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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Draft → In Review → Approved → Effective → Superseded / Retired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Superseded Replaced by a newer effective version Read-only, retained for the retention period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

  1. 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.
  2. Fill in the metadata: title, scope, related documents, default reviewers and approvers, and a target effective date.
  3. 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.
  4. 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:

  1. Each reviewer gets an email and an inbox entry.
  2. A reviewer opens the document, reads it, and either:
  3. Signs with the meaning Reviewed and approved — the document moves on to the next signer, or
  4. Rejects with comments — the document returns to Draft, and the comments are recorded for the Owner to address.
  5. Approvers sign with the meaning Authorised for release.
  6. 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

  1. As Owner, pick an effective date — today or a future date.
  2. Click Set Effective. QStack asks whether this document supersedes an existing one; if so, pick the predecessor.
  3. On the effective date (immediately, if you picked today):
  4. The document moves to Effective.
  5. The predecessor, if any, moves to Superseded.
  6. 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

  1. As Owner, request retirement with a written justification (typically because the process it describes is being discontinued, not replaced).
  2. A Quality role holder approves the retirement with a signature.
  3. The document moves to Retired.
  4. 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.