FDA’s 21 CFR Part 11 Add-on Inspections

Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether in the pharmaceuticals, medical device, biologics or dietary supplements industries. Many of these applications feed into cGMP data acquisition and records, requiring addressing 21 CFR Part 11. A quick review of Internet forums will show much confusion about the subject. It is increasingly being used for e-records and e-signatures and in company-wide ERP (Enterprise Resource Planning) systems. Regulatory auditors are more comfortable with delving into software issues. Effective and real world software V&V is even more important in today’s resource constrained industrial environment.

The verification and validation of medical industry software is coming under increased scrutiny by the U.S. FDA, and especially any software involved in cGMP compliance.

In this webinar, our presenter John Lincoln, will address the use of the FDA guidance documents, GAMP, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. This session will also discuss and explain about a compliant, field tested (FDA and Notified Body) 21 CFR Part 11 software documentation model.

This discussion will focus on a preferred U.S. FDA documentation “model” in various applications, including ERP, in-device, as-device, process/equipment control, wherever cGMP data / records are gathered, utilized, stored and retrieved.

Areas Covered in the Session :

  • 21 CFR Part 11, Electronic Records / Electronic Signatures – What it is and what it isn’t?
  • The proven V&V 11-element “model” – useful for all software V&V
  • Developing test cases / scripts from Part 11
  • “Risk Based” – what it means in SW V&V and how it should be used
  • Why Part 11 violations seldom show up directly on 483’s, but are there nonetheless
  • Insights on Cloud issues and Agile issues
Who Will Benefit:

This webinar will provide valuable assistance to all the personnel / companies in the Medical Devices, Diagnostic, and to a lesser extent the Pharmaceutical and Biologics fields. The employees who will benefit include:

  • Senior management
  • Middle management
  • R&D
  • Engineering
  • Software
  • QA / RA
  • Manufacturing
  • Operations
  • Consultants
  • cGMP instructors
  • All personnel especially involved in product, process, validations, cGMP responsibilities


John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.



  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance