Controlled Document Lifecycle

What QualityDocs manages

QualityDocs manages drafting, review, release, the ready-for-training step, effectiveness, periodic review, issuance, and withdrawal of quality-system documents. Versions, workflows, and electronic signatures come from the platform document capability.

The document lifecycle is the main line. Change control, the handoff to training, periodic review, read and understood, and controlled copies all hang off that line. They do not invent a second set of document states.

A change to a product, process, or supplier uses QMS change control. That record and a document change control may reference each other. They are not the same control record.

States

An upload that has not finished, and a document that is staged, belong to the platform. They are not states on this path.

Two ways into Ready for Training

If the document is not on any control record's release list, approval of the review moves it straight to Ready for Training.

If it is already on a control record's release list, approval of the review moves it to Pending Change Control Approval. Approving the control record does not change the document state. It writes the proposed effective date. On the proposed implementation date the system moves the document to Ready for Training. A document marked for obsolescence stays effective and becomes obsolete on that date. It does not pass through Ready for Training.

When a new version moves from Ready for Training to Effective, the previous effective version of the same document becomes Superseded. The document owner makes it effective. The proposed implementation date does not do that by itself.

Once change control is enabled, an effective document leaves Effective in only two ways: a newer version supersedes it, or change control obsoletes it on the proposed implementation date.

What hangs off the lifecycle

• Release list: adding the current effective document to a control record's release list creates a draft, and that draft appears on the list.
• Obsolescence list: the current effective version stays on the list and stays Effective until the proposed implementation date, when it becomes obsolete.
• Training: after the document is Ready for Training or Effective, the training matrix can issue assignments. An unfinished impact assessment does not block those states.
• Read and understood: assigned to trainees on the document when the read is outside the training matrix. After Training is enabled, matrix reads are not also sent as read-and-understood tasks.
• Periodic review: only for a document that already has an effective version. The review does not open a new draft.
• Controlled copy: create a copy request on the effective document. The object type distinguishes the kind of copy. After approval the copy is generated. Copies still in use are recalled when that version is superseded or obsoleted.
• QR code: always opens the latest effective version of that document.

Handoff to training

Vault documents are the source of training materials. Do not expect the matrix to issue a version that is still in draft or in review. Training issues by role after the document is Ready for Training or Effective.

Where to start

Use Document Control and Change Control in Quality navigation.

Typical multi-document path

1. Change manager creates document change control with release/obsolete lists and implementation date.
2. Authors submit drafts; QA reviews; documents wait for change control approval if on the list.
3. Approver approves the control; on the date, release list → Ready for Training, obsolete list → Obsolete.
4. Owners make effective; Training updates assignments.

FAQ