21 CFR Part 11

21 CFR Part 11 and EU GMP Compliance

Training records are nearly always reviewed during a regulatory inspection or audit for 21 CFR Part 11 compliance. Even for organisations that are not directly governed by the FDA, 21 CFR Part 11 is still an approved standard for electronic signatures, auditing, and record keeping. Regulatory bodies like the FDA also request that your Learning Management System (LMS) is validated for intended use.

21 CFR Part 11 training records inspection, CFR regulations

Are your training records always inspection ready?

21 CFR Part 11 Compliance, CFR regulations

Are you using electronic training records to save time and money?

FDA audit, CFR regulations

How much time does it need for you to prepare for an FDA audit?

21 CFR Part 11 training records, CFR regulations

Are your training records in compliance with 21 CFR regulatory requirements?

With an electronic system, training records are always up-to-date and inspection-ready. You won’t need to waste time to gather and check if your training records are up-to-date. An electronic system assures that everything is in order and easily accessed.

Comply with FDA 21 CFR Part 11

Checklist

Get answers to common questions about 21 CFR Part 11 to help your organization comply with the United States Food and Drug Administration (FDA) Title 21 CFR Part 11.

Download Checklist

White Paper

Learn about validation, e-signatures, versioning, reporting, and audit requirements. Read this whitepaper to see how NetDimensions can help you comply with FDA 21 CFR Part 11 and GxP equivalents.

Download White Paper

Unique Features

Auditing

All changes made to sensitive data within NetDimensions Learning LMS are tracked in the database along with information on the type of change, who made the change, and when. Types of changes include creation, update, and deletion of sensitive data.

Electronic training
records

With NetDimensions Learning LMS, electronic records are updated in real time for proactive compliance reporting. They are also quick and easy to access and report on, thus allowing organisations to be inspection-ready more effectively and efficiently.

Electronic signatures

Before every important operation in NetDimensions Learning, an electronic signature prompt appears, asking for user ID, password, and update meaning. These three parameters collectively form an e-signature. The user ID and password must be correct for the current user before the requested operation can be carried out.

Version control

NetDimensions Learning maintains content revisions for all compliance courseware and documentation such as Standard Operating Procedures (SOPs). This means that electronic training records are accurately updated with the exact version of each course taken, while course revisions can automatically trigger required training to maintain compliance.

Reporting

All audited data is presented as standard NetDimensions Learning LMS reports (for example, Audit Trail report and Audit Trail User Action report). This means users with appropriate permissions can view the audited information in various electronic formats like HTML, CSV, PDF, and Excel as with other standard system reports

Secure SaaS

NetDimensions is offering a qualified cloud hosting environment, available for clients who want to take advantage of NetDimensions' ISO 27001:2013 Secure SaaS services.

Software Validation

NetDimensions also provides consulting services for NetDimensions Learning to be validated in client environments worldwide for intended use along 21 CFR Part 11, 21 CFR Part 211, and 21 CFR Part 820, as well as EU GMP Annex 11 and EU GMP Part 1 requirements.

 
Contact Sales
Get in touch with a sales representative.