Microbiology FDA 483 (Zydus Lifesciences): Appropriate controls are not exercised over computers or related systems
Observation
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Firm / Company
Zydus Lifesciences Ltd.
System
Details
The MODA software system is used for microbiology documentation of sampling and testing for the *** system *** and environmental monitoring. The system is intended to be integrated with a barcode scanner to populate sample locations, sample information, and time and date information. Analysts are permitted to oven-ide the use of the scanner and make manual entries. 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.
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Audit Duration (Days)
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FDA 483 relevant to Microbiology
Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.