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Audit Trails

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
      Validation Templates


Audit Trails

Audit Trails provides Microsoft Dynamics GP customers with track, trace and reporting capabilities for any changes associated with any data in Microsoft Dynamics GP, and for any data in third-party software or customized software resident within Dynamics GP. This includes information related to a change; such as time, date, and user; as well as the 'before data' and 'after data' values associated with a change. The Audit Trails modules for Dynamics GP Versions 8.0 and 9.0 are available directly from Microsoft; modules for Dynamics GP Version 7.5 are available from Merit Solutions.

Audit Trails is easily configured for tracking just the data required for each customer, and is designed for efficient but controlled ongoing maintenance and administration.

But what really sets Audit Trails apart is that it is developed completely within Microsoft Dynamics GP, including the same user interface. This allows for easy adoption by your customers, and ensures technical stability and ongoing compatibility.

Audit Trails gives you an easy to use, complete track and trace capability using SmartView, a SmartList-like user interface to the audit database.

The software can operate with the closed-looped controls, or as a 'closed system,' as required by many companies when using an Audit Trails system.

Using Audit Trails, Life Sciences companies can adhere to the stringent data validation, security and process integrity requirements mandated by the Food and Drug Administration (FDA), including those requirements specified in regulation 21 CFR Part 11.

Distinguishing Features

• Can track data for all transactions and all tables within Dynamics GP or internally resident customizations or third-party software.
• Is able to be configured to track just the transactions and data deemed significant by the customer, contributing to ease of maintenance and the lowest impact on hardware performance and database size.
• Developed in the same technology and user interface as Dynamics GP.
• The SmartView audit viewer is a SmartList-like access option for the audit tables. This gives fast and easy access to any audit information, including the ability to narrow the data views down based on multiple sort criteria.
• Enables adherence to FDA CFR 21 Part 11, including before and after transaction data values, and operation as a 'closed system.'

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Resources:

Microsoft Audit Trails Datasheet

Protect Corporate Value with Audit Trails and Electronic Signatures for Microsoft Dynamics GP.

Audit Trails Manual