Download - FDA's 21 CFR 11 rules
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21 CFR PART 11 REGULATIONS21 CFR PART 11 REGULATIONSRECOMMENDATIONS FOR CHANGESRECOMMENDATIONS FOR CHANGES
FDA PUBLIC MEETING ON PART 11 FDA PUBLIC MEETING ON PART 11 REGULATIONS – JUNE 11, 2004REGULATIONS – JUNE 11, 2004
NATIONAL ELECTRICAL MANUFACTURERS
ASSOCIATION (NEMA)
RICHARD EATON - NEMA
RAVI NABAR, PH.D. – EASTMAN KODAK
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National Electrical Manufacturers National Electrical Manufacturers Association (NEMA)Association (NEMA)
- Largest U.S. trade association representing America’s electroindustry
- Diagnostic Imaging and Therapy Systems Division of NEMA represents manufacturers of:X-ray, CT, diagnostic ultrasound, magnetic resonance,
nuclear medicine imaging, radiation therapy and medical imaging informatics equipment
- Member of Part 11 Coalition
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OVERVIEWOVERVIEW
- Original intended objectives of Part 11 Regulations
- “The Problem” – Part 11 Duplication of Predicate Rules
- NEMA presentation addresses Question 3 – Part 11 Subpart B Electronic Records
- Proposed Solution
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Original intended key objectives of Original intended key objectives of Part 11 RegulationsPart 11 Regulations
- Retention/documentation of records
- Integrity/security of Records
- FDA Access to Records
- Authentication of Electronic Signatures
- Accountability for Maintaining Records System
- Validation
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““THE PROBLEM”THE PROBLEM”DUPLICATION – PART 11 AND DUPLICATION – PART 11 AND
PREDICATE RULESPREDICATE RULES
- Part 11 Regulations’ Objectives covered by Predicate Rules
- Part 11 Regulations are too prescriptive- Part 11 Regulations + Predicate Rules –
Duplicative and Confusing- Duplicative Regulations are Contrary to “least
burdensome” principles to minimize excess regulation
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PROPOSED SOLUTIONSPROPOSED SOLUTIONS
ALTERNATIVE A:– Withdraw Part 11 Regulations in favor of
Predicate Rules
ALTERNATIVE B:– Change Part 11 Regulations to “Guidance”
document
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PREDICATE RULES ADDRESS PREDICATE RULES ADDRESS PART 11 OBJECTIVESPART 11 OBJECTIVES
- Quality System Regulation
- Medical Device Reporting
- Corrections and Removals
- Good Laboratory Practices
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QUALITY SYSTEM REGULATION QUALITY SYSTEM REGULATION DUPLICATED BY PART 11 REGS. *DUPLICATED BY PART 11 REGS. *
PART 11 REGS. - 21 CFR 11.10(a) Validation of Systems- 21 CFR 11.10(b) Controls – Closed Systems -Generate copies of records for inspection- 21 CFR 11.10(c) Protection of Records to enable retrieval
LIMIT ACCESS TO AUTHORIZED INDIVIDUALS
OPERATIONAL SYSTEM CHECKS
QSR REGULATION- 21 CFR 820.70 (i) Production/Process Controls- 21 CFR 820.40 – Document Controls- 21 CFR 820.180 – General Requirements
- 21 CFR 820.40, 820.180 * Intent of Predicate Rules is the
same as Part 11 Regulations, but less prescriptive
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QUALITY SYSTEM REGULATION QUALITY SYSTEM REGULATION DUPLICATED BY PART 11 REGS. DUPLICATED BY PART 11 REGS.
PART 11 REGS.-21 CFR 11.10(d)Limit Access to authorized
individuals
-21 CFR 11.10(e)Use of computer-generated
audit trails
QSR REGULATION
-21 CFR 820.40
Document Controls
-21 CFR 820.20
Mgmt. Responsibility
-21 CFR 820.40
Document Controls
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QUALITY SYSTEM REGULATIONQUALITY SYSTEM REGULATIONCOMPARED WITH PART 11 REGS.COMPARED WITH PART 11 REGS.
Part 11 REGS.
-21 CFR 11.10(f)
Operational checks
-21 CFR 11.10(g)
Authority checks
-21 CFR 11.10(h)
Device checks
QSR REGULATION
-21 CFR 820.70
Prod./Process control
-21 CFR 820.20
Mgmt. responsibility
-21 CFR 820.25
Personnel
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QUALITY SYSTEM REGULATIONQUALITY SYSTEM REGULATIONDUPLICATED BY PART 11 REGS.DUPLICATED BY PART 11 REGS.
PART 11 REGS.
-21 CFR 11.10(i)Education - personnel
-21 CFR 11.10(j)Accountability
-21 CFR 11.10(k)Controls – system
documentation
QSR REGULATION
-21 CFR 820.25Personnel
-21 CFR 820.20Mgmt. Responsibility
-21 CFR 820.40Document Controls
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MEDICAL DEVICE REPORTING MEDICAL DEVICE REPORTING REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS
PART 11 REGS.
- 21 CFR 11.10(b)
Controls – generate copies of records for inspection
- 21 CFR 11.10(c)
Protection of records to enable retrieval
MDR REGULATION
- 21 CFR 803.1
Maintain Records
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MEDICAL DEVICE REPORTING MEDICAL DEVICE REPORTING REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS
PART 11 REGS.
- 21 CFR 11.10(b) Controls
- 21 CFR 11.10(b)
Controls
- 21 CFR 11.10(k)
Controls – System Documentation
MDR REGULATION
- 21 CFR 803.10
Required Reports
- 21 CFR 803.14
Electronic Reporting
- 21 CFR 803.17
Written MDR Procedures
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MEDICAL DEVICE REPORTING MEDICAL DEVICE REPORTING REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS
PART 11 REGS.
- 21 CFR 11.10(e)
Audit trails
- 21 CFR 11.10(k)
Controls – system documentation
MDR REGULATION
- 21 CFR 803.18
File/Distributor Reports (MDR events)
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CORRECTIONS AND REMOVALS CORRECTIONS AND REMOVALS REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS
PART 11 REGS.
- 21 CFR 11.10(b)
Controls- 21 CFR 11.10 (c)
Protection of Records
CORRECT. AND REMOVALS REG.
- 21 CFR 806.1
Maintain Records
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CORRECTIONS AND REMOVALS CORRECTIONS AND REMOVALS REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONSPART 11 REGS.
- 21 CFR 11.10(b)
Controls
CORRECT. AND REMOVALS REG.
- 21 CFR 806.10
Corrections and Removals Reports
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CORRECTIONS AND REMOVALS CORRECTIONS AND REMOVALS REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS
PART 11 REGS.
- 21 CFR 11.10(b)
Controls
CORRECT. AND REMOVALS REG.
- 21 CFR 806.30
FDA Access to Records
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GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS
PART 11 REGS.
- 21 CFR 11.10(b)
Records for inspection
- 21 CFR 11.10(i)
Education/training of personnel
GOOD LAB. PRACTICE REG.
- 21 CFR 58.15
Inspection of records
- 21 CFR 58.29
Personnel – education and training
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GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS
PART 11 REGS.
- 21 CFR 11.10 ( c )
Protection of records
- 21 CFR 11.10 (k)
Appropriate controls over system documentation
GOOD LAB. PRACTICE REG.
- 21 CFR 58.33
Study Director – responsibility for documentation
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GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONSPART 11 REGS.
- 21 CFR 11.10(g) authority system checks- 21 CFR 11.10(k) Appropriate controls over
system documentation - 21 CFR 11.30 Controls over open
systems
GOOD LAB. PRACTICE REG.
- 21 CFR 58.35
Quality Assurance Unit
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GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS
PART 11 REGS.
- 21 CFR 11.10 ( c )
Controls over system documentation
GOOD LAB. PRACTICE REG.
- 21 CFR 58.81
Written standard operating procedures
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GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS
PART 11 REGS.
- 21 CFR 11.10(c) Protection of records- 21 CFR 11.10(k) Appropriate controls
over system documentation
GOOD LAB. PRACTICE REG.
- 21 CFR 59.190
Storage and retrieval
of records
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GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH
PART 11 REGULATIONSPART 11 REGULATIONS PART 11 REGS.
- 21 CFR 11.10( c) Protection of records- 21 CFR 11.10(k)
Appropriate controls for system documentation
GOOD LAB. PRACTICE REG.
- 21 CFR 58.195
Retention of records
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PREDICATE RULESPREDICATE RULES
- Acceptance by FDA and Industry- Part of Established Product Approval Process- Part of Long-Established Medical Device GMP Practice- Adequately Protects Public Health- Comprehensive – Covers all phases of product design,
development, manufacture and correction and problem reporting
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CONCLUSION AND CONCLUSION AND RECOMMENDATIONSRECOMMENDATIONS
- Part 11 Rules are duplicative, burdensome and too prescriptive
- Withdraw Part 11 Regulations in favor of predicate rules
- Convert Part 11 Regulations to a less prescriptive, risk-based guidance document
- NEMA ‘s goal is to work with FDA to achieve a practical regulatory solution which will meet the objectives of both FDA and industry