Watch and Learn : 21 CFR Part 11 Regulations
This article is meant to provide a very high level overview of the key elements of 21 CFR Part 11 regulations from the Food and Drug Administration. It delves into the following topics:
1. Introduction to 21 CFR Part 11 regulations
2. Key elements of 21 CFR Part 11
• Electronic Records : Definition of Electronic Records
• Electronic Signatures: Definition of Electronic Signatures
• Audit Trails: Definition of Audit Trails, ALCOA definition, basics of what goes into an audit trail.
3. Deeper dive into Subpart B: Electronic Records
• Subpart B: 11.10 and 11.20 - Controls for Closed and Open systems
• Subpart 11.50: Signature Manifestations
• Subpart 11.70: Electronic Record Linking
4. Deeper dive into Subpart C: Electronic Signatures
• Maintenance of uniqueness
• Periodic revisions of passwords
• Prevention of unauthorized actions
5. Advantages for Illumina LCM Consumables Manufacturing
• Trending
• Speeding up the approval process for records
• Cost savings
• Efficiency in maintenance, retrieval and submission of records.
6. Proposed action plan for LCM Consumables Manufacturing
For more information on 21 CFR part 11 regulations, please visit www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
For more information on Quality System (QS) Regulation/Medical Device Good Manufacturing Practices, visit www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/
For More information on Illumina products, visit www.illumina.com/
For more information on 21 CFR Part 820: Quality System Regulations, visit www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820