Products
Automated Validation for the CSA Era.
Drowning in screenshots for your IQ/OQ? Adopt the FDA's new **CSA (Computer Software Assurance)** approach. Replace heavy documentation with unscripted testing and automated evidence capture.
Focus on Risk
Stop validating low-risk features. CSA lets you focus testing effort where it matters?봯atient safety.
Bot Workers
Let bots run your regression scripts overnight. Wake up to a green "Pass" dashboard.
Traceability Chain
We link the test result directly to the User Requirement Spec (URS), verifying intended use without the paperwork mountain.
FAQ
Q. ?뺣쭚 ?ㅽ겕由곗꺑 ??李띿뼱???섎굹??
A. Yes. FDA CSA explicitly encourages reducing non-value-added documentation. Logs replace screenshots.
Q. 湲곗〈 CSV 諛⑹떇??吏€?먰븯?섏슂?
A. Yes, we still support traditional IQ/OQ/PQ templates if you prefer.
Q. 媛먯궗愿€??CSA瑜??꾨굹??
A. FDA encourages it. For conservative auditors, we offer "Traditional Format Export."