One current version.
Never a stale SOP on the floor.
"Operator was using an outdated SOP" is one of the most common — and most preventable — GMP inspection findings. ValiCore locks every document to a single current version and routes revisions through e-signature approval before they go live.
What is document control in pharma?
Document control is the system that governs how SOPs, work instructions, specifications, and forms are drafted, reviewed, approved, distributed, and revised — ensuring that only the current, approved version is ever in active use, and that every past version is retrievable but clearly superseded. It's distinct from generic "document management" (which just stores files): document control enforces workflow — a document can't go live without approval, and once superseded, it can't be mistaken for current.
Built for
What goes wrong without it
Outdated SOPs used on the floor
Without version control, operators keep working from a printed or saved copy of an SOP long after it's been revised — one of the most frequently cited, and most preventable, audit findings.
Approval workflow lives in email
"Reply-all to approve" isn't an e-signature and doesn't produce an auditable, attributable approval record — it produces an email thread an inspector will ask you to explain.
Training doesn't follow the revision
When an SOP changes, every affected employee needs to be re-trained on the new version — a step that's easy to forget without an automatic trigger tying training to document revision.
What ValiCore actually does here
Single current-version lock
Only one version of any document is ever "active" — superseded versions are automatically retired from use but remain retrievable for audit history.
21 CFR 211.180E-signature approval workflow
Draft → Review → Approved, each gate requiring an individual e-signature with a captured meaning — not an email approval chain.
21 CFR Part 11Automatic training assignment on revision
When a document is revised, affected staff are automatically flagged for re-training on the new version.
Scheduled periodic review
Every document carries a review-due date, so SOPs don't silently age past their intended review cycle.
Full revision history, always retrievable
Every past version, its approval record, and the reason for revision stay in the audit trail — nothing is deleted, only superseded.
Regulations this addresses
Related modules
Frequently asked questions
Document management is largely about storage and retrieval — a shared drive with folders is technically document management. Document control adds enforced workflow: version locking so only one version is ever active, mandatory approval gates before a document goes live, and automatic retirement of superseded versions. A GMP inspector checks for document control, not just document storage.
It should — this is one of the most valuable connections in a quality system. When a document is revised, the affected roles or individuals should be automatically flagged for re-training on the updated version, closing the loop between "the SOP changed" and "everyone actually knows it changed."
Under 21 CFR Part 11, if the approval record is maintained electronically, it needs an electronic signature meeting Part 11's requirements — unique to the individual, non-reusable, with a captured meaning (e.g. "Approved") and timestamp. An email saying "looks good, approved" doesn't meet this bar.
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