Medical Device Link.

Originally Published EMDM May/June 2002

WEB WATCH

A program targeting US FDA–regulated industries features integration with MS Office

For most medical manufacturers, the challenge of keeping up with regulatory requirements can be summarized in one word: paper. From product development to clinical trials, the amount of paperwork that is traditionally involved in conceiving, producing, and marketing a medical device is daunting. Advances in computer software and the Internet promise to reduce the paperwork burden for OEMs, while simultaneously offering the benefits of increased traceability and time savings.

While paper won't disappear from compliance processes tomorrow, it is definitely on its way out. With US FDA's introduction of 21 CFR Part 11, medical device manufacturers now have the option of storing all of their compliance data for the US agency electronically. (For an introduction to 21 CFR Part 11, see www.devicelink.com/emdm/archive/01/05/005.html.) The advent of electronic recordkeeping has in turn prompted software firms to introduce systems that automate compliance management processes. Such systems are designed to be easier to use and more efficient than paper-based record systems.

One software supplier working in this area is EtQ Inc. (Farmingdale, NY, USA), which recently released version 1.6 of its Web browser-based quality management software, EtQ Solutions. The release contains two new features of interest to device manufacturers: full integration with Microsoft Office programs, and the capability to accept electronic signatures.

The company reports that its "Office Fusion" component makes its software the only compliance management program on the market that seamlessly integrates the Microsoft Office environment into a robust Web browser-based infrastructure. EtQ Office Fusion comes as a component that works within Microsoft Office and EtQ applications to bring the functionality of the two platforms together for both users and developers.

Linking with the Market Leader

"People work best with the tools they are used to working with," says Morgan Palmer, the company's chief technology officer. "Microsoft Office is the tool favoured by businesses worldwide for creating sophisticated documents, spreadsheets, and flowcharts." He adds that until now, manufacturers wishing to leverage the benefits of Microsoft Office in a controlled environment faced significant technical obstacles.

EtQ Solutions can integrate data between EtQ forms and MS Office files in formats such as Word, Excel, and Visio. This eliminates the need to manually synchronize fields in an MS Word document—such as revision level or effective date—with the corresponding fields in an EtQ form.

The program's "e-Sig" feature meets all of the requirements of 21 CFR Part 11, including electronic signature binding, audit trail, controlled access, and the comprehensive validation documentation required for the medical industry. "We are delighted to offer EtQ Solutions to the FDA-regulated world," says Glenn McCarty, CEO of EtQ Inc. "We know those companies are hungry for a completely customizable quality management package that doesn't require programming," he adds.

Most common quality management workflows and forms are provided with EtQ Solutions. Changes are easy to make because the forms and workflows are modular; authorized users can pick and choose forms or parts of forms and make changes by selecting options on a list. Furthermore, upgrades do not corrupt these customizations. Each module addresses a specific business need in accordance with FDA Standards for Quality.

The Advantage of Web-Based Software

Because EtQ Solutions runs on a Web browser-based system, it is easily integrated with any platform a company might be using, including an IBM Domino or Websphere-supported platform. Most users are already familiar with Web browsers and find EtQ Solutions to be immediately usable. A further advantage of the Web browser-based model of particular interest to device OEMs is that it eliminates the burden of client machine validation.

According to the company, current users of the program appreciate that EtQ Solutions does not require IT support or maintenance. As McCarty says, "The hassle-free back end and Web browser front end mean additional support costs are almost nonexistent, and the use of the IBM Domino platform ensures a totally secure, reliable, and scalable system."

EtQ is a leading developer of flexible software platforms and application suites that are designed to reduce the cost of achieving and maintaining compliance with quality and environmental management standards, as well as initiatives such as ISO 9000 and CGMP. The company's software platform enables users to configure, customize, and even create applications without programming.

A demonstration version of EtQ Solutions is available for download from the company's Web site, www.etq.com. Readers can also meet with the company on its stand #2461 at the Medical Design & Manufacturing East 2002 show in New York City on 4–6 June. For more information, contact EtQ Inc. at 399 Conklin St., Ste. 208, Farmingdale, NY 11735, USA; phone: +1 516 2930949; fax: +1 516 2930784; e-mail: sales@etq.com.

Copyright ©2002 European Medical Device Manufacturer