PlatformDocument control

Document control software for GxP, signed at every step

Everyone works from the current version, and every version has the right signatures behind it. QMSdesk™ document control software takes each SOP from draft to effective with signed authoring, review and approval, and assigns the training before the new version takes effect.

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Document control

SOP-014

Cleaning of filling line 2, version 3

Approved, pending effective date

Workflow

Step 4 of 6: Approved

Approvers: 2 independent, both signed
Effective date: 14 days after approval
Training: Assigned to 12 people

Training assigned

Everyone affected is trained before version 3 takes effect

The current version, always, and the proof of how it got there

The right version at the point of use

While a new version waits for its effective date, the current one stays in force. The new one is marked "Approved — pending effective date" and takes effect on its date, automatically.

Reviews that mean something

An author never reviews or approves their own document. High-criticality documents need two independent approvers. Every signature records what it means, so a review is never mistaken for an approval.

Training that's ready when the SOP is

Training is assigned the moment a document is approved. Your people have the grace period, 14 days by default, to train before the new version takes effect.

How QMSdesk document control software works

Every controlled SOP, work instruction and policy follows the same signed path, which is what SOP management software should do.

Step 1 of 6
Draft
Write in the editor or upload a file. The author signs on submission, attesting the draft is complete.
Step 2 of 6
Review
Every assigned reviewer signs. A reviewer can request changes, recorded as an attributed comment, or reject with a signed finding. Either way the document returns to draft for a full re-review.
Step 3 of 6
Approval
Every assigned approver signs. High-criticality documents need two, independent of each other and of the author.
Step 4 of 6
Approved
The grace period starts and training is assigned. An early release is possible, with a signed justification from someone other than the author.
Step 5 of 6
Effective
The document takes effect on its scheduled date, and it's superseded when the next version takes over.
Step 6 of 6
Withdrawn
Obsolete or retired, by the quality unit, never deleted.

GMP document management with nothing left to trust

Controlled copies you can account for

Download an effective document and QMSdesk renders a controlled copy: a PDF with a "CONTROLLED COPY" banner, its signature log and a unique request ID. Every download is written to the audit trail. If the log can't be written, the download doesn't happen.

External documents, labeled for what they are

Standards, guidance, CVs and quality agreements are published in one step as reference documents, with their issuing body, version and issue date, and currency checks. Every copy carries "REFERENCE DOCUMENT — NOT INTERNALLY APPROVED". A licensed standard can be read in the app with download switched off.

Bring your history in honestly

Import your existing SOPs under one signed migration attestation per batch. Each document carries a permanent "Migrated" badge, and QMSdesk never records an approval that happened outside the system.

Reviews that don't slip quietly

Periodic review tasks are raised on schedule. If a review runs more than 30 days late, a risk opens in the register, so a stale procedure becomes a visible risk before it becomes a finding.

Feature index

Everything in document control

Lifecycle and signatures

Controlled lifecycle: Draft, then Review, then Approval, then Approved, then Effective, then Superseded, Obsolete or Retired
Signed authoring, review and approval, each with a recorded signature meaning
Request changes (attributed comment) or reject (signed finding), with every return going back to draft
Author, reviewer and approver kept separate, enforced when each signature is applied
Two independent approvers for high-criticality documents
Effective-date grace period, 14 days by default, with signed early release
Obsolete and retire decisions held by the quality unit, never the Administrator

Distribution and access

Controlled-copy PDF with banner, signature log, request ID and your logo on the cover page
Every download logged, and blocked if logging fails
Restricted documents, hidden from lists, search, counts and exports for anyone without access
View-only licensed standards
Global search that respects permissions and site

Content and links

Write in the editor or upload a source file
Typed cross-references, a "Referenced by" view and stale-reference flags

Review, training and risk

Training assigned on approval
Periodic review tasks, with a risk opened after 30 days overdue

Reference documents and migration

Reference documents with provenance, currency checks and a "not internally approved" banner
Migration import with a signed batch attestation and a permanent "Migrated" badge

Records

Configurable numbering, never reissued
Soft archive only, never hard deletion, with retention floors of 7, 10, 15 or 30 years by regulatory profile
Recorded in the SHA-256 hash-chained audit trail

One connected system

Connected across QMSdesk

Approval assigns the training automatically in training management.

A CAPA plan that needs a document change raises its change control at plan approval.

Overdue reviews open risks in risk management.

Migration and go-live run through implementation.

Regulations

Regulations it's designed to support

QMSdesk document control is designed to support the document and record controls in:

21 CFR Part 11 §11.10, through signed, attributable, audit-trailed records
EU GMP, including Annex 11
ISO 9001 §7.5. QMSdesk is also built to support organizations working to ISO 13485:2016, including §4.2.4
ICH Q10 §3, and ALCOA+ principles

Questions buyers ask

Can a reviewer or approver be bypassed?

No. A document moves forward only when every assigned reviewer, and then every assigned approver, has signed. No one can override the remaining approvers, and the Administrator holds no approval authority.

Does incomplete training hold up the effective date?

No. The document takes effect on its scheduled date. Overdue training is escalated in training management, and when the overdue training belongs to a GxP-critical role, a risk opens.

Can we bring our existing SOPs?

Yes. Each import batch is signed under one migration attestation, and every migrated document keeps a permanent "Migrated" badge. Nothing is presented as approved inside QMSdesk unless it was.

How do we control external standards we don't approve?

As reference documents. They're published in one step with their provenance and currency checks, and every copy is labeled "not internally approved". Licensed standards can be viewed without being downloaded.

What does a controlled copy look like?

A PDF with a "CONTROLLED COPY" banner, the document's signature log and a unique request ID, with the download recorded in the audit trail.

The current version, always, with the proof behind it

Bring a document-control bottleneck you're living with today, and we'll run it through QMSdesk with you.