3M Updates Packaging Tool for 21 CFR Part 11 Compliance

Adds capabilities to ensure integrity of electronic records to Web-based solution

Adds capabilities to ensure integrity of electronic records to Web-based solution

St. Paul, MN — April 13, 2004 — 3M this week rolled out the latest version of its Integrated Packaging Tool, adding capabilities to enable the integrity of electronic records to facilitate adherence to compliance recommendations of the U.S. Food and Drug Administration (FDA) related to 21 CFR Part 11 for companies in the pharmaceutical, medical device, and medical supply industries.

The Integrated Packaging Tool (IPT) is a Web-based system that centralizes and integrates structural, textual and graphical packaging data, including disparate databases, artwork, business rules and equipment, with event-driven workflow.

The IPT was originally developed internally by 3M to resolve its own complex packaging challenges — 3M actively manages over 150,000 packaging SKUs and manufactures more than 50,000 products in more than 70 manufacturing locations worldwide.

The solution provider is casting the new version of the Integrated Packaging Tool, version 4.05, as a significant upgrade to its centralized, Web-based application, with the capabilities needed to meet 21 CFR Part 11 requirements for electronic record management.

Although there is much discussion concerning how companies will be able to certify compliance with 21 CFR Part 11, 3M believes that an enterprise's packaging information management system should provide time-stamped audit trails, record retrieval, system security and electronic signatures.

"The intent of CFR Part 11 is to ensure data integrity, by setting minimum standards for accuracy, trustworthiness and reliability of records," said Nancy Alcorn, business process consultant with 3M Industrial Services and Solutions Division. "Computerized systems should provide the same degree of confidence as paper systems. The ability to store and retrieve ever-growing quantities of e-data is a challenge for most companies and should be an integral component of any comprehensive CFR Part 11 compliance plan."

Besides the new capabilities around records integrity, other additions to the software's functionality include field level controls (e.g., drop down menus, masked data and concatenated fields), event-driven workflow, Web-based drag and drop, additional standard reports, an upgraded user interface and the integration of 3M's Smart Device Manager component.

The Smart Device Manager extends printing capabilities to the manufacturing or distribution floor, while still enabling centralized management of packaging data and artwork, according to 3M. Smart Device Manager supports bi-directional communication with a variety of devices, enables simultaneous printing to multiple printers and gives users a single console view of all device activity within a workgroup, facility or enterprise, the provider said.

The software also allows reconciliation of all print jobs, which for life sciences companies is critically important for purposes of quality control and compliance.