CFR Part 11 Terms & Definitions
CFR Part 11 Terms, Definitions, Checklists
Having an FDA 21 CFR Part 11 compliant learning management system can be the difference between strong performance and success versus negative FDA audit findings. If you are in the life sciences industry which comprises organizations such as drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated organizations, you must validated systems. Connect with an expert. Companies in pharmaceuticals, biotechnology, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, biomedical devices are required to strictly adhere to the 21 CFR Part 11 standard when it comes to record keeping especially electronic signatures.
eLeaP is a validated learning management system which compliance with Part 11. Here are some terms and definitions you need to understanding when it comes to Part 11 compliance.
CFR Part 11 Terms
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CFR Part 11
Electronic Records and Signatures
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CFR Part 11 Software
Electronic Records and Signatures
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CFR Part 11 Compliance
Electronic Records and Signatures
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21 CFR Part 11 Summary
Tips for Creating a Compliant Policy for Your Life Sciences Organization
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21 CFR Part 11 Questions and Answers
Tips for Creating a Compliant Policy for Your Life Sciences Organization
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21 CFR Part 11 Powerpoint Presentation
Tips for Creating a Compliant Policy for Your Life Sciences Organization
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21 CFR Part 11 Policy
Tips for Creating a Compliant Policy for Your Life Sciences Organization
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21 CFR Part 11 Password Policy
Tips for Creating a Compliant Policy for Your Life Sciences Organization
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21 CFR Part 11 and GMP Compliance for Life Sciences Organizations
What You Should Know About Your Tools
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21 CFR Part 11 Excel Compliance
What You Should Know About Your Tools
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21 CFR Part 11 Electronic Records Electronic Signatures Validation
What Constitutes an “Electronic Signature” and How Your Company Can Remain Compliant
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21 CFR Part 11 Applicability Assessment
Title 21 CFR Part 11 Applicability Assessment Can Be Confusing
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21 CFR Part 11 Compliance for SaaS Cloud Applications
Understanding Title 21 CFR Compliance for SaaS Cloud Applications
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21 CFR Part 11 vs EU Annex 11
Know the difference: CFR Part 11 vs EU Annex 11
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21 CFR Part 11 Certification
GxP LMS Compliance with 21 CFR Part 11
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21 CFR Part 11 Section 11.10
Stop Guessing about LMS Compliance with 21 CFR Part 11.10
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FDA CFR Part 11 Compliance
Stop Guessing about LMS Compliance with 21 CFR Part 11
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21 CFR Part 11 Software Requirements
Stop Guessing about LMS Compliance with 21 CFR Part 11
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Understanding the Key Benefits of an FDA 21 CFR Part 11 Compliant LMS
There Are Many Benefits Offered by an LMS That Complies with FDA Standards
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Title 21 CFR Part 11
Get the Answers to the Most Common FAQs about Title 21 CFR Part 11 Compliance
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21 CFR Part 11 Tutorial
Not Clear on How an LMS Should Comply with 21 CFR Part 11? This Tutorial’s for You
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CFR Part 11 Testing
Stop Guessing about LMS Compliance with 21 CFR Part 11
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21 CFR Part 11 PPT
If Your Life Science Company Uses an LMS, This Guide Is for You
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21 CFR Part 11 on Electronic Records
Electronic Records Must Be Secure, Protected, and Compliant with FDA Rules
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21 CFR Part 11 Letter of Certification
Learn What Life Science Companies Should Know about Letters of Non-Repudiation Agreement
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21 CFR Part 11 Electronic Signature
E-Signature Requirements under 21 CFR Part 11 Apply to L&D
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21 CFR Part 11 Learning Management System
How 21 CFR Part 11 Impacts Life Sciences Security Standards
CFR Part 11 Definitions
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What is 21 CFR Part 11
A Guide for Life Science Organizations
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US 21 CFR Part 11
The Code of Federal Regulations Can Have Significant Impacts on Your LMS
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21 CFR Part 11 Labeling
Complying with the FDA’s Labelling Rules May Be Simpler Than You Think
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21 CFR Part 11 for HPLC
Get Answers to Your Questions about 21 CFR Part 11 for Companies Using High-Performance Liquid Chromatography
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21 CFR Part 11 Certification Training
Creating a 21 CFR Part 11 Certification Training Course Requires Specific Steps
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21 CFR Part 11
What Should a Life Science Company Look for in a 21 CFR Part 11 Compliant Learning Management System?
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21 CFR Part 11 Full Text
The FDA’s Rules and Regulations Impact Your Choice of LMS
CFR Part 11 Checklists
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Your 21 CFR Part 11 Compliance Checklist
Make Sure You’re Complying with the FDA’s Rules and Regulations
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21 CFR Part 11 PDF
Support Improved Learner Outcomes with a Validated LMS
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21 CFR Part 11 Examples
Breaking Down the FDA’s Rules for Better Understanding
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21 CFR Part 11 Compliance and Your LMS
Learn the Key LMS Features Necessary for 21 CFR Part 11 Compliance
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21 CFR Part 11 Checklist PDF
Need to Ensure Compliance with 21 CFR Part 11? This Checklist PDF Has You Covered