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Winchester launches the first compliance management toolset for Notes

(PRWEB) February 26, 2003

First Compliance Management Software that Enables Application Development for the Life Sciences Industry on the IBM Lotus Domino Platform

Critical Compliance Toolset Eases Migration to Lotus Domino 6

ORLANDO, Fla., January 27, 2003 – Winchester Business Systems, a leading provider of compliance management software applications for the pharmaceutical and medical device products industry, today announced ComPac GxP, the industry’s first compliance management toolset for the Lotus Domino platform designed exclusively to help regulated companies achieve compliance with the FDA Regulation 21 CFR Part 11, also known as “Part 11” compliance. Part 11 compliance is a stringent regulation enacted by the FDA that applies to all computer systems that create, modify, maintain, archive and retrieve electronic records required by the FDA for inspection and submission.

As the majority of pharmaceutical and medical device companies collaborate and share data leveraging the Lotus Domino platform, the ComPac GxP compliance management toolset represents a clear solution to the Part 11 compliance issue that leverages the Lotus Domino infrastructure and reduces the time customers spend migrating processes to achieve full compliance.

“‘Part 11’ is a serious issue on the minds of senior management at every major pharmaceutical and device company in the industry. It’s a costly, invasive and complex endeavor to ensure that every document that passes through a company’s Lotus Domino platform is compliant with the FDA’s requirements and to date, no software application developer has been able to do it – until now,” said Mike Regentz, president of Winchester Business Systems. “With the release of ComPac GxP, we are providing compliance with Part 11 in a single software toolset that literally ‘attaches’ to Lotus Domino. Non-compliance with Part 11 carries serious risks for these companies – it’s an issue that must be addressed when investing in technologies that are critical to day-to-day business operations.”

ComPac GxP: How it Works, Facilitates Compliance

ComPac GxP is a self-contained compliance management toolset that extends a company’s existing Lotus Domino applications. Once ComPac GxP is implemented, Lotus Domino applications can be made compliant with Part 11. ComPac GxP also provides an enhanced level of security, built-in business rules and best practices to simplify the compliance process. ComPac GxP, in conjunction with Winchester’s implementation and consulting services, enables customers to achieve a compliant environment. Key features that leverage the core functionality of Domino include:

·    Audit trail features that enable companies to track data through every stage of the information sharing and information flow process;

·    Authentication features, such as password control, challenge/response on save and expiration/renewal dates provide enhanced security;

·    Access logging for tracking database entry, document viewing and failed login attempts;

·    Access control to manage auditable access changes, such as levels, roles, ‘responsible for change’ assignments;

·    Digital signature capabilities, which are required in the medical products industry, include PKI based authentication, permanent storage in records and web or Lotus Domino authentication.

“One of the top priorities for our Life Sciences customers is Part 11 compliance,” added Ken Bisconti, vice president of messaging and advanced collaboration solutions for Lotus Software from IBM. “Winchester Business Systems has developed a compliance management toolset that leverages the Lotus Domino platform which has become critical in many organizations’ everyday operation. By working with Winchester, customers can develop applications that achieve compliance with Part 11 regulation.”

Regulation 21 CFR Part 11

The goal of Part 11 is to preserve the FDA’s ability to safeguard public health while providing regulated companies in the pharmaceutical, device, biological & food industries with the ability to create efficient paperless record-keeping and signing practices–including electronic and digital signatures. It governs electronic records created or modified since August 20, 1997. Non-compliance with Regulation 21 CFR Part 11 can result in serious penalties for these companies, including fines and even forced closure until compliance is achieved.

About Lotus Software from IBM

Lotus Software from IBM sets the standard for truly i`nnovative software and services that reflect the brand’s unique representation of the new ways individuals and businesses work together to achieve success. Lotus software is further redefining the concept of conducting business through practical knowledge management, e-business and other ground-breaking ways of connecting ideas, thinkers, buyers, sellers and communities around the world via the Internet. Lotus software is marketed in more than 80 countries worldwide through direct sales and extensive Business Partner channels.

About Winchester Business Systems

Headquartered in Woburn, Massachusetts, Winchester Business Systems is a leader in providing compliance management software applications and implementation services to Fortune 1000 companies worldwide. The Company delivers custom-tailored software and professional consulting based on the Lotus Domino and IBM e-business technology. For more information, please visit http://www.wbsnet.com.

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