RegOpsPro™
RegOpsPro™AI Use Boundary
RegOpsPro AI is a drafting and challenge-testing layer for GDP work. It helps users structure wording around supplied facts, evidence gaps and GDP control themes, while keeping practical judgement, approval and QMS control with the user.
Appropriate uses
- Draft governance summaries from supplied facts.
- Improve CAPA, inspection and supplier oversight wording.
- Challenge-test a draft decision for missing evidence or overclaims.
- Identify GDP control themes that may be relevant to the record.
- Highlight uncertainty, assumptions and follow-up actions for review.
Not appropriate uses
- Making RP, RP-I, QA, QP or product-status decisions.
- Approving release, rejection, recall, CAPA closure or QMS closure.
- Inventing evidence, supplier details, batch facts or inspection outcomes.
- Providing legal or regulatory advice.
- Replacing your organisation's QMS procedures or required approvals.
What users see in AI-supported outputs
Where AI is used, outputs are designed to make the drafting logic visible:
- GDP control themes applied — for example RP accountability, product integrity, traceability, supplier oversight, CAPA, recall readiness, inspection readiness or governance review.
- Evidence gaps / uncertainty — what remains unclear and what should be confirmed before use.
- QMS transfer caution — a reminder that the output is draft wording for practical review before controlled use.
Data boundary
Use non-sensitive inputs unless your organisation has approved the use of specific information in AI tools. Do not enter confidential product, batch, supplier, customer, patient, staff, inspection or authority-sensitive information unless approved by your organisation.
How to handle AI-supported outputs
- Treat AI output as draft wording.
- Review the wording before use.
- Check facts, evidence, assumptions and risk statements.
- Remove unsupported claims.
- Transfer only reviewed and approved wording into controlled QMS records.
Standard AI boundary: AI supports drafting and challenge-testing only. Review all output before use. Do not transfer AI wording into controlled QMS records until reviewed and approved through the relevant QMS process.