Quality Documents¶
The Quality Documents module governs every controlled document in your operation — SOPs, work instructions, policies, form templates, specifications, protocols, plans, manuals, and job descriptions. If a document affects product quality, safety, or efficacy, it belongs here. Quality Documents is the spine of QStack: records, training, deviations, and audits all reference the documents you manage in this module.
You'll use this module if you're an Author or Owner drafting a procedure, a Reviewer or Approver signing off on one, or anyone in the organization reading the current effective version of a document you need to follow.
Document types¶
QStack supports a fixed list of document types. Each type has a default periodic review cycle, which your Org Admin can override per document type at onboarding.
| Type | Typical use | Default review cycle |
|---|---|---|
| SOP | Standard Operating Procedure — how you do something routinely | 24 months |
| WI | Work Instruction — step-by-step for a single task | 24 months |
| Policy | High-level statement of intent | 36 months |
| Form | Blank evidence template, paired with Quality Records | 24 months |
| Specification | Product, material, or method spec | 24 months |
| Protocol | Validation/qualification/study protocol | One-shot, no recurring review |
| Plan | Validation Master Plan, Quality Plan, etc. | 36 months |
| Manual | Quality Manual, Site Master File | 36 months |
| Job Description | Per-job-function description | 24 months |
Every document gets a tenant-unique document number auto-assigned by type
(for example SOP-0001, WI-0001). The numbering format is set once at
onboarding and doesn't change afterward.
Note
A Form document governs a record template in Quality Records. Publishing a new Form version publishes a new record-template version — records always render against the template version they were created under, even after the template changes later.
Document lifecycle¶
Every controlled document moves through the same fixed set of states:
Draft → In Review → Approved → Effective → Superseded / Retired
| State | What it means | Who can act |
|---|---|---|
| Draft | Being written; not visible to general staff | Owner edits and uploads new PDF versions |
| In Review | Sent to reviewers and approvers for signatures | Reviewers/approvers sign; Owner cannot edit |
| Approved | All signatures collected, not yet in force | Owner sets the effective date |
| Effective | Currently in force — staff must follow this version | Read-only except for transition |
| Superseded | Replaced by a newer effective version | Read-only, retained for the retention period |
| Retired | No longer needed (process discontinued) | Read-only, retained for the retention period |
A document can only move from In Review back to Draft if a reviewer rejects it with comments — every other transition moves forward.
Author a new SOP¶
- Click New Document and pick a type. QStack proposes the next document number for that type — accept it or, if your tenant allows, adjust it.
- Fill in the metadata: title, scope, related documents, default reviewers and approvers, and a target effective date.
- Upload your first draft as a PDF. QStack doesn't edit document content — write the SOP in Word or Google Docs and upload the finished PDF.
- Click Send for Review. The document moves to In Review.
Warning
You can't send a document for review until it has a document number, a document type, an owner, at least one approver, and an uploaded file. QStack blocks the transition until all of these are in place.
Send a document for review and approval¶
Once a document is In Review:
- Each reviewer gets an email and an inbox entry.
- A reviewer opens the document, reads it, and either:
- Signs with the meaning Reviewed and approved — the document moves on to the next signer, or
- Rejects with comments — the document returns to Draft, and the comments are recorded for the Owner to address.
- Approvers sign with the meaning Authorised for release.
- When the last required signature lands, the document automatically moves to Approved.
See Electronic Signatures for how signing meanings and re-authentication work.
Make a document Effective¶
- As Owner, pick an effective date — today or a future date.
- Click Set Effective. QStack asks whether this document supersedes an existing one; if so, pick the predecessor.
- On the effective date (immediately, if you picked today):
- The document moves to Effective.
- The predecessor, if any, moves to Superseded.
- Training assignments fan out automatically to every person whose job function requires this document — see Training.
Review a document on schedule¶
QStack calculates the next review date as effective date plus the review cycle for the document type (or an override you set on the document).
- 90 days before the review date, the Owner gets a reminder.
- 30 days before, Quality role holders get a reminder too.
- After the review date passes, the document shows up on the "Overdue review" dashboard tile.
When the review comes due, the Owner does one of two things:
- Confirm no changes — sign an attestation; the next review date advances by one cycle and nothing else changes.
- Issue a revision — draft a new version, which follows the full lifecycle above and supersedes the current version once it reaches Effective.
Retire a document¶
- As Owner, request retirement with a written justification (typically because the process it describes is being discontinued, not replaced).
- A Quality role holder approves the retirement with a signature.
- The document moves to Retired.
- Anyone who has this document in their training requirements is notified; Quality decides whether replacement training is needed (often not, since the process itself is going away).
Search for a document¶
The search bar finds documents by:
- Document number (exact match)
- Title (full text)
- Free text inside the document content — QStack extracts text from uploaded PDFs
- Type, status, or owner
- Effective date range
- Documents linked to a specific job function ("what does a QC Analyst need to know?")
Version history¶
Every uploaded PDF is kept as a version. The "current" version is the one currently bound to the document; older versions stay accessible to anyone who can view the document. Each version records who uploaded it, when, the file hash, file size, and page count. Once a version has been bound to a state transition — for example, it was the file in force at the time of approval — it's permanent and can't be replaced.
What QA gets¶
- A single screen listing every Effective document with its owner, last review date, and next review date.
- An "Action needed" tile showing documents in review awaiting your signature.
- A "Backlog" tile of documents past their review date.
- CSV/PDF export of the full controlled-document register for audit preparation.
What this module doesn't do¶
- It doesn't edit document content — author in Word or Google Docs and upload the PDF.
- It doesn't generate redlines — produce the redline outside QStack and upload it as a new draft version.
- It doesn't enforce a particular document template format.
- It doesn't deliver training itself — Training does that; this module only triggers the assignments.