Transcript CDER’s 21 CFR Part 11 Implementation Study

CDER’s 21 CFR Part 11
Implementation Study
Greg Brolund
Associate Director, Office of
Information Technology, CDER/FDA
11/2/99
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Background
 CDER
heard many concerns about the
implementation of Part 11
Timing
 Legacy Systems
 Inconsistent information from FDA
 483’s
 etc.

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Implementation Recommendation
Project
 CDER
task force directed to make
recommendations for implementation of
Part 11
Directed by Dr. Janet Woodcock - May 99
 To be based on an analysis of the issues raised
by industry, FDA inspectors, and the software
industry.

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Pharmaceutical Interviews
 Representatives
of four large
pharmaceutical firms were interviewed.
The groups consisted of people who are
involved with the planning and
implementation of measures to comply with
Part 11 and represented the GxP areas as
well as regulatory, legal, and information
technology areas.
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FDA Interviews
 Two
FDA inspectors and several FDA staff
familiar with inspections, compliance policy
and Part 11 were interviewed.
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Software Industry Interviews
 Two
major software companies dealing with
the pharmaceutical industry were
interviewed.
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CDER Task Force Analysis
 The
CDER task force reviewed the results
of the interviews and supporting material.
The task force produced the implementation
recommendations.
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Common Industry Part 11
Activities
 Assess
current systems and try to learn as much
about the FDA interpretation of the rule as
possible.
 Create and internal interpretation based on current
business practices, impact of change on system
quality, cost of changes, and feasibility of changes
to meet the requirements of Part 11.
 Create implementation plans.
 Conduct training of company staff in the meaning
of Part 11 and SOPs to comply with Part 11.
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Common Industry Concerns
 Why
are existing, validated systems that
include both paper and electronic
components are no longer acceptable?
 Long term archiving of electronic records is
not technologically feasible.
 What is the true scope of Part 11?
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Concerns Continued
 Automated
audit trails are not feasible for
many existing systems and are often not
available in new software, especially in
manufacturing systems.
 Company systems will take years to be
made compliant with the current perceived
FDA interpretation of Part 11.
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Concerns Continued
 The
cost to become Part 11 compliant for a
global company is estimated to be > $100
million.
 The cost is perceived to far out weigh the
benefit.
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FDA Concerns (sample)
 Electronic
records are easier to falsify than
paper records if adequate controls are not in
place.
 Hybrid systems are difficult to validate and
verify
 Records must be inspected on site and over
long periods of time. Archiving and
retrieving the records could be a problem
for inspectors.
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FDA Concerns Continued
 Paper
printouts of electronic records may
omit important information.
Changes
 Signatures
 Analysis parameters

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Two Software Providers
 Difficult
to know exactly what is required.
 Other industries don’t have the same
electronic record keeping requirements.
 Companies would like FDA to review their
interpretation and implementation for Part
11 compliance
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Task Force Recommendations
Create a Part 11 Implementation Guidance for
Industry that addresses specific issues raised by
FDA and industry.
 Create a position of Electronic Signature /
Electronic Records Ombudsman or Coordinator to
coordinate policy, internal and external training,
and coordinate answers or clarification for
industry and within FDA

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Recommendations
Conduct public workshops to explain the
implementation policy and post appropriate
materials on the FDA internet web site.
 Issue clarifications on the existing Computers in
Clinical Trials Guidance.
 Create case studies of the characteristics of
acceptable systems under the implementation
policy without endorsing specific companies or
products

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Recommendations
 Provide
FDA participants on instrument
data interchange standards committees such
as those sponsored by ASTM and IUPAC.
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Points to be Addressed in Specific
Guidance
Acceptability of paper records that are generated
from electronic data
 Hybrid systems - what kind of hybrid system is
acceptable.
 Legacy Systems - describe the characteristic of a
legacy system that is acceptable until it can be
upgraded.
 Length of time allowed to phase out legacy
systems or marginal hybrid systems.

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Guidance Continued



Electronic record archiving. Possibilities include printing
the records with all available "meta" data. The paper
becomes the official archive.
Scope - describe what records in a process are covered by
Part 11.
Automated audit trails - describe audit trails that are part of
a hybrid system. For example, if the electronic data is
printed and the printed record is the official record, can
changes be made in the usual way to the paper record to
satisfy the audit trail requirement?
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Guidance Continued
Hospital records systems - describe the level of
industry control and Part 11 compliance that is
expected over systems such as hospital patient
record keeping systems that are typically outside
of FDA jurisdiction.
 Electronic Signatures - describe the acceptability
of systems that use server based electronic
signatures in conjunction with standard security
and accessibility system controls to verify the
identity of the "signer" of the electronic record.

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Current Status
 The
FDA Office of Regulatory Affairs has
been made responsible for FDA’s Part 11
implementation policy.
 ORA has been given a copy of the CDER
task force report and recommendations.
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