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Entegra Helps Clintrak Meet Audit Requirements

Published
  • July 01 2005, 1:00am EDT

Lumigent EntegraREVIEWER: Todd Jusas, vice president of technology for Clintrak Clinical Labeling Services.

BACKGROUND: Clintrak is the market leader in clinical trial labeling, producing 14 million labels for the clinical trials industry and serving 30 of the world's largest pharmaceutical firms.

PLATFORMS: Clintrak keeps data on a Microsoft SQL Server 2000 database to support finance, HR, Web-based operations, manufacturing and customer service. We use Dell servers running Windows 2000, NT and XP on Dell workstations.

PROBLEM SOLVED: Because labeling of investigational drugs is complex, there is a strict need for accuracy. Regulatory requirements such as the FDA's 21 CFR Part 11 and continuous audits by our pharmaceutical customers require comprehensive records of modifications to label content and a history of changes. We must have strong, tamperproof oversight mechanisms that are reliable and comprehensive to document any and all access to data, including access by privileged users. This information must be available to the pharmaceutical companies and government auditors in a concise way and must not consume enormous amounts of our staff time. We previously relied on an internally developed electronic audit process, but we needed a system that was more robust and foolproof. While replacing the previous system, we also wanted to speed up the audit process by improving access to information for auditors.

PRODUCT FUNCTIONALITY: Entegra from Lumigent Technologies provides comprehensive monitoring and auditing of data access and modifications. It offers an unimpeachable audit trail of who has accessed or modified what data. We rely on Entegra to track, analyze and report on data access activities. Specifically, it provides us with a detailed audit trail and record of who changed any data or database structure. These audit records meet the stringent audit requirements of the government and our pharmaceutical customers. We now have better visibility into our data and an accurate record of database changes - and we can detect these changes much faster. In addition, Entegra has improved the productivity of our IT staff who must oversee data auditing.

STRENGTHS: Entegra helps us meet our needs for compliance with regulations and protects the integrity of our corporate data assets. With Entegra, we can continuously monitor access to data and swiftly take corrective action when an intrusion into the database occurs. Before Entegra, we were not sure that we could detect all access and changes, and the audit process took much longer.

WEAKNESSES: I would have to say a weakness includes the interaction with the data from a reporting perspective. It would be nice to have more standard reports and/or forms to be able to view high volumes of information.

SELECTION CRITERIA: We found few options available for comprehensive database auditing other than those that relied on database triggers, which are a difficult way to implement an audit solution. Database triggers are costly, incomplete and introduce risk. They can degrade database performance, ignore database vulnerabilities and are difficult to manage and maintain.

DELIVERABLES: With Entegra, we produce comprehensive audit reports for our pharmaceutical customers and the FDA. These reports detail any and all access to our data records, providing information on data before and after alterations, who made the changes and when.

VENDOR SUPPORT: Customer support is one of the aspects that I like about Lumigent and Entegra. I became involved with the product when it was first introduced, and there were some issues. However, I contacted support and received fast response from very knowledgeable people who helped me.
    
DOCUMENTATION:
When I installed the product, I did not have any issues with the documentation. As always, I would like to see more in the way of how to use the product and help with how to pull information out of the repository.


Entegra
Lumigent Technologies, Inc.
289 Great Road
Acton, MA 01720
978-206-3700
www.lumigent.com


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