Wardian — Continuous validation infrastructure for life sciences IT
Wardian is continuous validation infrastructure for life sciences IT and Quality teams. It keeps a living model of every validated GxP system you run and continuously matches your requirements against every vendor release, configuration change, and in-house feature addition as it lands, with full reasoning, citations, and a human-in-the-loop reviewer workflow — replacing 200–500+ hours a year of manual upgrade documentation per company.
Built for 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q10, and FDA Computer Software Assurance (CSA) environments. Deep day-one coverage of Veeva Vault; adaptive intelligence for MasterControl, TrackWise, SAP QM, Medidata, LIMS platforms, and custom GxP applications.
Wardian is continuous validation infrastructure for life sciences IT and Quality teams. It keeps a living model of every validated GxP system you run and continuously matches your requirements against every vendor release, configuration change, and in-house feature addition as it lands, classifying regulatory impact with a full reasoning chain and citations and keeping audit-ready evidence current — replacing 200–500+ hours a year of manual upgrade documentation per company.
Continuous compliance is the practice of maintaining audit-ready evidence as a persistent state rather than reconstructing it for each audit. Instead of a quarterly or annual sprint to gather documentation, every vendor change, configuration edit, and regulatory update is matched against your requirements and recorded as it happens, so "are we compliant right now?" is always answerable in seconds.
Computer System Validation (CSV) is the traditional document-heavy approach to qualifying GxP software, defined by GAMP 5 and decades of FDA practice. Computer Software Assurance (CSA) is the FDA's 2022 draft guidance that asks teams to apply critical thinking and risk-based testing instead of producing exhaustive documentation for low-risk changes. Wardian implements CSA-aligned workflows: every change gets a risk-graded analysis with reasoning, and only the changes that meaningfully impact patient safety, product quality, or data integrity get the full validation treatment.
Wardian continuously watches vendor release feeds, configuration edits, and in-house change records, then matches every change against a living model of your exact requirements and configuration (modules in use, integrations, regulatory scope), and outputs a classification — No Impact, Indirect Impact, or Direct GxP Impact — for every change. Each classification ships with a full reasoning chain, regulatory citations (21 CFR Part 11, EU Annex 11, GAMP 5), a confidence score, and a list of items that need human review.
Wardian is GxP-adjacent intelligence: it produces draft impact classifications that a qualified human reviews and approves, and the reviewer's decision is the GxP record. Wardian publishes a 14-pillar Validation Outline covering intended use, model and prompt lifecycle control, evaluation methodology with acceptance criteria, human-in-the-loop controls, an immutable 21 CFR Part 11 / EU Annex 11 audit trail, and processing transparency — all backed by an Auditor Packet with a SHA-256 verifiable bundle.
Wardian is built for pharmaceutical, biotech, and medical device companies that run a stack of validated GxP software — typically 4–8 systems per company — and currently spend 200–500+ hours a year reading vendor release notes, writing impact assessments, and preparing audit evidence. The primary buyers are Heads of Quality, IT Directors, Validation Leads, and CSA/CSV consultants.
Ryan spent a decade implementing validated GxP systems at life sciences companies before founding the platform. We operationalize FDA Computer Software Assurance (CSA) and ISPE GAMP 5 (2nd ed.) at scale. The platform is built and operated directly — no third-party data brokers, no outsourced model training. Reach the founder at ryan@getwardian.com.