Computer Systems Governance and Validation

The FDA has clearly defined system validation regulations described in 21 CFR Part 11. During inspections, your electronic systems will be scrutinized for compliance to these regulations. Activities such as validation of new systems or remediation of existing systems to identify gaps can greatly reduce your compliance risk during an audit.  UL EduNeering's services can help you meet these regulations with services that include guided templates for companies that require UL validation documentation, test scripts and validation plans; or we can simply review your documents to ensure they meet FDA expectations.

Contact UL EduNeering's Advisory Services team at 609.627.5300 or email to learn how we can help you meet your 21 CFR Part 11 System Validation regulations.

  • Validation Support

    UL EduNeering can assist your team with the validation effort related to both installed and cloud applications (ERP, DMS, LMS, SCMS, QMS, etc.) to meet the critical system validation regulatory requirement for any computer system that is used to store electronic records, according to FDA 21 CFR Part 11.10(a) and Annex 11 Paragraph 4.

  • Validation Audit

    UL Eduneering provides 21 CFR Part 11 computer system validation audits to assist with the review of current validation documentation, provide gap assessments and assist you with preparing and executing remediation plans.

  • System Governance

    UL EduNeering can help develop a well-defined and executed system governance strategy which is essential to the successful operation and maintenance of your LMS, ensuring that your LMS implementation aligns with the goals set forth by your organization.

  • UL EduNeering's Partnership with FDA Extended Until 2019

    The FDA's Cooperative Research and Development Agreement (CRADA) with UL EduNeering has created a collaborative partnership between the two organizations, resulting in courses developed with, and used by FDA inspectors and industry professionals worldwide.

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  • UL EduNeering maintains an Exclusive Compliance Partnership with AdvaMed

    UL serves as AdvaMed's exclusive online compliance partner, providing its members with educational resources to maintain regulatory compliance and professional knowledge. Those programs accommodate the needs of both emerging companies and well-established device firms.

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  • Brandon Hall Excellence in Technology Awards

    For SIX years running, UL has won an Excellence in Technology Award from Brandon Hall.  These awards were presented by Brandon Hall Research, one of the leading research firms in training and development.

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