Part 11 and FDA Inspections by ruf23140

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									Part 11 and FDA Inspections

         Christine Nelson
       Office of Compliance
Center for Devices and Radiological
              Health
        mcn@cdrh.fda.gov
               Introduction
 Records   and signatures subject to
 part 11
 Predicate   rules and part 11
 Types of records maintained
 electronically
           Introduction (Cont.)
 FDA    inspection concerns
 Warning   Letters, part 11 & predicate
 rules
 Advantages    of electronic records
 Records and Signatures Subject
           to Part 11
 Any record required by FDA that is in
 electronic form

 Anyelectronic signature that appears in
 an FDA-required record, whether or not
 signature is required

 Electronic   submissions to FDA
     Predicate Rule & Part 11
 Records   are required by a “predicate
 rule”

 The   predicate rule mandates:
  – What records must be maintained
  – The content of records
  – Whether signatures are required
  – How long records must be maintained
Common Types of Records Kept
      Electronically
 Specifications

 Sops

 Equipment     maintenance
 Calibration

 Environmental    monitoring records
 Test   and inspection records
    Common Types of Records
    Kept Electronically (Cont.)
 Distribution   records
 Training   records
 Statistical   analysis software
 Adverse    event reports
 Complaints

 Clinical   data/studies
         FDA Inspections
 Q:  Will inspections be conducted solely
 for the purpose of checking compliance
 with part 11?
 A: Highly unlikely. Inspections are
 conducted for many reasons.
 Compliance with part 11 can be
 evaluated during inspections conducted
 for other reasons.
          FDA Inspections
 Q: How will investigator evaluate
 compliance with part 11 during an
 inspection for another purpose?

 A:An investigator will look at records to
 evaluate compliance with the predicate
 rule. At the same time, the investigator
 may check compliance with part 11 for
 adequacy of recordkeeping.
         Investigator Concerns
 Does the system meet part 11
 requirements?
 Has   the system been validated?
 Have part 11 administrative
 requirements been met?
 Has certification been submitted for
 electronic signatures?
           Use of Part 11
 Q:should we expect to see part 11 cited
 in warning letters?

 A:No. If there are deficiencies in the
 electronic recordkeeping or signature
 system, the predicate rule that requires
 the records will be referenced.
 Examples From Warning Letter
 Engineering drawings for manufacturing
 equipment and devices are stored in
 AutoCAD form on a desktop computer.
 The storage device was not protected
 from unauthorized access and
 modification of the drawings.
 Examples From Warning Letter
 Therewas no established procedure to
 control secure retention of master
 programs to identify and retain all
 versions of updates as written.
 Examples From Warning Letter
 ThePLC controlling the manufacturing
 process had neither physical nor
 password access control to prevent
 unauthorized access to set point
 changes.
Advantages of Keeping Records
        Electronically
 Shorter   inspections:
  – You can retrieve records faster
  – FDA investigator can search and sort
    electronic records more quickly
Advantages of Keeping Records
        Electronically
 Record integrity - paper records subject
 to damage and deterioration, BUT take
 appropriate measures to protect
 electronic records
                Summary
 Records   and signatures subject to
 part 11
 Predicate   rules and part 11
 Types of records maintained
 electronically
            Summary (Cont.)
 FDA    inspection concerns
 Warning   Letters, part 11 & predicate
 rules
 Advantages    of electronic records
The End

								
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