Validated Instance - Overview
Introduction
This document provides an overview of the product features included with a Flywheel Validated Instance.
A Validated Instance is a Flywheel site that includes the necessary features and support services to ease the burden of operating a Flywheel instance that is validated and audit ready for compliance with 21 CFR part 11 regulations, as well as Good Clinical Practice and related standards.
Value
- Access to extra product features required for compliance, audit readiness and locking down data.
- All features enabled by default are validated by Flywheel and independently audited.
- Access to the Flywheel support services and materials necessary for customer validation and audit of the Flywheel Instance.
Features
These are the extra product features included with a Flywheel Validated Instance.
| Name | Description |
|---|---|
| Audit Trail | A record of data changes (who, what, where, when) that can be browsed and exported. |
| Delete Reason | All deletions of data within projects, as well as projects themselves require a delete reason to be specified. |
| Project Locking | The locking and unlocking projects prevents all changes to project data. |
| MFA Electronic Signature | MFA based identity verification and signing of Project Lock/Unlock requests and task completion. |
| E-Signatures for Tasks Manager | Electronic signature process for task completion, including multi-factor authentication, verification, and audit trail integration. |
Extra support services that are available.
| Name | Description |
|---|---|
| Self Validation | For features not validated by Flywheel, a customer may elect to enable them and self-validate. |
| Audit Support | Flywheel will make staff and materials available to satisfy audit by customer. |
| Documentation | Access to additional Flywheel release and validation documentation necessary for customer to maintain system validation and audit readiness. |
Note
Validated deployments always start with a clean, fully controlled baseline. This ensures (i) complete audit history, (ii) consistent configuration control, (iii) data collected in an instance created under validation plans and SOPs, and (iv) defensibility during sponsor or regulatory review.
A dedicated Flywheel Validated Instance should be deployed and used for only the projects which require this functionality. This is due to the additional system resources required for capturing, retaining, and providing access to the detailed record of every data change within the Audit Trail Record.
Note
To maintain data integrity and full traceability, Audit Trail must be activated before regulated work begins on a new Flywheel instance. This ensures that every action, data change, and user event is captured from the very start of your workflow in a validated instance. So this module should only be enabled on a new Flywheel instance, and once enabled, disabling is not supported.
Standard Flywheel Core features are also enabled on Validated Instances, which compliment its validation and audit readiness capabilities.