Greenwich time for Part 11, central enforcement coming : Motise seen going to ORA to help training.

Electronic records might have to be time/date stamped using an international standard for Greenwich time - versus the local time and date - and companies may see more-experienced investigators inspecting their facilities for compliance with the 1997 electronic signature/ records rule (21 CFR Part 11), a key Center for Drugs official said Aug. 26.

Paul Motise, of CDER's Office of Compliance, Division of Manufacturing and Product Quality, told an Institute for Validation Technology (IVT) conference in Washington that the move to Greenwich time will likely appear in the agency's next guidance document for Part 11. He said the document is still not even written.

"I've heard enough persuasive arguments to move FDA to allow expressing time in Greenwich mean time, plus or minus," Motise said.

He said the guidance will adopt an International Standards Organization (ISO) standard for time, ISO 8601.

Motise said "time snaps" are important for FDA to determine if there were discrepancies in electronic records.

The guidance also will suggest the content for audit trails, another salient feature of Part 11; terminal controls - such as computer "time outs" when someone is logged on and walks away from a computer terminal; password controls; sequencing and device checks and the types of media and formats that FDA can work with if firms choose to supply the agency (such as an inspector) with electronic records.

Part 11 cadre due in 2000

Motise also said that in fiscal 2000 - which begins Oct. 1 - FDA will begin training a core cadre of inspectors to be experienced in enforcing Part 11. He estimated that between 50 to 100 experts will receive such training.

To facilitate this effort, Motise said he may soon join the Office of Enforcement in FDA's Office of Regulatory Affairs (ORA), which will have "much more central control" over how Part 11 is enforced during plant inspections.

FDA got the ball rolling in June with a national, satellite videoconference to all districts and inspectors, in which the principles of the "E-Sig" rule were espoused. On Jan. 21, the agency formally unveiled its Compliance Policy Guide (160.850), which spells out how FDA is enforcing the regulation.

He also announced the agency will hold another videoconference for industry and inspectors Oct. 21. A similar telecast last January was over booked.

Motise acknowledged there have been several warning letters of late regarding Part 11, one to a European firm (which he did not identify) that "came within a hair's breath" of getting its products barred from U.S. entry until it committed to clearing up violations in its computer systems.

He argued that in talking to information technology personnel at drug companies, there is little surprise or concern about Part 11, but said most of the resistance and concern has come from regulatory affairs and QA personnel.

At the IVT meeting, there were few open criticisms of the regulation among the 150 in attendance, except some concerns at Motise's statement that computer-aided design (CAD) files for production facilities had to comply with the regulation.

But at an Institute for International Research conference on bulk drugs in Philadelphia July 20, Robert Wherry, senior manager for QA at Sepracor, said: "It's ridiculous that FDA has spent so much time in the last two-and-half years on Part 11 when Y2K has far greater potential impact."

Motise contended that Part 11 has pushed firms to scrap or revalidate legacy computers and go with systems that are not only Y2K compliant, but meet the requirements of the E-Sig rule.

Motise: E-Sig rule is model

He said FDA's rule has become the model for other agencies that regulate the drug, device and biologics industries.

On March 5, the White House Office of Management and Budget (OMB) issued a proposal to implement the Government Paperwork Elimination Act of 1998, which Motise said "requires agencies to do by the year 2003 what FDA already has done," namely, Part 11.

Under the OMB initiative, Motise said, the Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) and any other agency with whom FDA-regulated companies interact will be required to adopt Part 11 principles. He noted the Health Care Financing Administration in August 1998 initiated rulemaking along the lines of Part 11 and that the U.K. has adopted FDA's rule intact.

Motise said the OMB rule gives the Justice Department the power to sue companies or seek criminal sanctions against firms that violate the regulations. He added that EPA and OSHA already have talked with FDA on how to implement similar rules.

Hence, he argued, the firms regulated by FDA also will encounter similar expectations on electronic records integrity from OSHA, EPA or any other government agency.

Motise's presentation, which includes the new CPG, a list of Part 11 Web links and the OMB proposal, is $15 plus retrieval, Doc. 108730M.