Get more visibility into your imaging data. Flywheel Validated Core provides end-to-end 21 CFR Part 11 compliant software so you can minimize error, save time and confidently leverage auditable results for regulatory submission.
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Validated Core provides the same features of Flywheel Core in a fully-documented 21 CFR Part 11 compliant system that allows you to document workflows, manage fully-provenanced data & imaging endpoints, and submit data packages to regulatory bodies.
Flywheel Core can be augmented with the Audit Trail module to track all changes made to your imaging datasets. Flywheel Validated Core gives you full 21 CFR Part 11 compliance, with project locking and e-signatures, plus biannual support hours with a customer-hired auditor.
Ensure a secure environment that can be used for compliant research.
Access compliance documentation and data management policies for more efficient submission.
Define the day-to-day support and workflow migration you need to seamlessly execute standard operating procedures.
Get access to experienced data scientists who can consult with you and develop Gears specific to your needs.
A research laboratory needed a way to conduct a complex Phase 3 clinical trial to assess the efficacy of a new treatment in participants with diabetic retinopathy. With Flywheel Validated Core, researchers in dispersed clinical sites are uploading ophthalmic images and data from multiple sites into one, centralized location for comprehensive reader review. Everything done in the trial is completed with audit trails to achieve FDA compliance and ensure any changes to the data are traceable.
When you achieve compliance & 21 CFR Part 11 data integrity with a validated platform, your most valuable data can be stored properly and reused to create treatments faster.
