Configure electronic signatures & sign-off

Make controlled states mean something — gate them behind approval, define who signs and what each signature means, and confirm the Part 11 signing act records an attributable, meaning-bearing signature.

A controlled record isn’t truly controlled until reaching its locked state requires the right people to sign, in the right order, with the meaning recorded. This guide wires that up across three pieces: the controlled states that demand sign-off, the approval chains that define who signs and what each signature means, and the signing act itself. It builds on a workflow and item type that already exist — see Configure item types, fields & workflows — and on the data-integrity controls from Set up a compliance framework.

Gate the controlled states

A controlled state is a locked, approved condition. Sign-off is what should stand between a record and that state.

Before you start The item type's workflow exists, with its states and transitions defined.

In the workflow, mark the states that are controlled — the locked conditions that must not be reached casually (see Workflows).
Identify the transitions into those controlled states — these are the points that should require approval.

Result Reaching a controlled state becomes a deliberate, gated event rather than an ordinary edit. See Controlled states & workflows.

Build the approval chain

An approval rule defines the sequence of sign-offs a record must collect before a gated transition can complete.

Before you start Open Administration and go to Approval rules.

Create an approval rule as a sequence of ordered approval steps.
For each step, choose who signs — a specific user, a group, or the item owner — and how many approvals it needs.
Set the meaning each signature carries, with a custom label where your terminology differs, and mark the step always required or optional.
Enable the rule so the platform enforces it wherever it applies.

Result Sign-off follows your process — defined centrally, enforced everywhere, not arranged ad hoc per record. See Approval rules.

Confirm the signing act

The definition lives in admin; the signing happens against it. Confirm the two halves connect.

Route a record into one of the gated transitions you set up.
Confirm the signer must re-authenticate, state the meaning of the signature, and approve or reject — the Part 11 signing act.
Confirm the signature, its meaning, and the signer's identity are recorded against the record and its history.

Result Every controlled transition carries an attributable, meaning-bearing electronic signature. The user's side of this is covered in Approvals & e-signatures.

Note Data integrity is what makes a signature mean anything — chain hashing binds it to a record that can't quietly change underneath it, so configure those controls first in Set up a compliance framework. Where your process demands independence, design the chain for separation of duties so the signer isn't simply approving their own work.

Where to go next

In-flight approvals against these rules are monitored in Pending approvals. To pull controlled records, verification, and signatures together into an audit-ready package, see Verify compliance & produce evidence.