Validation
Our validation services ensure you have the utmost confidence in your system’s performance. We design our validation processes around your documented business process. Our team focuses on ensuring your system is validated while taking the least burdensome approach, utilizing risk to mitigate testing while not losing sight of data integrity and system security.
- • Verification of compliance with FDA 21 CFR part 11 and EMA Annex 11 pertaining to electronic records.
- • Development of Validation Documentation
- • Validation Plan
- • User Requirement Specifications
- • System Specification (Functional, Configuration etc.)
- • Installation, Operational, and Performance Qualifications.
- • Risk Assessments and migration strategies.
- • Final validation report
- • Vendor documentation assessment and acceptance strategy
- • System usage procedures (see Training)
Our interdisciplinary team maintains up-to-date knowledge of regulations, and guidelines to provide premier validation services. With a wide range of experience it puts us in a great position to provide advice and recommendations for compliance improvements for enhanced system performance.
Use our validation services