While the FDA’s rules for life science organizations and how they handle electronic records and electronic signatures have been out for some time, many companies find compliance elusive. At eLeaP, we understand how challenging it can be to comply with government mandates, particularly when the information you need is written in legalese and so difficult to understand. We created this 21 CFR Part 11 checklist PDF to help simplify matters and ensure that you’re able to move forward. You can download a PDF version of the CFR Part 11 checklist here.

21 CFR Part 11 Checklist PDF

21 CFR Part 11 Checklist PDF Part 1

Systems Overview

Systems Validation

Systems Record Control

System Access Control

System Enforcement and Assurance

System Training and Documentation

System Information and More

System Controls

Linking Signatures to Records

Signatures and Controls

Beyond the 21 CFR Part 11 Checklist PDF

As you can see, there’s a lot that goes into ensuring compliance with 21 CFR Part 11. What’s more, these steps apply to all electronic systems your life science company uses, from payroll to learning and development. Each system must be validated to ensure that it meets the requirements we’ve discussed above. That can be challenging and time-consuming. You can also download the whitepaper “How to Prepare for a 21 CFR Part 11 FDA Inspection“.

At eLeaP, we’ve done your due diligence for you. Our LMS is fully validated and compliant with 21 CFR Part 11, allowing you to save time and hassle while still taking advantage of the modern technology today’s businesses and learners need. Contact us today to schedule your custom consultation and to learn more about our cloud-based learning management system.