About Valready
Valready is an AI-assisted Computer System Validation (CSV) documentation platform — every document is reviewed by a human before release.
What we do
Valready helps produce computer system validation documentation: the URS, functional risk assessment, IQ/OQ protocols and the requirements traceability matrix (RTM) — linked to each other instead of scattered across dozens of files.
It comes in two forms: a subscription tool (Workspace), where your own team runs the documentation and its review, or a one-off validation sprint, where our CSV expert reviews the documents for you. Either way, your Quality Unit approves them in your QMS.
Who writes on this site
The articles on the blog are written by M.A., Validation Lead.
The areas we work in:
- Computer System Validation (CSV)
- GAMP 5
- FDA 21 CFR Part 11
- EU GMP Annex 11
- EU GMP Annex 22 (AI/ML, draft)
- ALCOA+ data integrity
Principles we hold to
- AI never approves. AI only prepares drafts. A person makes the decisions.
- A human reviews every document. In the sprint our CSV expert, in Workspace your own team — before anything leaves the tool.
- A draft until your QMS. Every export is marked “DRAFT — NOT APPROVED” and carries its AI provenance.
- Data in the European Union. Production runs in the EU. We never train models on customer data.
Contact
Write to us: contact@valready.com
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