ValiChain

ValiChain is a web app (with optional tablet-friendly UI) that helps biologics teams assemble, version, and defend process validation and continued process verification (CPV) evidence without living in spreadsheets and scattered PDFs. It provides structured templates for PPQ/CPV plans, links each acceptance criterion to raw data files and calculations, and generates an audit-ready “evidence pack” with traceable approvals and change history. The app focuses on the painful middle layer between MES/LIMS (data generation) and eQMS (quality records): organizing proof that the process is in control. It supports common biologics workflows like titer, impurity clearance, hold-time studies, filter integrity, and mixing/temperature excursions. Expect integrations to be limited in MVP; most value comes from disciplined evidence linking, controlled calculations, and reviewer workflows. This is a traditional app with AI assistance for document drafting and gap-checking, not an “AI runs your validation” fantasy.