Supporting validation requirements can be a challenge for many organizations trying to ensure compliance with their learning system while managing updates in the cloud. GP Strategies® knows that validation is complex—this is why we have partnered with SumTotal Systems to provide compliance and validation services and support, helping reduce your risk of noncompliance while increasing your time to value. GP Strategies has implemented hundreds of compliant related solutions and is considered one of the world’s leading authority on FDA 21 CFR Part 11 system validation.
Validation and Predicate Rules: How Does It Impact Me?
A predicate rule is any FDA regulation that requires companies to maintain records and submit information to the agency as part of required compliance. Training records covered by predicate rules must comply with “good practice” quality guidelines and regulations (GxP): Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), and Good Laboratory Practices (GLPs). If your learning system maintains records in support of GxPs, parts of FDA 21 CFR Part 11 apply and you could be at risk of noncompliance, remediation, and costly fines.
Experience Supporting Highly Regulated Industries
GP Strategies has more than 20 years of experience supporting learning and technology solutions for highly regulated organizations. With extensive experience coordinating with Quality Assurance and Compliance departments, GP Strategies specializes in supporting organizations with highly complex learning requirements. Utilizing our detailed platform and quality assurance experience, GP Strategies has provided learning technology services for a myriad of highly regulated organizations, including healthcare organizations, life sciences corporations, and pharmaceutical companies. Below are topics and areas that we can help you with:
System Validation Documentation
- Validation master plan/risk assessment
- User requirements
- Functional requirements
- Traceability matrix
- Installation Qualification (IQ) (Install)
- Operational Qualification (OQ) (Test)
- Performance Qualification (PQ) (Monitor)
- Validation summary reporting
- Ongoing system health checks
- Product release review sessions