FDA Part 11 Compliance
Committee’s Summary of the Public Conference on the Technical Implementation of 21
CFR Part 11 (Electronic Records; Electronic Signatures) held on June 19 & 20, 2000 at
the Wyndham Franklin Plaza Hotel, Philadelphia, PA:
Part 11 affords persons substantial flexibility in selecting enabling technologies that
meet their respective needs, yet facilitate compliance with the rule. However, the Food
and Drug Administration (FDA) is aware that some individuals have found it challenging to
keep up with available technologies and adapt them to older electronic recordkeeping
systems. The Agency is mindful of the rapid pace at which such technologies are changing
and emerging, and the importance of keeping up with products and services that help ensure
that electronic records remain trustworthy, reliable, and compatible with FDA's public
health protection responsibilities.
With these concerns in mind, the FDA and the Parenteral Drug Association (PDA)
co-sponsored this event on industry's experience in implementing the technical provisions
of regulations (21 CFR Part 11) on electronic records and electronic signatures.
This meeting was open to all FDA regulated industries as well as suppliers of computer
technologies and services designed for use with electronic records. Attendees had an
opportunity to ask questions of presenters.
In attendance were 900 individuals, the majority from pharmaceutical and medical device
industries, although other FDA regulated industries were also represented. The large
number of attendees clearly underscored the rapidly growing interest in this subject.
The scope of this meeting was limited to experience in implementing Part 11's technical
requirements. The main objectives were to:
- Hold an open forum for exchanging information among the regulated industries on their
experiences in implementing the rule's technical provisions; and,
- Have a better understanding of the currently available and future tools/resources that
enable persons to comply with those technical requirements.
We intend to use the outcome of the conference to assist the Committee in preparing
industry guidance documents. Based on our assessment of the meeting and comments received
from attendees, we conclude that our objectives were met.
This meeting was not intended to be a forum to discuss the merits of the rule, nor a
tutorial on the regulation. It was also expected that attendees would have a basic
understanding of Part 11. However, it was evident by the nature of questions posed to our
panelists and attendee comments that many attendees had different expectations for this
meeting. We believe this may indicate that some attendees either misunderstood or did not
read the meeting's description statements presented in the Federal Register notice, the
Agency's web site and in PDA's literature and web site.
During the conference, we listened to 22 speakers from the regulated industry, service
providers, and other parties in electronic commerce and electronic government. The
presentations covered:
- Archiving procedures;
- Record integrity and audit trails;
- Electronic signatures; and,
- Electronic recordkeeping in clinical studies.
The following themes emerged from the conference:
- Agency guidance to industry is needed, and soon. Industry would like the guidance to be
issued in a modular manner, with easier issues addressed first and more complex issues
covered later;
- Products and services are currently available to enable compliance with Part 11
technical provisions. However, the solutions are available as a mosaic of parts that firms
must assemble on a case by case basis to meet their individual needs. Among the adaptable
solutions we heard about were: reusable code, XML, Java and Active X, Windows NT access
and security controls, and source code versioning control software. Persons are unlikely
to find turnkey, "one size fits all" applications.
- Providers of products and services that enable Part 11 compliance are prepared to meet
the needs of their clients. Suppliers would like stability in requirements, and their
customers need to be specific in the features they desire, rather than asking broadly for
"Part 11 compliance." Service providers are able to provide needed solutions
quickly; one speaker commented that software revisions could be prepared in as few as six
months.
- Part 11 technical provisions exist in the domains of electronic commerce and electronic
government. Other industries have already achieved the rule's objectives.
It was evident that all present recognized the increasing importance and need for using
electronic records and signatures, as well for compliance with this regulation. Part 11
was recognized as a "sentinel regulation" that other regulatory bodies may
emulate.
We retained the compilation of audience questions for use in preparing guidances.
In his conference closing remarks, Mr. John Marzilli, Deputy Associate Commissioner for
Regulatory Affairs, stated the FDA's commitment to preparing Part 11 guidance on subjects
that include:
- Systems validation;
- Audit trails;
- Time stamps;
- General security;
- Archiving; and,
- Predicate rule considerations in identifying what a required record is
Mr. Marzilli also said that FDA would follow its good guidance practices in developing
the documents. He added that we will hear from all interested parties and hold
constructive dialog on a continuing basis, as the Part 11 Compliance Committee has already
done, and we will continue that exchange in order to consider a variety of views and
technical approaches. He also stated that, like the rule itself, our guidance will afford
persons the maximum flexibility in selecting from a broad range of technologies.
Mr. Marzilli emphasized, however, that FDA, and FDA alone, has the task of preparing
and issuing FDA guidance to industry, and that we cannot collaborate with one or more
entities to the exclusion of others.
Mr. Marzilli concluded by saying that the guidance, and our overall implementation of
Part 11 will be shaped not only by industry input, but also:
- Our field experience with the rule (problems we continue to find that impact product
quality and safety and data integrity);
- Emerging products and services;
- Technology trends; and,
- The influences of electronic government and electronic commerce.
Paul J. Motise, Executive Secretary, FDA Part 11 Compliance Committee
DOC ID ConferenceSummary.doc 09/27/00
Hypertext Page prepared: November 02, 2000 tc
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