Versioning
Keep one approved source of truth
Draft, review, approve, retire, and archive documents with clear revision history.
Document Control
Document Control
Control SOPs, forms, templates, and approvals without relying on shared drives.
Move document lifecycles into one controlled environment with versioning, review workflows, controlled print visibility, and connected training triggers. Under audit, teams show the effective SOP, prior revisions, approval signatures, and training completion tied to each release — the same evidence pattern regulators expect for GxP document control.
Key Benefits
How this module improves quality operations, reduces compliance risk, and supports inspection readiness for regulated teams.
Training
Trigger downstream competency updates
Tie revised procedures to training assignments and completion evidence.
Inspection Readiness
Answer document questions fast
Retrieve current, obsolete, and printed document evidence from one place.
Controlled document lifecycle
Auditors expect a clear path from draft to retirement — with role-based approvals, electronic traceability, and controlled distribution at every state.
01
Draft
Authors work in a controlled workspace with ownership, metadata, and change history captured from the first revision.
02
Review
Parallel or sequential review with comments resolved before approval; every reviewer action is time-stamped.
03
Approval
Electronic signatures from authorized approvers; no effective date until the approval chain is complete.
04
Effective
Only the current effective version is distributed for use; controlled copies and downloads are logged.
05
Superseded
When a new revision is effective, prior versions move to superseded status but remain readable for audit and batch release context.
06
Archive
Obsolete documents are retained per retention policy with read-only access and full audit trail for inspections.
Author and edit inside the system
Complere eQMS is not just a repository — you create, edit, and regenerate controlled documents in place, in the Microsoft Office tools your team already uses, without breaking version control or the audit trail.
MS Office Live Edit
Edit Word, Excel, and PowerPoint in desktop Office
Click Live Edit on a controlled document and it opens directly in your installed desktop Microsoft Word, Excel, or PowerPoint. When you save, the file streams straight back into the eQMS as a new controlled version — no download, re-upload, or copy-paste.
Locked & audited
Live editing stays GxP-safe
Live Edit runs on a standards-based WebDAV server with real document locking — a second user cannot edit while someone else holds the lock, and admins can force-release it. Every save becomes a controlled new version with a 21 CFR Part 11 audit entry and a stakeholder notification.
In-browser viewer
Read PDF and Office files without installing anything
Reviewers open any controlled PDF or Microsoft Office document — any prior version or attached file — in the browser, with no local application required, before they review or sign.
Template variables
Auto-fill merge fields, then regenerate
Templates carry merge-field placeholders that Complere auto-detects on upload and auto-fills with live values on generate, regenerate, or print — with a live preview. Regeneration re-applies current values without altering approval status or version history.
Version compare
See exactly what changed
Compare any two versions side by side, with field-level old-versus-new values for every change event — the difference view reviewers and auditors need without reading two documents in full.
AI-assisted review
Summarize and diff with AI — advisory only
An AI assistant can summarize a controlled document and produce a redline-style diff between versions to speed review. AI output is clearly labelled, advisory only, and never written to the controlled record — the validated audit trail stays the single source of truth.
Platform Capabilities
The specific controls, features, and workflow functions built into this module to support your quality and compliance objectives.
Lifecycle
Role-based approval routing
Configure review and approval pathways by document type, site, or function.
Control
Controlled prints and download logging
Show which copies were issued, when, and under which status.
Search
Structured metadata and folder governance
Use default fields, ownership, and taxonomy to simplify retrieval.
Traceability
Link documents to CAPA, training, and change
Keep impact analysis visible across the quality system.
Frequently asked questions
Document editing, collaboration, and Part 11 control in Complere eQMS.
Can I edit Microsoft Word, Excel, and PowerPoint files in Complere eQMS?
Yes. Complere eQMS includes Live Edit — click Live Edit on a controlled document and it opens directly in your installed desktop Microsoft Word, Excel, or PowerPoint application. When you save, the file streams straight back into the eQMS as a new controlled version, with no download, re-upload, or copy-paste.
Does live editing keep documents under GxP and 21 CFR Part 11 control?
Yes. Every saved live edit is captured as a controlled new version with a 21 CFR Part 11 audit-trail entry and a stakeholder notification. Live editing runs on a standards-based WebDAV server with real document locking, so a second user cannot acquire an edit lock while someone else is editing, and administrators can force-release a stuck lock.
Can reviewers read documents without installing software?
Yes. An in-browser viewer renders controlled PDF and Microsoft Office documents — any prior version or attached file — directly in the browser, with no local application required.
Does Complere support document templates with auto-filled fields?
Yes. Templates can contain merge-field placeholders that Complere auto-detects when a Word file is uploaded and auto-fills with live values when a document is generated, regenerated, or printed, with a live preview before you commit.
Can I compare versions of a controlled document?
Yes. Complere shows a clear before-and-after difference between document versions, including field-level old-versus-new values for every change event, so reviewers and auditors can see exactly what changed.
See how controlled document workflows can anchor the full QMS
Use document control as the starting module for digital rollout, then expand into CAPA, audits, change, and training.