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Originally Published MX January/February 2005

IT IN HEALTHCARE

Reexamining E-Records

FDA rules for electronic compliance documents are headed toward a major overhaul.

Christina Elston

Once upon a time, medical device companies could expect to make their manufacturing processes more efficient by using the same real-time management systems used by other types of companies. "In the old world, medical product companies could use the same systems that were being used in other industries, as long as they paid close attention to the tracking and control of materials, to good manufacturing practices (GMPs), and to their ability to support recalls," says Bill Burke, president and CEO of Merit Solutions (Wheaton, IL).

But that was before FDA went electronic.

In 1997, FDA issued a new regulation designed to make it easier for manufacturers to use wholly electronic methods of maintaining and approving compliance-related records.1 The new regulation, 21 CFR 11—commonly referred to as Part 11—was a good idea. But it soon became clear that FDA had no idea how to implement it.

After several years of deliberation, FDA finally began issuing guidances on the use of electronic records and signatures in 2001.2–4 The appearance of these guidances opened the floodgates for the creation of more-specialized IT systems for medical product manufacturers. Since that time, the agency's requirements for data accountability, reliability and auditability of electronic systems, records protection, and security have been the major drivers for the design of industry-specific systems that address these needs.

IT Suppliers Respond

Part 11 "took the somewhat-open-to-interpretation area of the GMP and placed more-stringent requirements on it," says Burke. Merit Solutions is one of several software companies specializing in full Part 11 compliance for pharmaceutical and medical manufacturers.

For most medical product companies, meeting the requirements of Part 11 meant that software originally designed for use in other industries was no longer sufficient. And many software vendors serving other industries had to reengineer their entire platforms to comply with the new regulation. Part 11 was "probably the most significant change in IT from our standpoint," says Mark Albano, marketing manager at Honeywell Process Solutions (Morris Township, NJ). The biggest adaptation, he says, was in "making sure the electronic signatures were properly secure."

In order to continue serving the medical market, even firms that offer customizable systems have had to make modifications. ASI DataMyte Inc. (Plymouth, MN), which offers configurable off-the-shelf hardware and software, enhanced its electronic signature capabilities in order to meet the needs of the medical market. According to Peter Belsito, director of software engineering, the company has added the capability for operators to electronically sign records at different stages in the process, and has built in the capability to manage electronic signatures as employees are hired, leave the company, or change jobs within the company.

Change on the Way

More changes resulting from Part 11 are likely to come in the future. In August 2003, FDA announced its intention to reexamine the application of the regulation to all regulated products, and to change the rule in response to that reexamination.5 According to the agency, the review was initiated as a result of widespread concern in industry and among product vendors about the interpretation and implementation of the regulation. Some interpretations of the requirements related to validation, audit trails, record retention, record copying, and legacy systems could result in unintended consequences such as the following.

  • Placing unnecessary restrictions on the use of electronic technology in a manner inconsistent with FDA's stated intent for the rule.
  • Significantly increasing the costs of compliance to an extent that was not contemplated when the rule was drafted.
  • Discouraging innovation and technological advances without providing a significant public health benefit.

A public meeting about how to change Part 11 was to have been held in June 2004, but was canceled because of memorial observances for Former President Ronald Reagan.6 The FDA docket for the meeting has nevertheless been filled with dozens of industry comments.7,8 And a coalition of trade associations led by AdvaMed (Washington, DC) has even recommended that the agency rescind the rule entirely (see sidebar).9

It is not clear when FDA intends to close its reexamination and begin reworking Part 11. In the meantime, however, the agency has withdrawn all of its previously issued guidances relating to the rule.

References

  1. "Electronic Records; Electronic Signatures," Code of Federal Regulations, 21 CFR 11.
  2. Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Glossary of Terms, draft guidance (Rockville, MD: FDA, 2001); available from Internet: www.fda.gov/ohrms/dockets/98fr/001543gd.pdf.
  3. Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Electronic Copies of Electronic Records, draft guidance (Rockville, MD: FDA, 2002); available from Internet: www.fda.gov/cber/gdlns/esigcopies.pdf.
  4. Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Validation, draft guidance (Rockville, MD: FDA, 2001); available from Internet: www.fda.gov/ohrms/dockets/98fr/001538gd.pdf.
  5. Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures—Scope and Application (Rockville, MD: FDA, 2003); available from Internet: www.fda.gov/cder/guidance/5667fnl.htm.
  6. "Electronic Record; Electronic Signatures; Public Meeting," Federal Register 69, no. 68 (April 8, 2004): 18591–18593.
  7. FDA Docket 2004N-0133.
  8. MR Geiger, "21 CFR Part 11 FDA Public Meeting; Comments Presented by M. Rita Geiger, President/CEO, InfoStrength Inc.," prepared for FDA Part 11 Public Meeting, in Washington, DC (June 11, 2004); available from Internet: www.fda.gov/ohrms/dockets/dockets/04n0133/04N-0133_emc-000038-01.ppt.
  9. FJ Sena and F Razzaghi, "Industry Coalition on Part 11," prepared for FDA Part 11 Public Meeting, in Washington, DC (June 11, 2004); available from Internet: www.fda.gov/ohrms/dockets/dockets/04n0133/04N-0133_emc-000033-01.ppt.

Illustrations by KELLY JOHNSON

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