What Valiqa does?
Valiqa is an AI-powered validation protocol generator for regulated manufacturing. It produces audit-ready IQ, OQ, PQ, DQ, and PPQ protocols, plus Validation Master Plans, in minutes instead of weeks.
Who it is for?
Quality, validation, and regulatory teams at medical device, pharmaceutical, biotech, and food manufacturers. Built for the small and mid-sized companies that need FDA and ISO-grade documentation without an enterprise validation-suite budget.
What you get?
Why teams choose Valiqa?
Traditional validation lifecycle platforms are expensive, slow to deploy, and built for large enterprises. Valiqa delivers the same audit-ready output in minutes, self-serve, at a fraction of the cost. Know your process. Prove your compliance. Ship faster.
A startup from the United States.
IQ / OQ / PQ generation
Audit-ready installation, operational, and performance qualification protocols in minutes
DQ and PPQ support
Design qualification and process performance qualification documents
Validation Master Plan
Full VMP generation scoped to your equipment and process
Regulatory alignment
FDA 21 CFR Part 11, ISO 13485, GMP, and MDSAP-ready output
International standards
UK, EU, India, Korea, Mexico, Brazil, and ISO 9001 coverage
Document grounding
Protocols built from your uploaded equipment specs, not boilerplate
Legacy and AI-native enterprise platforms alike are demo-gated, slow to implement, and built for large enterprises. Valiqa gives you generation, e-signature, audit trail, and deviations in one self-serve platform, audit-ready in minutes, transparent pricing from $149/mo.
Valiqa was built by a manufacturing automation engineer who spent years writing validation protocols by hand and watched teams lose weeks to documentation that followed the same predictable structure every time. Existing software solved this only for large enterprises with enterprise pricing and a multi-month implementation. Valiqa was created to give every regulated manufacturer, regardless of size, fast and audit-ready validation documentation without the enterprise price tag.
Valiqa runs on a Go backend with a PostgreSQL database and a modern web app. Document generation combines large language models with a purpose-built validation prompt-and-section architecture and a deterministic builder for audit-ready formatting and export.
The self-serve validation platform you can sign up for and use today, no demo, no six-figure rollout. It generates equipment-specific protocols in minutes and runs them through e-signed, audited approval in one place.
Quality, validation, and regulatory affairs professionals at medical device, pharmaceutical, biotech, and food manufacturers. The core user is the small to mid-sized regulated company that needs FDA and ISO-grade validation documentation without the budget or headcount for an enterprise validation lifecycle platform.
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