Document Management
GxP document control for SOPs, STPs, specifications, MFRs and BMRs, from authoring to retirement.
- 21 CFR Part 11
- ALCOA+
- GAMP 5
ControlAuthored · Approved · Acknowledged01Author02Review03Approve04Read & Ack05Copies06Retention
Document Management
Author, review and approve controlled documents in the same system as your lab data. LimsPulse Document Management follows the pharma document lifecycle: approve, distribute for read-and-acknowledge, make effective, issue controlled copies, review periodically and retire. Every signature, stamp, copy and acknowledgement is recorded for the auditor.
Why teams choose Document Management.
Inspection-ready documents
State watermarks, signature manifests and a copy register on every controlled print.
Trained before effective
Read-and-acknowledge with e-signature builds the training record per version.
Review like on paper
Stage stamps such as TECHNICAL CHECK COMPLETED are applied automatically.
Linked to the lab
The same login, workflow engine and audit trail as your LIMS modules.
What you get
Procedure & record lifecycles
SOPs go approve → distribute → effective; records are final on approval. Set per category.
Author from templates
Versioned, approved document templates with header and footer, or upload existing files.
In-app Word editing
Edit .docx in the browser with check-out / check-in so only one person edits at a time.
Review comments
Reviewers add inline and general comments; the author resolves them before resubmitting.
Configurable approval workflow
Per-category flows with parallel groups, decisions, optional stages and runtime approvers.
E-signatures & signature stamping
Part 11 signatures with meaning, placed on the document and listed in a signature manifest.
Stage stamps
IDC, TECHNICAL CHECK or BACK CHECK stamps with user and date, applied at each stage.
Read & acknowledge
Distribute to users, roles or plants; e-signed acknowledgement per version, with overdue tracking.
Training record
Each user's acknowledged documents and versions, ready for inspection.
Controlled copies
Cover page, copy number, watermarks and signature manifest; requests, recall and reconciliation.
Status & classification watermarks
DRAFT, EFFECTIVE, SUPERSEDED, OBSOLETE and CONFIDENTIAL marks from the document's own data.
Periodic review & retention
Review due dates per category, legal hold, retire, and e-signed archive or disposal.
Classification levels
Your own ordered security levels; users only see documents they are cleared for.
Document numbering
Numbers built from category, plant and year using your number formats.
My Activities & DMS Board
Everything waiting for each person, and a board of every document by stage.
Notifications
In-app and email alerts when a document is waiting for review, approval or reading.
End-to-end workflow
- 01
Author
Create from an approved template or upload; edit in the browser with check-out.
- 02
Review
Reviewers comment and sign; stage stamps are applied automatically.
- 03
Distribute
Approved SOPs go out for e-signed read-and-acknowledge, then become effective.
- 04
Control
Issue controlled copies, run periodic reviews, supersede and retire with retention.
Questions about Document Management
The questions we hear most from labs evaluating this module.
Ready to roll out Document Management?
Tell us how your team works today — we'll show you exactly how LimsPulse fits.