IBM Launches Solution to Enable Cost-Effective Regulatory Compliance and Operational Flexibility

IBM Regulatory Compliance Solution Offers Pharmaceutical Biotechnology and Medical Device Companies Tools to Get Safer Drugs and Devices to Market Faster

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SOMERS, NY - 20 Oct 2004: IBM today announced IBM Solution for Compliance in a Regulated Environment (SCORE), a new regulatory compliance solution intended to make it easier and more cost-effective for pharmaceutical, biotechnology, and medical device companies to comply with regulatory mandates for R&D, manufacturing, and sales and marketing processes.

With the FDA and the European Medicines Evaluation Agency (EMEA) and Japanese Ministry of Health, Labour and Welfare bringing renewed focus to business processes and scientific principles, organizations need to ensure consistent and accurate tracking of content across their business processes. To meet these increasing regulatory needs, IBM has built a compliance solution that unites document and data management with the necessary additional functionality of application integration, business process management, and collaboration, allowing for the connection and flow of information, both data and documents, through regulated processes across the entire product life-cycle, from R&D to manufacturing to sales and marketing.

"As the biopharmaceutical industry moves toward more specialized products for targeted treatment, it must operate with flexibility, while at the same time maintain a rigorous monitoring system necessary to ensure product quality and compliance with increasing regulatory oversight," said Dr. Carol Kovac, General Manager of IBM Healthcare and Life Sciences. "This new solution offers our customers an effective way to increase operational flexibility across their operations in R&D, manufacturing, and sales, as well as a means to monitor and track their data and documentation through numerous process and systems. The end result will be reduced process variability, increased product quality, and reduced regulatory risk."

The capabilities of IBM SCORE are intended to give companies the ability to assemble submissions faster and reduce cycle-time for trials, to analyze and correct manufacturing batch data faster, to distribute regulated marketing literature to field sales teams faster, while helping maintain compliance with 21 CFR part 11 and the new cGMP's.

IBM SCORE is the next generation of IBM regulatory compliance solutions for the life sciences industry, providing document lifecycle management, application integration, business process management and collaboration. The solution is built using proven IBM software technologies and includes a detailed validation and system documentation package and tools for accelerating the implementation of a regulatory submission process. It can also integrate with third-party software. IBM SCORE is delivered through IBM Business Consulting Services.

"Pharmaceutical companies face tremendous document challenges in bringing drugs to market. The drug approval processes requires information and data from a variety of sources and applications; from records of clinical trials to electrocardiographs," said Eugene Lee, vice president, Product Marketing, Intelligent Documents Business Unit, Adobe. IBM SCORE, together with Adobe's intelligent document technologies will make it easier and more cost-effective for our mutual customers to assemble, track, and reuse submissions within the drug approval process."

IBM SCORE is part of IBM's overall regulatory compliance offering that includes strategy and change and compliance consulting practices along with solutions such as the IBM Corporate Information Asset Manager that helps organizations with managing long-term archive and retrieval.

IBM SCORE can support beta customers today and is anticipated to be available early in the first quarter of 2005.

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