Packaging software meets FDA regulations

The package provides a secure, central repository for packaging graphics, text, templates and translations, and stores the specifications for individual customers, distributors, regulators and carriers around the world.

The new version (4.05) incorporates capabilities that enable the integrity of electronic records and facilitate adherence with 21 CFR Part 11, which is an important compliance issue for companies in the pharmaceutical, medical device and medical supply industries.

"The intent of 21 CFR Part 11 is to ensure data integrity, by setting minimum standards for accuracy, trustworthiness and reliability of records,"​ said 3M​'s Nancy Alcorn. Computersied systems should provide the same degree of confidence as paper systems under the rules, but the ability to store and retrieve ever-growing quantities of electronic data is a challenge for most companies trying to comply with the rules, she noted.

Although there is much discussion concerning how companies will be able to certify compliance with 21 CFR Part 11 - and the FDA is in the process of updating​ the legislation - 3M's viewpoint is that the packaging information management system should provide time-stamped audit trails, record retrieval, system security and electronic signatures, and the new package offers all these features.

Other key additions to the software's functionality include the integration of 3M's patent-pending Smart Device Manager component, which is designed to extend printing capabilities to the manufacturing or distribution floor, while still enabling centralised management of packaging data and artwork.

The SDM enables simultaneous printing to multiple printers and gives users a single console view of all device activity within a workgroup, facility or enterprise. It also stores and collates all print jobs, which for life sciences companies in particular is critically important for purposes of quality control and compliance.