Active execution, not passive records.
LuminLogic Documents goes beyond storing records. Author, review, approve, and release SOPs and work instructions under a configurable workflow with 21 CFR Part 11 signatures and automatic retraining, connected natively to CAPAs, change requests, and the audit trail.
Controlled documents, without the bottleneck. Without the spreadsheets.
Every record inherits the same workflow engine, 21 CFR Part 11 signatures, and audit trail as every other content type in LuminLogic. Linkage across modules is native, not a stitched-together export.
Controlled authoring
Draft in the platform or import from Word, with redlines preserved, sections tracked, and revisions tied to the workflow stage.
21 CFR Part 11 signatures
Author, QA, Medical Affairs, Release: bound cryptographically to the revision, with meaning and intent captured at the moment of signing.
Auto-retrain on release
Release a revision; assignees impacted by the change are retrained automatically, with completion records signed and archived.
Native cross-links
Linked from CAPAs, change requests, training, and DDF records. Trace impact in either direction, not via a stale export.
Discoverable, not buried
Full-text search across every revision, with effective-date snapshots so an auditor sees exactly what was in force on any given day.
LuminLogic IQ embedded
Summarize a folder, draft a revision summary, gap-analyze against 21 CFR Part 820, every IQ touch logged to the record’s audit trail.
Documents, end to end.
Out-of-the-box workflow ships ready for ISO 13485 and 21 CFR Part 820, and admins can tune it without a services engagement.
Draft
Author in-platform with templates, or import a Word draft. Sections route to subject-matter experts for parallel review.
Review
QA and medical-affairs reviewers comment, redline, and require resolution before progressing to approval.
Approve
Configurable approver sets: sequential or parallel, sign under 21 CFR Part 11 with intent captured at signing.
Release & retrain
The revision goes effective on a chosen date; impacted assignees are retrained automatically and signed off.
Every document carries its own proof.
Versioning, review, QA and medical-affairs approval, 21 CFR Part 11 signatures, and a complete audit trail travel with the record, not in a separate spreadsheet.
Approved and draft revisions coexist safely.
Routed, gated, and locked on approval.
Every controlled document, one source of truth.
Drafts, reviews, approvals, and effective revisions, with periodic-review clocks, and LuminLogic IQ flagging downstream impact the moment a document changes.
Documents lives on the same platform as everything else.
CAPA
Investigations & effectiveness. Every CAPA links back to the controlling SOP.
Learn moreChange Control
Triggered by a document change request. Impact assessment routes to the right reviewers.
Learn moreTraining
Role-based retraining on release, with 21 CFR Part 11 completion records archived.
Learn moreComplaints
A complaint surfaces a procedural gap, link the SOP and route a revision in one step.
Learn moreStop chasing the latest revision.
See how LuminLogic Documents replaces the SharePoint-plus-spreadsheet status quo, with retraining and audit trail built in.