SOPs your FDA auditor will approve and your operators will actually use

In pharmaceutical manufacturing, documentation isn’t optional — it’s the product of your quality system. FDA 21 CFR Part 211, EU GMP Annex 11, and ISO 13485 all require current, controlled, and accessible work instructions. But traditional SOP creation is so painful that documentation often lags reality — creating exactly the compliance risk you’re trying to avoid.

StepFlow was designed to eliminate the gap between how work is actually done and how it’s documented. Start with a video of the actual procedure. The AI generates a draft SOP with numbered steps, clear action language, and critical point callouts. Your SME reviews, edits, and approves. Done — in a fraction of the time.

Built for quality systems

Every StepFlow document carries full version history, timestamps, and an immutable audit trail. When an investigator asks to see version 1.3 of your tablet coating procedure from 18 months ago, you pull it up in seconds — not hours of searching through file servers.

Change control that doesn’t bottleneck operations

Process improvements shouldn’t be blocked by documentation backlogs. StepFlow’s change flow lets you record the updated procedure, generate a redlined comparison against the previous version, route for review, and publish — all in a fraction of the time of traditional change control.

Eliminating the procedure-reality gap

483 observations frequently cite SOPs that “don’t reflect current practice.” With StepFlow, the documentation starts from the actual practice — not from memory, not from what the QA department thinks should happen. The result is procedures that operators trust because they’re accurate.