Sponsor questionnaires answered from your evidence, approved by QA
Sponsors often qualify a CRO before they place work, and that can mean a long questionnaire on your quality system, GLP status, inspection history, computerized systems, data integrity, IT security and AI use, followed by an audit. Most answers already exist in your SOPs and past questionnaires. The agent finds them, drafts each answer with its evidence attached and leaves QA to approve.
Examples use invented names and figures.
What the agent does
- Step 1Reads the questionnaire
Word, Excel, PDF or a portal export. Each question is split out and tagged by topic, such as GLP status, computerized systems, archives, subcontractors or AI use.
- Step 2Matches approved answers
It searches only your approved answer library and the evidence behind it: the SOP index, inspection history, validation summaries, policies and answers QA has approved before.
- Step 3Drafts with evidence
Each answer cites the document it came from. Questions with no approved answer, or that ask for a new commitment, are marked for QA with the reason instead of answered.
- Step 4Queues it for QA
QA approves or edits each answer. Approved answers go back into the library with a date and version, so the next questionnaire starts further along. For audits, the agent assembles the document pack from the sponsor's agenda.
QA approves every answer before it leaves. Commitments to change a process and anything about open inspection findings or CAPAs stay with your quality team. So does the audit itself. The agent drafts from approved evidence only and never writes a new commitment.
- QA hours per questionnaire
- Days from questionnaire received to returned
- Share of answers reused without edits
- Follow-up questions from the sponsor
Questions about this agent
What goes into the answer library?
Answers QA has already approved, plus the documents behind them: SOP titles and numbers, your GLP status, the inspection history you are willing to share, validation summaries for key systems, IT security and continuity summaries, and your AI tool register. We build the first version from your last few completed questionnaires.
Can it answer questions about our own AI use?
It drafts them from your AI policy and tool register, like any other section. If you do not have those yet, our AI governance for life sciences work puts them in place, and the agent then answers from them.
Does it fill in sponsor portals?
It prepares answers you can paste or upload. Some portals accept an Excel import and some do not. We check yours during scoping and pick the path that keeps QA approval in front of every answer.