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