Guide · 8 min · 2026-07-23
Pharma software validation readiness: what to prepare before IQ/OQ/PQ
A practical buyer checklist for regulated software validation—requirements, risk, environments, and evidence—without claiming the vendor validates your site for you.
Validation is your program, not a brochure claim
Vendors can supply documentation and a system designed for GxP themes. Your quality system, risk assessment, and executed protocols decide whether the validated state is defensible. Ask for clarity on what the supplier provides versus what your team owns.
Freeze the intended use early
Write down which processes the software will support—document control, training, quality events, batch records—and which sites go first. Ambiguous scope creates endless protocol rewrites.
Environments and change control
Agree how Production and Training (or similar) instances are separated, how configuration moves between them, and who signs off. Inspection conversations often land here.
Evidence you will need on site
Requirements traceability, risk assessment, IQ/OQ/PQ protocols and reports, training for system owners, and a clear path for post-go-live changes. If a demo cannot show audit trails and e-signatures in context, note the gap.
How Novaqis fits the conversation
Novaqis is built for Part 11 and Annex 11 themes and customer-managed deployment. We support validation with product clarity and walkthroughs—not a claim of automatic regulatory approval. See For validation & IT and Contact for a scoped discussion.
Ready to see Novaqis on your terms?
We prefer live walkthroughs over generic slides. Ask for a demo or a tailored quote—no published list prices.