GMP-Ready SOPs, Created and Maintained with AI

Film procedures or import existing GMP documentation as PDFs. AI creates structured, versioned SOPs. Organize by process area. Control access for regulatory compliance. Built-in version history.

Gregor Obreza Reviewed by Gregor Obreza , Co-founder and CEO
10min

from video to SOP draft

Built-in

approval workflows

100%

version traceability

The Challenges

GMP documentation is time-consuming

Creating and maintaining compliant SOPs across dozens of procedures is a significant time investment. Documentation backlogs delay production and risk audit findings.

Regulatory changes require rapid SOP updates

When GMP requirements evolve, every affected SOP must be updated, approved, and deployed quickly. Paper-based systems create dangerous delays.

Version control across multiple documents is error-prone

Tracking which version of each SOP is current, and ensuring no one follows an outdated procedure, is a constant compliance risk.

How SOPX Solves This

1

AI-generated SOPs with GMP structure

Film your procedures and let AI generate structured SOPs. Add GMP-specific details, warnings, and specifications. Review, approve, and publish.

2

Built-in approval workflows

Route SOPs through approval before publishing. Designated reviewers sign off on every version, and an optional four-eyes rule blocks self-approval. Every action is recorded in a read-only procedure history with names and timestamps.

3

Complete version history

Full version history with labels, timestamps, and change tracking. Previous versions are preserved and accessible.

How SOPX compares

Teams evaluating SOPX for pharmaceuticals teams usually weigh it against Dozuki , SwipeGuide , and VKS . The side-by-side breakdowns show where each tool fits and where SOPX pulls ahead.

Relevant Use Cases

Built for These Roles

Frequently Asked Questions

Does SOPX meet GMP documentation requirements?
SOPX provides the documentation infrastructure for GMP compliance: structured, versioned SOPs with complete change history. You create the content with AI assistance and maintain it with built-in version control, approval sign-off before publishing, and a read-only procedure history that records what changed, who changed it, and when.
Does SOPX support approval workflows?
Yes. Turn on approvals and nothing publishes until a designated reviewer signs off: draft, submit for review, then approve and publish or request changes with a reason. An optional four-eyes rule blocks self-approval, and a read-only procedure history keeps every version and records who did what and when. Approvals are available on Pro and Enterprise and are off by default, so smaller teams can keep the simple review-and-publish flow.
Can we export SOPs for regulatory submissions?
Yes. Export SOPs to PDF or Word for regulatory submissions and audits. Share SOPs via public link with auditors or external reviewers, who view the full procedure without creating an account. API access is available for integrating SOP data into your existing quality management system.
How does SOPX handle change control?
Every SOP maintains a complete version history. When a change is needed, create a new version from the current one, edit it as a draft, route it through approval, then publish once a reviewer signs off. The full history (what changed, who changed it, when, and the version label) is preserved permanently in a read-only procedure history.
How do I convert paper GMP SOPs into a controlled digital library?
Upload your existing GMP PDFs and AI parses each into a structured digital SOP with steps and images extracted automatically. Organize them into workspaces by process area, set who can edit, and let version history track every change from there. New revisions are routed through approval, signed off, and published, with prior versions preserved. SOPX is the fastest way to move a binder-based library into version-controlled digital SOPs.
What size pharmaceutical operations does SOPX serve?
SOPX is built for pharmaceutical operations teams of 20-250 people, companies that need compliant documentation without the overhead and implementation timeline of enterprise platforms. Start with a free trial; no implementation project required.

Explore SOPX

Pricing is public. The product page covers how it works end to end.

Start building your GMP-ready SOP library