FDA-Regulated Companies Use Plateau's Proven Audit Trail, e-Signature Features to Meet 21 CFR Part 11 Requirements

Since 1997, Pharmaceutical and Medical Companies Have Used Plateau to Manage e-Learning in a Validated Environment; Trainers Cite Plateau's Strong Track Record on FDA Compliance

ARLINGTON, VIRGINIA August 23, 2001 Plateau Systems, a provider of enterprise software that manages learning and improves business processes for organizations, today announced that Plateau's security and audit-trail functions have been validated at several Global 2000 pharmaceutical and medical device companies subject to the Food and Drug Administration's rigorous guidelines on the acceptance of electronic records, known as 21 CFR Part 11. The regulations state the criteria for accuracy and security that the FDA will use to accept electronic records in lieu of paper documents.

Plateau's Learning Management System (LMS) is being used by more than a dozen pharmaceutical and medical device companies, and has been validated at ALZA Corp. (NYSE: AZA); Guidant Corp. (NYSE: GDT); Zimmer Inc. (NYSE: ZMH) and several others. Completing the software validation process, which involves an exhaustive series of function tests, is essential before going into any FDA or international ISO 9000 audit.

Because Plateau began adding 21 CFR Part 11 compliance tools to its LMS soon after the new regulations were announced in 1997, many of Plateau's FDA-regulated clients have already implemented features that help them through difficult audits, inspections and validation procedures. These features have also emerged as key assets in audits under ISO 9000 quality standards.

Plateau's LMS has been audit-friendly within the FDA space for several years, said Cathy Harnett, a learning associate with ALZA, which makes the drugs Concerta and Ditropan XL. They have always stayed current with the regulatory demands of our industry, which makes my job easier. Plateau's LMS is ahead of the curve that way, and so are we because we had Plateau.

Among the Plateau LMS functions that specifically address 21 CFR Part 11 are a comprehensive audit trail, which shows changes in an individual's training history as a series of unique, time-stamped events, and e-signatures secured by frequently updated PIN passwords for all training users. Auditors concerned with change control have also praised Plateau's configuration management features, which track revisions to all SOP training documents, automatically alerting affected staff that they must be retrained when a document in their qualifications profile is altered.

21 CFR Part 11, which the FDA has recently begun to enforce, focuses on auditable archives, security, e-signatures, time/date stamps and document change control. The regulations affect databases and software systems throughout medical manufacturing and R&D, including training platforms, because they are document-heavy and closely tied to quality control.

With dozens of customers in heavily regulated industries, Plateau has closely monitored emerging federal regulations and quality systems guidelines over the years, and consistently enhanced its LMS with tools designed to satisfy them. Even before the release of 21 CFR Part 11, Plateau LMS helped companies comply with Good Manufacturing Practices (GMP) for software and training systems that FDA auditors required.

Plateau has definitely helped Zimmer maintain compliance with FDA regulations. I'm confident, because Plateau understands FDA compliance issues even better than most of its customers, said Priscilla Hall, manager of regulatory education and training at Zimmer Inc., a leading global manufacturer of orthopedic implants. One reason pharmaceutical and medical device companies have favored Plateau is that revised SOP documents are traceable, a feature I haven't seen in any other LMS vendor.

Guidant Corp., which designs and develops cardiovascular medical devices, is expanding its use of Plateau LMS to deliver training company wide. This year Guidant will use Plateau LMS, which recently passed the company's ISO 9000 audit, for 10,000 students and 200 administrators at five locations.

When a student is assigned a qualification, Plateau checks their training history; if they don't have what's required, an email automatically goes to them and their supervisor, said Vicki Cloutier, a senior training associate at Guidant. It takes human error out of the equation.

Because 21 CFR Part 11 is particularly concerned with document security, Plateau's bulletproof safeguards have earned the confidence of compliance officers.

In the latest versions of Plateau, the training system's Web interface will not allow your e-signature and regular login to have the same password. That forces people to have a second layer of security, said ALZA's Harnett. The LMS is also integrated with our Oracle and human resources systems, so that when our employees change jobs within the company, their qualifications are automatically changed. It saves us a lot of data entry time.

About Plateau Systems: Plateau manages learning and knowledge processes for organizations, improving their business operations by integrating and delivering the knowledge employees, customers and partners require to excel. Plateau's enterprise-class software supports online and traditional learning methods, and integrates seamlessly with other enterprise software applications to enhance their value and reduce the cycle of learning. Plateau 4 Learning Management System (LMS) is built on open, J2EE/EJB architecture, and is being used by clients across the globe, including Motorola University, Federal Express, Nestle USA and the U.S. Air Force. The company was founded in 1996, and is headquartered in Arlington, Virginia.

###