21 CFR Part 11 (Title 21 CFR Part 11) Compliance in Highstage

Introduction

Highstage enables medical device companies to establish and maintain regulatory compliance as specified by the FDA with regards to FDA's 21 CFR Part 11. This is achieved by enabling mandatory signing authentication (electronic signature) by users when working with the system.

Configurations

Enable signing authentication

The following instructions guides you through the process of configuring Highstage to establish 21 CFR Part 11 compliance. When enabled, authentication will be prompted throughout Highstage.

Note: The following procedure requires administrator privileges in Highstage.

1. Set your Highstage user level to AdminWrite (required to make changes to Highstage system parameters).

2. Navigate to SYSTEM > Parameters > Security Parameters:

3. Check (✔️) SigningAuthentication (bit) to enable Signing Authentication in Highstage:

    

4. Fill out SigningAuthenticationSteps with a list of specific statuses where the user prompting the status change is required to use an electronic signature. Options include Freeze, Review, Accept, Approval, and Approve:

5. Fill out SigningJustificationSteps with a list of specific statuses where the user prompting the status change is required to provide a justification (associated role for performing the activity). Options include Freeze, Review, Accept, Approval, and Approve:

6. Click Reset in Highstage for all changes to take effect.

Disable signing authentication for a specific subtype

Once signing authentication is enabled, it will be applied to all items in Highstage. It is possible to disable signing authentication on specific subtypes individually so that any progression on items of that type will not prompt authentication.

This is relevant when there are types that are not subjected to regulatory compliance.

To disable signing authentication on items of a specific type:

1. Navigate to Documents > Types and click on the relevant subtype to navigate to its dedicated page.

2. Expand the Options section and check the DisableSignAuth checkbox:

3. Click Reset in Highstage for all changes to take effect.

Success! You have successfully disabled signing authentication for a specific subtype.

Example

The following example utilizes the signing authentication configuration as shown below:

Whenever an item (e.g. Document, Part, Device) is prompted for a status change (e.g. freezing a document, or prompting a review or approval, or accepting or rejecting a review/approval) - then the user performing the action will be required to enter their user credentials as well as provide a selection of role of context for doing so:

The default list of available justification roles are as shown below:

The list of available justification roles can be configured to suit your exact needs by making changes to the snippet below and placing it directly in custom.schema.xml (or in any included schema file):

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    <type name="doc">
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        <column name="_justification"  values="Author;Manager;Responsible;Quality Director"/>
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    </type>

Tip: You can freely change the type (e.g. doc, part, type, action, device) or move it to a subtype to alter the justification roles (values) independently for items of that type.

Result:

freeze;review;accept;approval;approve