Choosing Regulatory Software: Buyer’s Guide and RFP Question Bank
Choosing regulatory software
A vendor-neutral way to scope, evaluate and choose — with the questions regulatory, IT and quality evaluators should each ask, and a demo script that uses your own content.
Three common mistakes
Scope set by a product list
Start from the team’s work — planning, documents, publishing, validation, review, commitments — not from what one vendor sells.
Nobody owns the joins
Each evaluator checks their area. The failures happen between them: the published document is not the approved one; the plan and the sequence disagree.
The vendor’s demo on the vendor’s data
Send a script and your own content in advance. A demo that only works on sample data proves very little.
Licence cost mistaken for total cost
Implementation, migration, validation and your own team’s time usually exceed the first two years of licences.
Eight questions worth asking every vendor
- Which regions can you publish to today, at which Module 1 versions? Show the list, not a roadmap.
- Will your validator check a sequence your tool did not build?
- Can you import our existing sequences with full lifecycle history? How is the import verified?
- Is the version published guaranteed to be the version approved? How?
- Deployment model: multi-tenant cloud, single-tenant, on-premise? Where is our data hosted, and can we choose the region?
- If we leave, in what format do we get our sequences, documents, metadata and audit trails back, and how long does it take?
- Can the audit trail be filtered, exported and read by an inspector without vendor help?
- What is included in implementation, and what is billed separately: migration, validation, integration, training?
Make every vendor do the same eight things
One of your existing sequences, with lifecycle history.
The next sequence for a region you file in, from your data.
Replace two documents and delete one, from the cumulative view.
Add a broken link and a secured PDF. Are they caught before validation?
Validate at the region’s severity, show the reviewer’s view, export the audit trail, show the plan updated.
The full guide and question bank
For regulatory, IT, quality and procurement evaluators.
- The capability map: what a regulatory function needs, and the joins between
- 33 RFP questions in six groups, one per evaluator
- An eight-step demo script that uses your content
- A total-cost model with the questions to ask on each line
- A scoring frame and six red flags
Frequently asked
Should we buy one platform or separate tools?
Either can work. Separate tools need their integrations evaluated as seriously as the tools; a single platform needs each capability to be strong enough on its own. The deciding question is usually whether the published document is guaranteed to be the approved one, and whether the plan and the sequence stay in step.
How long should an evaluation take?
For a focused team, six to ten weeks: two to write requirements and send the script, two to four for scripted demos, and two for references, security review and commercial terms.
What should IT focus on?
Deployment and data location, how customer data is separated, single sign-on, APIs, release cadence and impact assessment, recovery objectives, and how you get your data back if you leave.
Run the demo script on DnXT
Send us the eight steps and a sample of your content. We will run them on DnXT — planning, documents, publishing, validation and review in one platform.
