Change Controls

In GxP industries, Change Control is a structured process used to manage, document, and implement changes in a controlled and systematic manner - this ensures that any modifications have been evaluated for their potential impact on quality and compliance. This is often a separate from that has to be filled out.

Change controls is a type of entity in Seal that replicates a change control form. In Seal, there is no need for an external change control form - Change Controls are built-in into the platform.

In Seal, any type of change - whether edits to a document, or a configuration change - will entail creating a new draft and publishing an entity. Change control is integrated into the Seal platform — it is mandatory that users must fill out a change control form, before anything can be published.

How does it work?

1

Create new draft and make changes

2

Create change control

Instead of Publishing, users will be able to -> users will be navigated to a new page with a Change Control form.

3

Populate change control form

The change control form is populated just like a change control form, with fields such as (but not limited to):

• Changes made, and change justifications

• Risk Assessment

• Change action items

If your organisation contract includes change control automations, the above fields will be automatically filled out based on the changes you have made in Step 1.

Can I change the change control template to fit my organisational needs? Yes, it is by design that the change control behaves like any other procedure. Users are able to make changes, publish, and send new versions for training.

4

Validate Changes

Tests will be conducted to ensure that any changes made will not affect or break the wider Seal system. Note that these tests are conducted on a test environment with the deployed changes.

5

Send change control for approval

Once the change control is satisfactory, send the change control for approval.

6

Publish and Deploy changes

Once the change control has been approved, the changes are deployed. The validation tests are run and and the changes made are now live on the system.