Document Management Hub
A deep dive into the Document Management Hub — create controlled documents, link them across modules, route them through review and approval, sign with 21 CFR Part 11 e-signatures, and archive records for the long term, all inside MoniDoseQMS.
The Document Management Hub is where your day-to-day quality work lives — document control, the document library, SOP and ISO templates, e-signatures, and the approval workflow. Everything stays inside the QMS, so you stop juggling external tools.
What you'll learn
- 1
Open the Document Management Hub
One hub for document control, the document library, SOP & ISO templates, the signature workflow, and e-signatures.
- 2
Create a controlled document
Auto-generated document ID, title, category, version, status, classification, training links, regulatory references, and reviewer/approver assignments — all on one form.
- 3
Link documents across modules
Connect a document to products, assets, change control, suppliers, CAPA, or any QMS record so traceability is built in from the start.
- 4
Upload files or pick from the template library
Add documents from your computer or browse hundreds of pre-built SOP and ISO templates so you never start from scratch.
- 5
Browse, preview, and edit in the document library
Search the library, preview any file, edit metadata, and edit documents in place — every change is auto-saved and attributed to who made it.
- 6
Integrity verification
Every uploaded file is hashed for FDA 21 CFR Part 11. Any modification is detected and logged automatically.
- 7
Sign documents inside the platform
Draw your own signature once and reuse it. Sign any document with your role and password — no external e-sign tools needed.
- 8
Configure the signature workflow
Choose 1-, 2-, or 3-step author / reviewer / approver flows, set role-based access, and enable or bypass dual control. Every change is locked in the audit trail.
- 9
Approve and release
Apply your e-signature and the document moves Pending → Authored → Approved, with regulatory compliance badges (FDA 21 CFR Part 11, ISO 13485, EU MDR) updated automatically.
- 10
Approved records archive
A central, immutable view of every approved record across the QMS — searchable and audit-ready.
- 11
Long-term archival with multi-market retention
Assign retention periods aligned to MDR, FDA, UK MDR, and Japan rules — 10, 15, 20, or 25 years — for multi-market compliance.
Why it matters
A QMS only adds value if it speeds your team up. MoniDoseQMS exists to do exactly that — every step here is designed to make controlled documents, signatures, and approvals faster and simpler, not heavier.