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
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Access to extra product features required for compliance, audit readiness and locking down data.
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All features enabled by default are validated by Flywheel and independently audited.
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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 Digital Signature | MFA based identity verification and signing of Project Lock/Unlock requests. |
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 releease and validation documentation necessary for customer to maintain system validation and audit readiness. |
Note
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
This module should only be enabled on a new Flywheel instance, and once enabled, disabling is not supported. While disabled, Audit Trail records are not created and thus the continuity of those records are broken.
Standard Flywheel Core features are also enabled on Validated Instances, which compliment its validation and audit readiness capabilities.
Resources
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Project Locking – [available with a future release version]
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MFA Digital Signatures - [available with a future release version]