Midrange Stuff, OS/400 Edition

SSA Global Technologies recently issued a new release of its flagship ERP system that features enhancements that will be beneficial to companies in the pharmaceutical and healthcare industries, among others. With BPCS Version 8.2, SSA GT is offering a new component called e-Signatures that will help companies regulated by the Food and Drug Administration come into compliance with regulations, commonly referred to as 21 CFR Part 11, which bring new auditing requirements for electronic records.

With 21 CFR Part 11, the FDA laid down a relatively simple rule for companies that deal with pharmaceuticals to follow, and that is to build the same level of accountability for electronic documents that they are required to have for paper-based documents. The change was made in response to the industry's increasing reliance on computers and digital documents to track the manufacturing and distribution of drugs, as opposed to the traditional paper-based system the industry has used for decades. In a worst-case scenario, the new rule ensures that an auditable trail of accountability will exist if, say, a bad batch of drugs has been sent out and its distribution was tracked electronically.

Although the FDA is not aggressively policing 21 CFR Part 11 at this point, there have been reports that the agency is ramping up enforcement with letters warning companies to comply or face steep fines. As enforcement tightens, drug manufacturers and distributors will need to comply--if not to protect consumers, then to protect themselves from the lawsuits that will surely ensue at the slightest sniff of negligence.

Because the FDA is not policing aggressively, pharmaceutical companies and their IT suppliers have, for the most part, taken a "wait and see" approach to compliance. Not so with SSA GT, which counts many of the world's biggest drug makers, including Baxter, Bristol-Myers Squibb, SmithKline Beecham, Eli Lilly, and Pharmacia, as BPCS clients.

SSA GT first started offering 21 CFR Part 11 remediation solutions in December 2001, when it partnered with data replication and high availability specialist DataMirror. The two companies worked to develop a solution called E-Record, based on DataMirror's LiveAudit software, which helped BPCS users to achieve compliance. DataMirror has used LiveAudit in a number of other 21 CFR Part 11 engagements with OS/400-based ERP systems, including Baan, CMS Manufacturing Systems, Intentia, MAPICS, J.D. Edwards, and PRISM, which is now owned by SSA GT.

With the release of BPCS 8.2, the Chicago company has made 21 CFR Part 11 compliance a native feature of the ERP suite through e-Signature, which simplifies the authorization processes required in a remediation project. When combined with e-Records, e-Signature enables BPCS users to be compliant with the 21 CFR Part 11, according to SSA GT.

In addition to the new capabilities for companies in the pharmaceutical industry, BPCS 8.2 includes additional enhancements that will benefit BPCS users in other industries. For example, BPCS 8.2 has the capability to view inventory in dual units of measure, which SSA GT says is essential to successful inventory management in the consumer packaged goods and food industries.

By providing more flexibility in scheduling and capacity loading, SSA GT is delivering enhancements for companies undertaking lean manufacturing strategies with BPCS 8.2. This release also includes enhancements geared toward new Seiban manufacturing and control strategies, SSA GT says, including the capability for organizations to link all customer project information together for better overall tracking, planning, and control.

In other SSA GT news, the company recently announced it has reorganized its global solutions management group to accommodate the acquisitions of Infinium and Computer Associates' interBiz business unit in the last year. The company also announced that Cory Eaves, who came over in the Infinium acquisition, has been promoted to head the reorganized group as vice president of global solutions management and solutions research. "We have restructured the solutions management organization into focused industry and product family groups to ensure that we will be better connected to customer needs and specific industry requirements," said Graeme Cooksley, executive vice president of sales and marketing. Eaves will report to Cooksley, who in turn reports to president and CEO Michael Greenough, and will be in charge of SSA GT's industry managers who focus on specific vertical markets. Eaves will also oversee functional product experts in supply chain management, customer relationship management, financial applications, business intelligence, human resources applications, and technology infrastructure products.