FDA Regulations Lead Medical-Device Manufacturer To PLMFDA Regulations Lead Medical-Device Manufacturer To PLM

Among the requirements medical-device manufacturers must adhere to is a Food and Drug Administration regulation known as CFR 21 Part 11, for maintaining control over documents related to the development of its products. It's not alone in doing this--any industry regulated by the FDA has to do so.

But before the advent of product life-cycle management software, managing all the information relating to product design and master records, which include all the parts, bills of materials, operating procedures, drawings, and documents that relate to how a product is made, could cause a real headache. Hologic Inc., a manufacturer specializing in medical-imaging systems, primarily for women's health care such as digital mammography systems, has cured that with a dose of Agile Software Corp.'s PLM system. And it hopes that a version of the software that's coming out especially for its market will take any further edge off the pain.

In addition to managing all the information relating to its product design and master records, Hologic uses Agile's software to ensure automating and regulating the processes for all its engineering change orders. The latter relies on workflows and electronic signatures. Meeting those requirements in the paper world required a time-consuming process of somebody signing off on a change order, then forwarding that to someone else for that person's approval and signature, and on and on through the chain of command. "Now five people get notified by E-mail, and they can log into the system, approve it, and electronically sign it," says Dave Rudzinsky, CIO of Hologic.

The automation has cut the company's engineering change cycle time from 44 days to 13 without adding any people. "Engineering can easily get bogged down in the change process," Rudzinsky says. "Now we can get the changes implemented faster and get products out faster."

Rudzinsky says he's looking forward to implementing the new version of Agile Software's suite, AgileMD, largely to take advantage of the new device-history-record capabilities. "We have a paper-based device-history record that for us is painful. We are dying to automate that," he says. Device-history records include all the information about a medical device as it's made, including exactly how a device is put together on the assembly floor, what the serial numbers are, and the results of all the tests along the way during assembly.

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