200 inspectors train on Part 11, but focus still on submissions.

FDA is training more than 200 field investigators on electronic records validation under the agency's electronic records/signature rule (21 CFR Part 11), but the emphasis on the "signature" facet of the regulation appears to be bioresearch monitoring and electronic submissions.

Addressing the Drug Information Assn.'s Sept. 13-15 sixth annual computer validation conference, Dr. James McCormack, Ph.D., coordinator of FDA's Bioresearch Monitoring Program, said the agency does not plan any Part 11-specific inspections. He said a firm's computer systems and validation evidence will be checked only as part of the agency's usual inspection activities.

"If we are conducting GMP inspections, we will look at computerized systems' electronic records used in a toxicology laboratory, if it's a clinical investigator inspection. We will look at the electronic systems that are used at that clinical site."

He told the Washington conference: "In the bioresearch monitoring area, since most of our inspections are triggered by the presence of dating in applications, we're just now beginning to receive data that were collected after the effective date of Part 11."

He said field investigators will be asking questions about those systems, and firms should expect investigators to have questions about the computerized systems, how they operate, who has access to them, the security aspects and about electronic record keeping.

Numerous Part 11 questions

McCormack found himself providing the same answer to several questioners about what is required of them under the new regulations governing electronic submissions: if FDA requires the information that is presented in the electronic submission, the electronic system that produced that submission must be validated according to FDA regulations.

"But we are moving in the direction of electronic submissions," said Christine Nelson, director of international affairs for the Center for Devices. She said FDA will be requiring an increasing amount of submissions in electronic form and companies dealing with the agency need to understand that Part 11 is the minimum of what they need to do to maintain the integrity and trustworthiness of their electronic records. Nelson reminded them other regulations are in the works at FDA taking the matter even farther down the road toward the standard way of operating.

The electronic signature is only part of that effort, she said, and when used, it also must be validated as the signature of the person authorized to make the submission. She said this is a major area of training of the field investigators.

E-records a de facto 'rule'

Although using electronic signatures when submitting information to FDA and other parts of the government still is voluntary, the reality of today's computer-based society makes E-Sig mandatory, Nelson said.

"Today, if you don't operate electronically, if you don't have electronic records, you're at a real disadvantage," she said. "So, the regulation is looking less like a voluntary standard and more like a mandatory standard, although that was not our intention."

Nelson reminded the audience that "Part 11 works hand in hand with FDA's predicate rule." FDA knows the transition to electronic submissions and the validation of those systems, many of which are likely to be embodied in off-the-shelf software, will be expensive for many manufacturers of products regulated by FDA, she said.

Firms also are ultimately responsible for the software they use, whether off-the-shelf or custom-made, Nelson added.

She guessed that the sudden intense interest in Part 11 is a response delayed from last year and earlier this year by preoccupation with dealing with the Y2K bug.

If attendees and others still have questions, Nelson said, she advised them to read the preamble of the Part 11 rule for guidance on what is expected of regulated firms.

She said more guidance will be emerging piecemeal from the agency over the next year or two, with the first currently planned for the middle of 2001.