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Data Integrity
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| I observed on 11/18/2024 an alert message displayed on HPLC ID #QC-400 Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: The observation highlights data integrity issues due to improper alert management in laboratory software systems. Excerpt: the software audit trail (Empower 3.6.1) does not capture when the alert was acknowledged. View Details |
| Appropriate controls are not exercised over computers or related systems to assure... Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Data integrity is compromised due to lack of traceability and improper user account management as shown by software control issues. Excerpt: Appropriate controls are not exercised...you did not record actual name of users for traceability... View Details |
| Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records are instituted by authorized personnel. Biocon Sdn Bhd |
27 Sep 2024 | Normal | Justification: Data integrity is compromised due to shared logins, which fail to restrict unauthorized changes and ensure data traceability. Excerpt: Changes made by engineers during filling operators to PLC parameters are not attributable; analytical balance weight sheets not attributable. View Details |
| Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards. RC Outsourcing, LLC |
27 Sep 2024 | Normal | Justification: Data integrity is compromised by raw EM data being alterable without oversight, highlighting a need for robust data management. Excerpt: All EM raw data are recorded in an Excel sheet without a secondary review process in place. View Details |
| The responsibilities and procedures applicable to the quality control unit are not Granules India Limited |
06 Sep 2024 | Normal | Justification: Data Integrity is directly impacted through unauthorized disposal of GMP documents, violating key principles. Excerpt: lack of Quality Unit oversight... among multiple sections violated by destroying GMP documents, section 5.1.4 of SOP No.: GIL-CQA-012... View Details |
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