Released revision D to point of use.
Quality approved · effective since 02 Jul 2026
Document Management System
One current version.Everywhere you look.
Document Control, Change Control, and Training on one governed record, from draft to obsolete.
One controlled record across regulated operations
- Medical Devices
- Pharmaceuticals
- Cosmetics
- Food Processing
- Aerospace
- Automotive
You have the document. Nobody can find it when it matters.
Every audit, change and retraining starts with a hunt across drives, folders and inboxes.
- Evidence assembly
Days to assemble one audit record
Days of team time to assemble evidence, per audit.Evidence already bound. All evidence captured and attached in one place.
How they handled it · 0:48Applechem - Version control
Three versions of one SOP
3 copies claiming to be current.One effective version. Always one source of truth.
How they handled it · 0:47Mikala Hukka - Change effectivity
The floor hears about the change last
Months from approval to the floor.Effectivity reaches the line. Automatically notified. Effective everywhere.
How they handled it · 2:11Harmonic Bionics - Training cascade
Retraining lands weeks after the change
Weeks untrained on the effective version.Training assigned on release. Automatically assigned. Automatically tracked.
How they handled it · 2:20Jarod Markley
Three modules. One continuous record.
The change, the controlled revision, and the training obligation stay connected from the first decision to the final signature.
Document Control
One true copy.
Author, review, approve, distribute, and periodically review controlled documents with full version history.
- Controlled templates and numbering
- Review and approval routing
- Watermarked, distributed renders
- Periodic review with an owner
ISO 900121 CFR Part 11ISO 1348521 CFR Part 820
Change Control
Every revision carries its evidence.
Change orders and revisions routed through configurable approvals, with impact assessment on the record.
- Change orders with impact assessment
- Configurable approval matrices
- Evidence attached to the revision
- Cascades into training on release
ISO 900121 CFR Part 820ISO 13485
Training Management
The change reaches the people.
A revision cascades into the training obligation, so people are always current on the version they use.
- Role-to-document training matrix
- Auto-assignment on new revisions
- AI-generated quizzes from the SOP
- Completion reporting for audits
ISO 900121 CFR Part 820ISO 13485
The controls a regulated library runs on.
Version history
Every revision retained under the edition it shipped.
Periodic review
Review dates that route to an owner and expect an attestation.
State watermarking
DRAFT, EFFECTIVE, OBSOLETE stamped on the render.
Part 11 e-signature
Signer, meaning, and timestamp where the record requires it.
Where-used lookup
Reverse-trace a document to everything that references it.
Scoped auditor access
Read-only, watermarked, without handing over the library.
Every state has a gate. Every gate has an owner.
Follow the work through the lifecycle.
Works with the systems you already run.
Connect document control to the tools already holding your product, people, and process data.
- SharePoint
- SAP
- Oracle NetSuite
- Solidworks
- Slack
- SSO/SAML
For the teams that keep every document current.
From first draft to audit evidence, every role works from the same current record.
Document Controller
OwnsDraftEffective
- Issue revisions, chase approvers
- Pull document trees for audits
- Close out periodic reviews
Training Coordinator
OwnsEffectiveTrained
- Assign training from new revisions
- Chase incomplete training
- Report completion for audits
OwnsApprovalRelease
- Approve changes of consequence
- Own the audit programme
- Chair management review
Results, honestly stated, from quality teams like yours.
Short, candid accounts of document control, training, and change management from the people doing the work.
Biovation LabsJesse Kolstad, Director of QualityNew starters see their SOP training on day one
ApplechemWilson LinApprovals that ran up to 8 months now take about two weeks
Biovation LabsJesse Kolstad, Director of QualityEach revision carries the data forward, with who and when
Carol WilsonConstructionAudit certs filed to the PO, not dug out over six weeks
Harmonic BionicsClarissa ArcherEvery change records the reason the FDA requires
Natalie JonesNutritional SupplementsWithout it, re-approvals go back to email and phone calls
One lifecycle. Every standard.
Control the record once, then prove it against whatever governs your operation.
- ISOISO · Global
ISO 9001
Quality management system requirements.
- FDAFDA · US
21 CFR Part 11
Trustworthy electronic records and signatures.
- ISOISO · Global
ISO 13485
QMS for medical devices.
- FDAFDA · US
21 CFR Part 820
Quality System Regulation for device cGMP.
- European CommissionEC · EU
EU GMP
GMP for medicinal products.
- WHOWHO · Global
GMP
Consistent, controlled production.
Validated across
- Medical Devices
- Pharmaceuticals
- Cosmetics
- Food Processing
- Aerospace
- Automotive
The questions procurement and QA ask first.
Anything else, bring it to the walkthrough.
Three modules on one record: Document Control, Change Control, and Training Management. A change order drives the revision, and the revision drives the training assignment, without re-entry between tools.
Bring the SOP you could not find the current version of.
We will run it through the lifecycle live, from draft to Part 11 approval.