utilized in testing of product prepared in (b) (4) (b) (4) and (b) (4) located in the (b) (4) are not backed up. View Details |
| Backup data is not assured as complete and secure TERUMO YAMAGUCHI CORPORATION |
30 Mar 2023 | Normal | Justification: The observation explicitly identifies issues related to backup data integrity and protection during power disruptions. Excerpt: Backup data is not assured as complete and secure from alteration, erasure or loss... 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: Validating backup and recovery processes ensures data remains accessible and intact after any disruption. Excerpt: Audit trails enabled in the data acquisition system are not reviewed for each data set during the lot review process. View Details |
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