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Lifecycle and approval

Move a controlled document from draft to released and, eventually, to retired. Each transition is performed from the document's detail page, gated by the document's current state and your role, and recorded in the audit trail. Approval and obsoletion also require an electronic signature.

Who this is for

Administrators. The author or an admin can submit a draft; only a Quality Admin (Quality Admin or Corporate Admin) can approve, reject, make effective, or mark obsolete.

The transitions at a glance​

draft  ->  in_review  ->  approved  ->  effective  ->  superseded / obsolete
ActionFrom stateWho can do itResult
Submit for reviewDraftAuthor or adminIn review
Approve (with signature)In reviewQuality AdminApproved
Reject (with reason)In reviewQuality AdminBack to Draft
Make effectiveApprovedQuality AdminEffective (prior version superseded)
Mark obsolete (with signature)Effective or SupersededQuality AdminObsolete

The action buttons appear only when your role and the document's state allow them, so you never see a control you cannot use.

Every version walks this path, including revisions​

The table above describes a version, not only the first one. A revision of a published document starts as a draft and travels the same route, which is why creating one changes nothing for readers until it is made effective.

Two consequences are worth knowing:

  • A revision in review does not change the document's own status. The published SOP stays Effective and readable, and everybody obliged to acknowledge it keeps that obligation, while the next revision is being reviewed. The document's status follows its current version, not the one being prepared.
  • Only one revision travels at a time. While a revision is in review or approved, the option to start another is not offered. Withdraw it or let the decision land first.

Where you find each action​

The version transitions (submit for review, approve, reject, and make effective) live on the version's own card in the version history. Open the document, expand the revision you are acting on, and pick the language. The same card is where each translation moves through its own review, so a version and its transitions always sit together. Mark obsolete is a whole-document decision, so it stays at the top of the detail page next to the acknowledgement button.

Screenshot pendingDocument detail page with the current version card expanded, showing the lifecycle action buttons

Submit for review​

When a draft is ready, the author or an admin submits it. The document moves to In review and is stamped with who submitted it and when. This opens a review task for the Quality team. See the Quality review and audit area.

A submit_document_for_review event is recorded. If the audit record cannot be written, the submission is reverted and the document stays in Draft.

Find everything waiting for you in one place

Submitting a document (or a translation) puts it on the Quality review queue, alongside pending training versions. A Quality Admin can work the queue as a single inbox and filter it to Pending documents, instead of opening documents one by one to find what needs a signature. The Knowledge Base also shows an Awaiting approval count that links straight to the queue. The queue card carries the same Approve, Reject, and Make effective actions as the document detail page.

Approve with an electronic signature​

A Quality Admin reviews the submitted document and either approves or rejects it. Approval requires an electronic signature:

  1. On the In-review document, select Approve.
  2. The signature dialog opens. Confirm your identity and apply your signature.
  3. The document moves to Approved.
Approval is an electronic signature and is immutable

The signature, the signed statement, the signer, the timestamp, and the network address are captured as an append-only approval record. The network address (signed_ip) is recorded server-side from the request itself. It is never sent by your browser and never accepted from the client. Approval records cannot be edited or deleted. This is what makes the approval defensible under 21 CFR Part 11. See the Compliance area.

Reject with a reason​

If the document is not ready, the Quality Admin rejects it instead. Rejection requires a reason of at least 10 characters. The document returns to Draft so the author can revise and resubmit. The rejection is recorded in the audit trail.

Screenshot pendingReject dialog with the required reason field

Make effective​

An approved document is signed off but not yet released. A Quality Admin makes it effective to release it:

  1. On the Approved document, select Make effective.
  2. The document moves to Effective and is stamped with its effective date.

When a version becomes effective, any previously effective version of the same document is automatically marked Superseded, so there is never more than one effective version. This step is what actually releases the change: it points the document at the new version, refreshes what readers open and what the assistant searches, and notifies everybody obliged to read the document. A make_document_effective event is recorded; if the audit fails, the whole promotion is reverted, including the previously effective version.

Once effective, the document is visible to its audience and can be acknowledged. See Acknowledgements.

Translations follow the same lifecycle, per language​

A translated variant of a document goes through the same steps: it starts as a draft, is submitted for review, approved with an electronic signature, and made effective. Two rules are specific to translations. First, the person who created the translation cannot approve or reject it; a second person must sign. Second, making a translation effective releases it only for its own language: it supersedes the previous effective translation in that language and never changes the document's governing version. Superseding the master revision does not delete existing translations; they stay readable and are flagged as outdated until a new translation of the current revision is approved.

Mark obsolete​

When a document should no longer be used, a Quality Admin retires it. This is available from an Effective or Superseded document.

  1. Select Mark obsolete.
  2. Enter a reason of at least 10 characters.
  3. Confirm.

The document and its versions move to Obsolete. The content is preserved for the historical record; the obsolete state is the signal that it must not be used. An obsolete_document event is recorded, and the obsoletion is reverted if the audit cannot be written.

Mark obsolete instead of deleting referenced documents

If a document is used as a source by any training, it cannot be deleted. It must be made obsolete. Obsoleting preserves the traceability between the document and the training evidence that relied on it. See Deleting documents and Used by trainings.

Editing during the lifecycle​

Editing a content document's body is allowed only in Draft or Effective. It is blocked in In review, Approved, Superseded, and Obsolete so that the body cannot change out from under an approval. Editing an effective document creates a new draft version that goes back through review. See Creating documents for the edit flow.