AI Regulatory Writing Software RFP Template

Resource: Version 1.0, September 14, 2026. The complete workbook is provided as editable, copy-ready tables in this article; no download or registration is required. Copy each worksheet into your preferred document or spreadsheet. Bracketed entries are fields to complete. The example is fictional. This is Assyro's procurement resource, not an official agency form, certification checklist or legal contract.

Worksheet 1: define the purchase

Complete these fields before issuing the same workbook to vendors. Keep this scope attached to every response so an attractive demonstration cannot silently change the purchase.

Specify work at the level the vendor can demonstrate. “Draft defined CSR sections from approved tables and narrative sources” is more useful than “automate medical writing.” If authoring is the purchase, do not implicitly include publishing, gateway transmission or registration management without separate requirements.

Worksheet 2: requirements and evidence

These are proposed starting requirements. Your owners should confirm which are mandatory, revise the criteria for the intended use and add requirements missing from the table. They are not assertions that all organizations have identical regulatory obligations.

The rationale for investigating AI-specific risks is broader than this software category. NIST's July 2024 Generative AI Profile discusses risks and suggested management actions across the AI lifecycle. It is a voluntary, cross-sector resource; it does not make this workbook a regulatory standard or endorse a product. NIST AI 600-1.

Expand storage, processing and deletion questions with the AI medical-writing security checklist.

Worksheet 3: require a structured vendor response

Ask each vendor to repeat this record for every requirement. Keep its response separate from the buyer's disposition.

“Available” is a vendor position, not an automatic pass. Roadmap items remain future scope. If a service team performs a task, evaluate that service and its handoff instead of recording the behavior as an intrinsic software feature.

Avoid combining several independently failing requirements in one response. A product may preserve comments but lose tracked deletions; those can require separate acceptance rows even if both started under R05.

Worksheet 4: score preferences after the gates

First check mandatory requirements. A failed mandatory requirement means the proposed arrangement is unsuitable for that requirement. An unresolved mandatory requirement means the selection decision remains open. Neither can be offset by the preference score.

For candidates whose mandatory requirements pass, the following optional weights provide a starting point. Agree them before comparing responses. These are editorial choices, not validated predictors of business outcomes.

Use a 0–4 evidence-based rating: 0 does not meet the stated preference; 1 has substantial limitations; 2 meets it with material manual work; 3 meets it with manageable limitations; 4 meets the agreed preference with no material limitation observed in the evaluation. This scale concerns the tested scope, not perfection or universal capability.

For a completed scorecard, each contribution equals weight × rating ÷ 4. The weights total 100, so contributions sum to a score out of 100. Do not calculate a final score when a required rating or its evidence is missing. Keep the denominator unchanged while the question is unresolved; dropping an unanswered dimension would make incomplete evidence look stronger.

Completed example: a high score cannot close an evidence gap

Fictional Candidate A receives ratings of 3, 4, 2, 3 and 4 in the order above. Its contributions are 22.5, 25, 10, 11.25 and 10, totaling 78.75/100.

However, the buyer marked R04 mandatory and the vendor has not shown how conflicting sources are handled. The recorded decision is unresolved mandatory requirement; preference score does not authorize selection. It is not a passing result.

If the exercise later passes, retain the evidence and change that requirement's disposition. If it fails, record the specific behavior and requested correction. Do not retrospectively relabel a mandatory requirement as optional simply to preserve a favored candidate's score.

Worksheet 5: normalize the commercial response

Request an amount or an explicit unresolved entry for each relevant item. Record currency and term with every quote. Optional items should remain identifiable.

An unquoted mandatory item is not zero. Compare the same workload and contract term before interpreting differences in price. Keep any estimated internal effort clearly separate from a supplier's actual quote.

Use the workbook in a controlled evaluation

Confirm the scope, classifications and weights with the responsible stakeholders. Send the same version to each candidate. Collect responses, then choose a small demonstration that tests the most consequential unresolved requirements. Retain the output and the reviewer's observation with the relevant row.

Before deciding, check that exclusions have owners and reasons, mandatory requirements have evidence, arithmetic reconciles, and the commercial response covers the demonstrated configuration. Include both a straightforward success case and a deliberate missing-input or conflict case. The latter often clarifies responsibilities that a polished demonstration leaves implicit.

Assyro is our first candidate to evaluate for connected regulatory authoring and preparation, subject to these same requirements. Bring your completed scope worksheet to an Assyro discussion. Use the resulting evidence record to decide the specific configuration and operating arrangement your team can accept.

Use the AI writing qualification guide when translating the demonstration record into permission for a defined production use.