LCM Validations Watch and Learn : 21 CFR Part 11 Regulations

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...
For more information on Quality System (QS) Regulation/Medical Device Good Manufacturing Practices, visit www.fda.gov/Me...
For More information on Illumina products, visit www.illumina.com/
For more information on 21 CFR Part 820: Quality System Regulations, visit www.accessdata...