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. Full audit trails.

Reviewed by Gregor Obreza , Co-founder and CEO

Try SOPX free Book a 15-min demo

10min

from video to SOP draft

Built-in

approval workflows (coming soon)

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Tracking which version of each SOP is current — and ensuring no one follows an outdated procedure — is a constant compliance risk.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

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.

Built-in approval workflows (coming soon)

Route SOPs through approval before publishing. Designated reviewers sign off on every version. Every approval is recorded with timestamps.

Complete version history

Full version history with labels, timestamps, and change tracking. Previous versions are preserved and accessible. Audit-ready at all times.

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

Quality & Compliance

Generate the procedure from a process video. Save a new version every time it changes. Translate it to 50+ languages with a side-by-side review editor. Share it at the workstation by QR code. Export to PDF or Word for an audit binder.

Learn more →

Process Standardization

Process variation drives quality issues, waste, and errors. Standardize every task with visual SOPs generated from your best methods, accessible at every workstation.

Learn more →

Knowledge Retention

Every resignation takes undocumented process knowledge with it. Capture expertise in structured SOPs before turnover leaves you scrambling.

Learn more →

Work Instructions

Generate visual, step-by-step work instructions from process videos in minutes. Accessible on any device, in any language. No more unread manuals.

Learn more →

Frequently Asked Questions

Does SOPX meet GMP documentation requirements?

SOPX provides the documentation infrastructure for GMP compliance — versioned, approved SOPs with full audit trails. You create the content with AI assistance, maintain it with built-in version control, and demonstrate compliance with complete change history.

How does the approval workflow work?

When an SOP is ready for review, route it through your approval workflow. Designated reviewers evaluate and approve before the new version is published. Every approval is recorded with timestamps for audit traceability.

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 — they 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 as a draft, submit for approval, and publish when approved. The full history — what changed, when, and the version label — is preserved permanently.

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.

See SOPX pricing → How SOPX works →

Start building your GMP-ready SOP library

Try SOPX free Book a 15-min demo