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FDA 21 CRF Part 11


FDA 21 CFR Part 11 LMS Validation

NetDimensions LMS is focused on helping companies and organizations in high-consequence industries where operational and compliance requirements are particularly complex. Having been named the world’s best compliance LMS, NetDimensions LMS supports auditing, e-signatures, version control and reporting capabilities to meet 21 CFR Part 11 compliance requirements for electronic records.

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 organizations 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 LMS is validated for intended use.

Are your training records always inspection ready?

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

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

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.

FDA 21 CFR Part 11 Compliance - 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.

NetDimensions LMS & 21 CFR Part 11 Compliance: Unique Features

  • Auditing

    All changes made to sensitive data within NetDimensions 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 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 organizations to be inspection-ready more effectively and efficiently.

  • Electronic Signatures

    Before every important operation in NetDimensions LMS, 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 LMS 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 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 LMS offers a qualified cloud-hosting environment, available for clients who want to take advantage of our ISO 27001:2013 Secure SaaS services.

FDA Software Validation

We also provide consulting services for the LMS 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.

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