Summary of Part 11 Regulation - eRecords and eSignatures

What Will You Learn?

What 21 CFR Part 11 regulation is
What Electronic Records and Electronic Signatures are and which ones are subject to the requirements of Part 11
What Part 11 requires for compliance
How to interpret some arcane Part 11 regulation terms in today's rapidly advancing mobile computing world
How to manage computerized systems in your company with respect to Part 11
How to evaluate a system for Part 11 compliance (Gap Analysis)
Some practices for achieving compliance to Part 11 with your own eRecords and eSignatures

What Will You Get?

Unlimited access to this course for as long as the course remains in the active curriculum
- take as long as you need to complete the course
- revisit as often as you like
- refresh the acquired knowledge whenever you need

Intelligent, thought provoking and entertaining quizzes and exams
- challenging questions designed by experts
- randomly pulled questions from a larger library of questions
- passing the quizzes and exams is mandatory for successfully completing the course
- provides an effectiveness measure for the training

Course Materials
- Example Part 11 Compliance SOP
- Part 11 assessment spreadsheet
- Part 11 inventory spreadsheet

Certifications

Certificate of Completion
- upon review of critical amount of course content
- upon successfully passing the quizzes and final exam

Subject Matter Expert (SME) Badge
- This course is part of the "eSecurity and ePrivacy" and "Software Validation" SME Certifications. It takes you one step closer to earning those SME Badges.

SuperSmart Points

And More...