21 CFR PART 11 REGULATIONS 21 CFR PART 11 REGULATIONS RECOMMENDATIONS FOR CHANGES RECOMMENDATIONS FOR CHANGES FDA PUBLIC MEETING ON PART 11 FDA PUBLIC MEETING ON PART 11 REGULATIONS – JUNE 11, 2004 REGULATIONS – JUNE 11, 2004 NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION (NEMA) RICHARD EATON - NEMA RAVI NABAR, PH.D. – EASTMAN KODAK
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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
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
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
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
““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
PROPOSED SOLUTIONSPROPOSED SOLUTIONS
ALTERNATIVE A:– Withdraw Part 11 Regulations in favor of
Predicate Rules
ALTERNATIVE B:– Change Part 11 Regulations to “Guidance”
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
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
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
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