Guide · 8 min · 2026-07-23
RFP checklist for regulated pharmaceutical software
A practical vendor due-diligence checklist for GxP document, training, and quality systems—deployment, identity, audit trails, and commercial predictability.
Ask for a live path, not a feature PDF
Write three end-to-end scenarios from your SOPs. Ask every vendor to run them in a working system. Slides hide gaps that a live walkthrough reveals in minutes.
Identity and segregation of duties
Who creates users? How are roles separated across documents, training, and quality? Can partners get limited access without a second directory?
Deployment and residency
Must the system run on your servers? What does offline license activation look like? Where does any AI assistant run?
Electronic records themes
Signatures, audit trails, and corrections should be explainable to inspectors. Ask to open the trail beside a real approval.
Commercial model under growth
Model five years of users and plants. Seat and plant fees often dominate. Prefer predictable models—and get a written quote rather than brochure numbers.
Proof in your network
A short POC on your infrastructure with your sample documents beats a hotel conference room demo. Involve QA, IT, and at least one floor user.
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.