Thank you for reading our introduction to 21 CFR 11.
For additional training or consultation, contact Ofni Systems. A: 21 CFR 11 requires that closed computer systems must have a collection of technological and procedural controls to protect data within the system.
A: All computer systems which store data which is used to make Quality decisions or data which will be reported to the FDA must be compliant with 21 CFR 11.
In laboratory situations, this includes any laboratory results used to determine quality, safety, strength, efficacy, or purity.
Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.Open computer systems must also include controls to ensure that all records are authentic, incorruptible, and (where applicable) confidential.
Q: What computer systems must be compliant with 21 CFR 11?Recorded Learning from Recent Warning Letters and 483's Related to Computer Validation and Part 11 With Case Studies to Avoid and Respond to 483's and Warning Letters Recorded Learning from Recent Warning Letters Related to Good Laboratory Practices For Preparation of FDA and International GLP Inspections Electronic Records Periodic Review and Evaluation of Computer Systems With strategies and tools for FDA and EU compliance July 28, 2011 Understanding and Implementing the New Final EU Annex 11 Learn about specific requirements and get tools for implementation Recorded Understanding and Preparing for FDA's New Part 11 Inspection Program With 10 Best Practice Guides for Easy Implementation Recorded Electronic Raw Data in Regulated Environments Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance Recorded FDA's 21 CFR Part 11 Introduction and Strategies and Tools for Implementation Recorded Cost Effective Electronic Data Archiving for FDA Compliance Understanding and Implementing the New GAMP Guide Recorded Electronic Audit Trails for FDA Compliance Requirements - Design - Implementation - Validation - Documentation Recorded FDA Compliant Electronic Records Management Recorded Using the SAFE Standard for Digital Signatures For legally enforceable IP Protection, Electronic Transactions and FDA Submissions Recorded Auditing Computer Systems for Part 11 and Annex 11 Compliance Prepare your organization for upcoming FDA and EU inspection Recorded Laboratories LABORATORIES Understanding the Updated USP Chapters 232/233 for Metal Impurities With SOPs and Case Studies for Easy Implementation Recorded Download more than 500 documents: SOPs, examples, templates, checklists, FDA waning letters, 483 inspectional observations, FDA and other official guidelines, presentations/publications from FDA personnel.