Validation
Quality expertise + efficiency: optimizing and trusting system performance
It can feel daunting to now add validation onto the plate. With teams stretched to cover ongoing operations, a new system rollout, migration, there is limited bandwidth to address. There may not even be the expertise to do validation, and it would be time consuming to try to learn.
At 11 Compliance Consulting, 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.
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• 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)
- • Lifecycle management procedures
At 11 Compliance Consulting, our team maintains up-to-date knowledge of regulations and guidelines to provide premier validation services. We also stay up to date on the latest FDA guidance and industry trends. With a wide range of experience, we are well positioned to provide advice and recommendations for compliance improvements for enhanced system performance. We have helped our clients achieve excellent outcomes with their compliance.
Keeping you in compliance with a partner who understands the industry and systems
Use our validation services