Regulatory
Assessment
Every requirement,
checked against your documentation.
Regulations and standards change, and documentation accumulates across teams and systems. AskDona Assessment reads your SOPs, technical files and records against each applicable requirement and returns a first-pass judgment with the reason, the quoted evidence and its source, and what could not be found, so your QA and RA experts can focus on the gaps.
Having a procedure is not the same as showing a requirement is met.
A regulatory assessment asks the same precise question of every requirement: do our procedures, records and technical documentation show that it is met?
The answer is spread across SOPs, work instructions, design files and quality records, many of them written before the current requirement took effect. Finding the passage, judging whether it is enough and recording why can take hours per requirement.
Aren't you rebuilding the same evidence trail at every audit, submission and regulatory change?
AskDona Assessment
Take assessments into an era
you run together with an AI agent.
Evaluations once done one at a time, by hand —
now run all at once by an AI agent, grounded in the evidence.
AskDona Assessment returns the judgment and its evidence, in the same row.
Register the requirements you assess against (regulations, standards, guidance or internal policies) and the documentation to assess. For each requirement, an AI agent prepares a first-pass judgment, the reason, the passages it quotes with their file and page, and the information it could not find.
Every quotation is checked against the document it cites, and a requirement with no supporting passage is marked cannot determine rather than met. Your QA and RA reviewers start from the evidence and the gaps, not from a blank search.
For each requirement, everything a reviewer needs to check it.
| Output | What your reviewer can confirm |
|---|---|
| Requirement | The clause or requirement being assessed, as your team registered it |
| Judgment | Satisfied, not satisfied or cannot determine, on the labels you define |
| Reason | Why the evidence does or does not meet the requirement |
| Evidence | The passages quoted verbatim, each with its file and page |
| Gaps | What the documentation does not yet show |
| Review points | Where a reviewer should look first |
ギャップを、
根拠とともに。 Find the gaps,
with the evidence.
御社の手順書と要求事項でお試しください。Try it on your own procedures and requirements.
Frequently asked questions
The ones your team registers: for example FDA QMSR and 21 CFR Part 820, ISO 13485, EU MDR, GMP requirements, or your internal policies. You define the requirements and the labels.
No. It prepares a preliminary, evidence-linked assessment. Qualified QA and RA professionals interpret the requirements and make the compliance decision.
Each quotation is located in the document it cites before the result is shown. A quotation that cannot be found is removed, and if no evidence remains, the criterion is marked cannot determine.
With the same documents, criteria and configuration, yes. The Assessment Engine behind AskDona Assessment is built to return the same assessment, byte for byte, so any later difference can be traced to a change.
The requirement is flagged for further review, with what could not be found. Missing evidence is not treated as proof of compliance, and a document that was not found is not treated as proof that a record does not exist.