What's the difference between an SOP and a quality procedure here?

Both are authored, approved, and versioned the same way. An SOP is the operational instruction your team runs; a quality procedure governs the system around it — CAPA, change control, training. In ForgeSOP they're the same kind of connected record, so they cross-reference instead of living in separate tools.

How do e-signed approvals work?

An approver re-authenticates, states a reason, and signs. The signature is bound to the exact bytes of that revision and to their role, so a complete 21 CFR Part 11-shaped record — who signed, what, and why — travels with the version forever.

How do I prove which SOP version was in effect on a given date?

Every revision is timestamped and immutable. Open any date and ForgeSOP shows the exact version that was live, who approved it, and which operators acknowledged it — no reconstructing from email.

What is the quality loop?

A deviation is logged against the version in effect, routed to root cause, and resolved through a CAPA. The corrective action doesn't stop at a ticket — it forces a new signed SOP revision, so the fix becomes the procedure.

Does an exported SOP verify on an auditor's machine?

Yes. Each export carries a chain-proof hash of its revision. An auditor can verify it offline against the record — no access to ForgeSOP required — and confirm nothing changed after signing.

SOP & Quality — Author, approve, prove

Create, manage, and prove every SOP and quality procedure.

Block-based authoring with AI-assisted drafting, e-signed approvals, immutable version history, and controlled distribution — with a quality loop that turns every deviation into an improved procedure.

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Built for ISO 9001 · 21 CFR Part 11 · EU GMP Annex 11 · ISO 13485

app.forgesop.com/sop/204/publish

Publish revision

SOP-204 — Aseptic gowning

v4 · DRAFT

Effective

On approval

Supersedes

v3 · live 412 days

Author

A. Reyes · Mfg

Approver

QA — required

Separation of duties

An author can't approve their own SOP. A second approver with QA authority must e-sign.

chain proof · 9f3a…c1b2 · hash-stamped on sign

Chain proof · verified

Audit-grade by default

Chain proof

Every revision is hash-stamped and immutable. Verify any export offline — no black box.

E-signatures

21 CFR Part 11-shaped e-signing with re-authentication and a recorded reason for every action.

Regulatory reports

ISO 13485, EU GMP Annex 11, and 21 CFR 820 evidence exported on demand.

One connected record

An SOP is a version, not a file. Author, approval, and deviation hang off one record.

01— The problem

An SOP in four "final" files is an SOP nobody can prove they followed.

Word docs in SharePoint, an approval buried in an email thread, and a deviation that never makes it back into the procedure.

The SOP lives in a Word doc

Procedures sit in SharePoint folders, Confluence spaces, and email attachments. Four files named "final," and nobody can say which one the floor is actually reading.

Nobody knows the current version

An approval is a moment in a thread; a revision is a filename; "who signed it?" is a mystery. When the auditor asks what was in effect last March, the search starts from zero.

The fix never reaches the procedure

A deviation gets logged, a CAPA gets approved somewhere else, and the corrective action never lands back in the SOP. The same gap reopens next quarter.

02— The platform

One place to author, approve, and run your procedures.

Everything you need to turn SOP & Quality on — drafting, sign-off, distribution, and the loop that keeps procedures improving.

Block-based SOP editor

Headings, lists, callouts, images, tables, and embedded checklists — structure that reads on the floor, not free-text Word docs.

AI-assisted drafting

Draft a first pass from an existing document or protocol, then edit and own it. Nothing publishes without an e-signature.

E-signed approvals

Approvers re-authenticate and sign. Each approval mints a new immutable revision, with separation of duties enforced by role.

Version history & diffs

See any two versions side-by-side without losing the trail, and prove which version was in effect on any date.

Controlled distribution

Gate distribution at training or review steps. Operators always run the current version, and read-acknowledgments are e-signed.

The quality loop

Deviations route to root cause through CAPA. The fix forces a new SOP revision — reconnecting every loose end.

03— The loop

Draft. Approve. Run. Improve.

Draft

Author in the block editor, with AI suggesting a first pass from your existing docs.

Approve

A re-authenticated e-signature binds the exact bytes into a new immutable version.

Run

Publication gates govern training and review. Teams always work from the version in effect.

Improve

Deviations open CAPAs; the fix loops back into the next signed version of the procedure.

The bridge

Not a document store. The same connected record.

An SOP isn't a file — it's a record. Author, approval, deviation, and fix all hang off one version. When something changes, it routes through CAPA and re-emerges as the next signed version. One connected record, never re-keyed.

Connected library. Every SOP and quality procedure, one source of truth.

100%

Of approvals e-signed and bound to an immutable, timestamped revision.

Stale versions in circulation. Operators only see the version in effect.

1:1

Every deviation maps to a CAPA and a new signed version. No orphan fixes.

What this satisfies

ISO 900121 CFR Part 11EU GMP Annex 11ISO 13485

ForgeSOP provides the records and controls — version history, e-signatures, audit trail — that support these frameworks. See Trust & Security for the current certification state.

"We replaced three SharePoint folders, a Confluence space, and an email thread with one place. Audits stopped being a fire drill."

Quality Lead

Pharma manufacturer, 6 sites

CAPA

Open corrective actions straight from a deviation.

Audits & inspections

Pull the version in effect with one click.

Compliance management

Map records to the framework you report against.

Audit trail

Every signature, view, and change, timestamped.