Review requirements & checks

Draft entities must pass both Reviews and Checks before they can be published.

Review requirements

Review requirements can be set on a template or a type. If requirements are set on a template, they will override any set on the type.

These requirements must be met when a relevant entity is sent for review. When configuring requirements, you can select a user group and specify the number of users from that group required for approval. Alternatively, you can select an individual user. Requirements can also be renamed and reordered. Reordering controls how requirements are displayed; it does not force reviewers to approve in that order.

Review phases are not sequential. Once a change set is sent for review, users in any required phase can approve in any order. The change set is ready to publish only after every required phase has enough approvals and all Checks have passed.

Each review phase carries a signature meaning (e.g. Approval, Review, Responsibility, Authorship, Acknowledgement, or a custom value) that satisfies 21 CFR § 11.50. The meaning is displayed as a read-only label when the reviewer signs off and is permanently recorded in the audit trail.

Changes to review requirements on a type or template affect all entities, both existing and future. The requirements from the active version of the type or template are used, so these changes are applied only after the type or template is published. For existing entities, the updated requirements must be met the next time the entity is sent for review.

When a change set contains entities with different review requirements, the requirements are merged to select the most conservative option, ensuring all conditions are met. For example, if one entity requires one approval from the “Quality” group, and another entity in the same change set requires two approvals from the “Quality” group and one from the “Legal” group, the change set will require two approvals from “Quality” and one from “Legal”.

When requesting reviews, operators can add additional review roles or make existing requirements stricter (e.g., by increasing the number of required approvals). While added roles can be removed, requirements set on the template or type cannot be removed or made less strict. When requesting reviews, you can choose specific users from each group to notify, or notify all users in a group by selecting ‘Notify all’. If a group has only one user, that user will be notified automatically.

Reminders

Seal does not automatically chase reviewers. If a change set has been sent for review and a reviewer has not yet approved, no follow-up is sent on its own — and a pending review never times out, auto-approves, or escalates.

The person who requested the review can send a reminder manually from the review panel. Use Send reminder next to an individual reviewer, or Send all reminders to notify everyone with an outstanding approval at once. A reminder re-sends the review request email to reviewers who have not yet responded.

Checks

What is a Check?

Checks are automations that must pass — meaning they must run successfully, without errors — before a document can be published or sent for review.

If a Check fails, you are not able to proceed with publishing.

How do I configure checks?

Checks can be set on both Types and Templates, giving you flexible control over how and where your validation rules apply.

• Setting a Check on a Type will enable you to set Checks for all templates and instances of the type

• Setting it on a Template will apply it to all instances of that specific template. To add a Check, navigate to the Instance tab in the entity and select your automation.

During a review, you’ll also be able to see which Checks are applied right within each change set, so you always know what’s being enforced and where.

How to Write Checks

Seal includes an AI Copilot to write code for you. Navigate to the ‘Copilot’ tab in the sidebar and write a prompt to describe what you need.

See Formulas for the per-field expression surface.