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 EduNeeringInquiry@UL.com to learn how we can help you meet your 21 CFR Part 11 System Validation regulations.
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.
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.