The Traditional Burden of CSV in Medical Devices
Paper-heavy validation. Documentation overloads your team and repetitive revalidation consumes valuable time.
Reactive Change Control. Every system update triggers redundant testing and approval cycles, costing more time and money.
Fragmented traceability. Disconnected systems obscure visibility and delay investigations.
Compliance at the cost of innovation. Slow, manual CSV processes extend time–to-market for critical devices.
Traditional CSV Can’t Keep Up
Traditional validation treats every system as high risk, regardless of its actual impact on product quality. The FDA’s Computer Software Assurance (CSA) guidance addresses this by replacing documentation-heavy processes with risk-based assurance focused on intended use and patient safety.
ValGenesis VLS is the first AI-enabled, single platform built to digitalize how medical device and MedTech manufacturers execute CSV and CSA.
Whether validating enterprise platforms, QMS software, or production systems governed by the FDA’s Computer Software Assurance for Production and Quality System Software guidance, ValGenesis delivers a compliant, scalable, and digital-first approach aligned with FDA software validation requirements and ISO 13485.
Advancing CSA with ValGenesis
ValGenesis Validation Lifecycle Suite transforms CSA for Medical Devices:
- 50% Faster Validation Cycles.
Shift from scripted testing for every system to risk-based assurance aligned with intended use and software impact. Automate protocol creation and execution within a compliant framework (FDA CSA guidance, ISO 13485, GAMP 5). - 30% Reduction in Validation Costs.
Eliminate manual rework and redundant testing through automation and reusability. Leverage vendor test evidence, digital traceability, and centralized validation assets to scale assurance across systems without adding headcount or compromising compliance. - 90% Less Audit Prep Time.
Every validation activity is digital, time-stamped, and version-controlled—ready for FDA or Notified Body inspections at any moment.
ValGenesis enables medical device and MedTech manufacturers to adopt risk-based validation and software assurance for medical devices, maintaining full compliance with FDA requirements for software validation, ISO 13485, and 21 CFR 820.
Empowering Life Sciences
We chose ValGenesis because they were a known and trusted vendor. We had limited time and resources, and we knew the quicker we could implement the solution, the sooner we’d start realizing value from it.
Joshua Pelina
Validation Engineer
Working with ValGenesis was great. They helped us align the system with our new CSV program and uncover opportunities for process improvements and efficiency gains to maximize value.
Jeff Onis
Global IT Data Integrity Manager
Our ERP upgrade would touch every department in the company. This was the ideal opportunity to transition from paper-based to digital validation, and now we’re reaping the benefits: signoff documents organized in one place, simplified review and approval, no more issues deciphering handwriting, one-click access to deviation reports, reduced printing costs—all totaling up to a successful outcome.
Mabel Santana
Compliance Manage
ValGenesis provides an exceptionally detailed level of configuration for user roles, which we found to be incredibly powerful and effective.
Laurie Lipper
IT Computer System Validation Manager
Legibility concerns were a common problem when delivering hard-copy qualifications that were documented using pen and paper. And simple, common mistakes like accidentally writing 2024 instead of 2025 after the year change are a big deal in a regulated industry. With ValGenesis, date attributions will always be correct, and legibility problems are solved.
Jonathan Revere
Director of Validation
We used ValGenesis’ vendor testing documentation because it was thorough, and it saved us a lot of time. We estimate saving 100 hours of work, which we reallocated to other parts of the project like training.
Raghav Mathur
Senior Validation EngineerWhat's in the Suite
iVal
Supercharge validation with ValGenesis iVal™. AI-powered authoring, automated execution, live anomaly flags, and bulletproof traceability slash cycles by up to 80% and cut observations by 90%. From CQV to CSA, you’ll be audit-ready and market-ready faster than ever. iVal takes digital validation to the next level.
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iClean
Halve cleaning validation timelines and wipe out manual math with ValGenesis iClean™. Automated MACO calculations, ADE-aligned limits, 2D/3D equipment maps, and rule-driven workflows deliver digital, inspection-ready files across all sites. Standardize globally, flex locally, and gain real-time oversight - discover iClean today.
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iOps
Leave paper logbooks behind with ValGenesis iOps™. Mobile, QR-enabled forms capture every use, cleaning, and calibration event in real time; automated reviews, deviations, and alerts seal compliance gaps. Achieve 100% traceability, trim documentation labor by 70%, and connect ops to quality with iOps today.
Learn MoreWhy Test More When You Can Test Smart?
Transition from CSV to CSA with confidence. Schedule a 15-minute demo to learn how digital validation cuts cycle times, reduces costs, and improves audit readiness.
Book a Demo