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Life Sciences Solutions

Adhere to data validation, security and process integrity requirements mandated by the FDA, including 21 CFR Part 11.

Life Sciences Solutions Overview
     Advanced Lot Management
     Enhanced Security
     Audit Trails
     Electronic Signatures
     QA Extensions
     Validation Templates


QA Extensions

For Microsoft Dynamics GP customers, QA Extensions provides advanced functionality in the area of quality management, specifically in the areas of raw materials management and quarantine material control. QA Extensions operates seamlessly with Merit Solutions Audit Trails to retain records of quarantine material handling and proof of compliance with standard operating procedures.

Distinguishing Features

• Can specify a quarantine status for inventory.
• Enables hard locking of quarantine inventory from availability for use in other areas of the system, including production and order fulfillment.
• Can be configured to require quarantine material to pass quality specifications prior to release from quarantine status.
• Can be set to require dual password authorization prior to release from quarantine status.
• All changes and attempted changes are tracked in the Merit Solutions Audit Trails module, and are accessible via the SmartView audit viewer. Information tracked includes, but is not limited to, user, date and time, reason code, test results, dual password, and 'before change data' and 'after change data' values.
• Developed in the same technology and user interface as Dynamics GP.
• Enables compliance with FDA cGMPs, and adherence to FDA CFR 21 Part 11.

Conditional Release

QA Extensions provides increased control, including dual Password, Reason Codes and Reason Description for releasing materials from Quarantine status. All information is subsequently available within the Conditional Release Log and the Merit Solutions Audit Trails.

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Phone: (630) 614-7133
        
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