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.