Pharmaceutical SOPs, Drafted and Maintained with AI

No. SOPX is not a validated system. It does not offer 21 CFR Part 11 electronic signatures, and its procedure history is not a full audit trail. What it gives you is structured, versioned SOPs, approval sign-off before publishing, and a read-only procedure history of what changed, who changed it, and when. Teams use it to draft, maintain, and train on SOPs. Check with your QA team whether that fits your validation requirements.

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 included on every plan and are off by default, so smaller teams can keep a simple review-and-publish flow. On Premium and Enterprise, multi-step approval chains send a version through ordered stages such as Technical review, QA, and HSE, with one or more approvers per stage. The last approval publishes the version.

Yes. Export SOPs to PDF or Word for audits and your document files. Public links let anyone with the link read a procedure, so keep them for SOPs that are not confidential. SOPX has no public API. Custom integrations with a quality management system are an Enterprise add-on, scoped and billed separately.

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 kept in a read-only procedure history.

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.

SOPX fits pharmaceutical operations teams of roughly 20 to 300 people that want structured, versioned SOPs and training records without a long implementation project. Start with a free trial. If you need a validated eQMS with Part 11 electronic signatures, SOPX is not that system.