Wardian: Continuous validation infrastructure for life sciences IT
Every customization, configuration change, and in-house extension you have ever added is still on the books. Wardian is continuous validation infrastructure for life sciences IT and Quality teams. It keeps a living model of every validated GxP system you run, surfaces drift the moment it happens, and writes the validation documents each change requires, with full reasoning, citations, and a qualified reviewer approving every decision. Teams get back 200–500+ hours of manual upgrade documentation a year.
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 handles the compliance work each change creates, covering vendor releases, configuration changes, and in-house feature additions. When something changes, Wardian classifies the impact with reasoning and citations, drafts the supporting documents, and keeps evidence current. A qualified human approves every decision. Teams get back 200–500+ hours of manual documentation a year.
Continuous compliance means paying down customization debt as it accrues rather than rediscovering it before each audit. Every change is matched against your requirements and recorded when it lands, 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 Computer Software Assurance (CSA) is the FDA's 2022 draft guidance asking teams to apply critical thinking and risk-based testing rather than exhaustive documentation for low-risk changes.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 classifies every change as No Impact, Indirect Impact, or Direct GxP Impact. 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 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, with no third-party data brokers and no outsourced model training. Reach the founder at ryan@getwardian.com.