Document Control module

Document control & SOP management software for accredited labs

Replace your shared-drive SOP folder with a real controlled document system. Multi-version uploads, multi-reviewer approval, per-staff acknowledgment tracking, scheduled periodic reviews, and a compliance score that mirrors what your auditor will look for. Every file checksummed, every change attributable.

CalibDue Document Control dashboard showing compliance score, total documents, drafts pending, documents in review, overdue and due-soon reviews, pending acknowledgments, and recent document activity

Document Control dashboard — compliance score, in-flight reviews, pending acknowledgments, and activity feed.

What is document control software for laboratories?

Document control software replaces shared drives and email approval threads for managing a lab's controlled SOPs, policies, work instructions, and forms. ISO 15189, CAP, CLIA, and UKAS all require version control, approval evidence, staff acknowledgment of new versions, and scheduled periodic review — and most labs do all of this with file names like 'SOP-001_v3_FINAL_REVISED_jan2026_actually-final.docx'.

CalibDue gives every document a controlled register entry with metadata (number, title, category, department, owner, review interval), supports multi-version uploads with SHA-256 file checksums, runs each new version through a multi-reviewer approval workflow, notifies assigned staff to acknowledge the approved version, and schedules periodic reviews so SOPs never go stale. Everything is logged in an audit trail — no version, approval, or acknowledgment can be edited or backdated without a record.

What CalibDue's Documents module does

  • Controlled document register with number, title, category, department, owner, review interval
  • Multi-version uploads with SHA-256 file checksum on every upload
  • Multi-reviewer approval workflow: auto-approves on consensus, auto-rejects on any rejection
  • Admin force-approve override with mandatory reason captured
  • Per-version acknowledgment tracking: self, on-login prompt, or bulk admin acknowledge
  • Periodic review records: 'no changes', 'revision needed', or 'withdrawn'
  • Per-document acknowledgment compliance: pending vs acknowledged per staff member
  • Document compliance score on the dashboard
  • Signed 15-minute download URLs — no permanent open file exposure
  • Soft-delete with activity log — nothing is ever truly lost

Built for your accreditation standard

The Documents module enforces the right rules per standard automatically. Switch standards per lab; the rules switch with you.

ISO 15189 Medical laboratories

Controlled documents with version history, approval evidence, staff acknowledgment, and periodic review at defined intervals — all built into the module.

CAP College of American Pathologists

SOPs reviewed at the required cadence with documented approvals; staff acknowledgment of new versions retained as evidence.

CLIA Clinical Laboratory Improvement Amendments

Procedure manuals controlled with version history; staff trained on and acknowledging current versions; document changes traceable.

UKAS United Kingdom Accreditation Service

ISO 15189-aligned controlled documents with checksummed file versions; configurable retention with floor enforcement.

Common questions about documents

How does the multi-reviewer approval workflow actually work?

When you submit a new document version for review, you assign one or more reviewers. Each reviewer independently approves or rejects with optional comments. The version auto-approves when every assigned reviewer has approved (consensus), and auto-rejects the moment any reviewer rejects. Admins can force-approve in exceptional cases — a reason is mandatory and is captured in the audit log. Approved versions become the controlled current version; previous versions are retained for history.

What's the difference between acknowledgment methods?

CalibDue records the method used to acknowledge each version: 'self' (the user clicked acknowledge in their own session), 'on_login' (the system prompted on login and the user acknowledged), or 'bulk_admin' (an admin marked acknowledgment after, for example, a training session where staff signed off in person). The method is shown in the audit trail so reviewers can verify the integrity of the acknowledgment record.

How are periodic SOP reviews handled?

Every document has a review interval (e.g. annually, every two years). Before the next review is due, the document owner receives a reminder. The reviewer records the outcome: 'no_changes' (the SOP is still correct as-is — review date is reset), 'revision_needed' (a new version must be drafted — the document is flagged), or 'withdrawn' (the SOP is no longer in use — soft-deleted with reason). All review records are retained for audit.

Are document files stored securely?

Every upload is stored with a SHA-256 checksum so tampering is detectable. Files are not served from a public URL — every download is a short-lived signed URL that expires after 15 minutes (locally) or an AWS presigned URL (in production with S3). Soft-deletes are recorded in the activity log; nothing is ever truly removed without an audit trail.

Is the document register exportable for an auditor?

Yes. The Document Register PDF Export lists every active document with number, title, category, current approved version, last review date, next review date, acknowledgment statistics, and the owner. It's the document register an ISO 15189, CAP, CLIA, or UKAS auditor will ask for, ready in one click.

Your next audit starts today.

Calibration, training, EQA, maintenance, and documents — one platform, one readiness score. Join the waitlist and get early access when we launch.

Be the first to know when CalibDue launches.

ISO 15189 · CAP · CLIA · UKAS — Built for accredited labs.