21 CFR Part 11

SoftwareCPR® can assist with achieving and maintaining compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures requirements.  Many manufacturers are utilizing electronics records in greater numbers.  Certainly the use of electronic records can help achieve greater process efficiencies.  However, the manufacturer should consider how the integrity of the electronic records will be managed and maintained throughout the required records retention period.  We can help with:

  • On-site Training
  • Regulatory Risk Analysis
  • Assessments
  • Vendor Software Evaluation
  • Validation Assistance
  • Realistic Advice Consistent With Evolving FDA Interpretation

Selected FDA Part 11 Related Documents and Links:

Part11-cd0314-Early Draft of Rule in 2003 21 CFR Part 11 Feb 2003 Federal Register Notice Announcing Major Redirection for Part 11

Part11FinalGuidanceFromFDA-Aug2003 21 CFR Part 11 Final Scope and Application Guidance

FDAClinicalTrialsComputerSystemGuidance-051007-04d-0440-gdl0002-May2007 May 2007 Revised FDA Guidance Computerized Systems Used in Clinical Trials

Part11FinalRule-March2007 21 CFR Part 11 Electronic Records;Electronic Signatures Rule

FDA-InvestigationsOMerecordssection2007 FDA ORA IOM Electronic Copies Investigator Guidance

CDRHInfo-collection-reqmtsExcerpts-July2001 QS Regulation Record Keeping Requirements CDRH Report

Also, search for “Warning Letters” and “Part 11” for warning letters related to Part 11 compliance.

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.
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