Security & Validation
How RegulArk handles your documents, and how your team validates it for regulated use.
How Your Data Is Handled
Three things that are true of every RegulArk installation.
No patient data
RegulArk works from FDA labeling documents and your company details. It never handles patient records or payment information.
Nothing applied unattended
The software never writes regulatory wording on its own. Every proposed change is accepted or rejected by a person on your team.
A record you can check yourself
Every change and every decision is written to a tamper-evident record: once written, it cannot be altered or deleted without that showing. Each output comes with a small tool that rechecks the record on your own machine, without us.
What we don't claim yet
We do not yet hold a SOC 2 report; it is planned. An independent security test is planned. We will say “21 CFR Part 11 compliant” only after a formal assessment.
Validation
RegulArk drafts; your reviewer decides. Any software used in a regulated process must be shown to work as intended. We supply the evidence that makes this quick.
What RegulArk does
A clear statement of what the software is meant to do, and what it leaves to your team.
The controls on every change
How each change is reviewed, decided and recorded, so nothing is applied without a person's decision.
Tests you can rerun
Test cases and results you can run again on your own installation and sign off as your own.
Every change on record names the exact software version behind it, so what you tested is what ran.
Validation package: in preparation.
Questions From Your QA or IT Team?
Send them over. We answer in writing, so the reply can go straight into your vendor file.