Leading Pharmaceutical Company Selects DSS' Auditron400 to Meet FDA 21 CFR Part 11 Compliance for AS400/ISERIES Databases

Business Wire, August 5, 2002

Business Editors/High-Tech Writers

POMPANO BEACH, Fla.--(BUSINESS WIRE)--Aug. 5, 2002

On July 21, 1999 the FDA announced the availability of a Compliance Policy Guide (CPG) section 160.850 entitled "Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures," an update to the CPG Manual August 1996 Edition.

According to the FDA, "Part 11 is intended to create criteria for electronic record keeping while preserving the agencies ability to protect and promote public health." It identifies technical and procedural requirements that all organizations regulated by the FDA must meet if they choose to maintain records electronically. In particular, Part 11 references the "use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records."

The agency stated that failure to comply with Part 11 will result in regulatory action against organizations practicing electronic record keeping.

Upon issuance of the final rulemaking by the FDA, Dynamic Systems Solutions, Inc. identified the opportunity to present its Auditron400 software line to organizations running the IBM AS400 and regulated by the FDA.

In November of 2001, an international pharmaceutical company that specializes in eye care products began working with Dynamic Systems Solutions, Inc. in the effort to comply with the FDA's Part 11 ruling.

The company installed and evaluated DSS' Auditron400 Software package, designed to track and report modifications made to any AS400 database at the Field Level. Among its features, the software logs the before and after image of data that has been changed, added or deleted as well as provides detailed information on the job performed, enabling the creation of a complete Data Audit Trail. After several weeks of testing, the organization selected the Auditron400 Software Package to establish Part 11 compliance of the file monitoring at their facilities. The decision was made for a global implementation that is set to begin 2nd quarter of 2002.

Dynamic Systems Solutions, Inc. also offers the Auditron400 Software with a JD Edwards interface, enabling organizations running the JD Edwards Software System to utilize the product for monitoring of files and fields over any AS400 database, while having the look and feel of the JD Edwards application.