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 is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
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  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: Tuesday, January 23 through Friday, January 26 from at 11 am – 3 pm EST

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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