Example data expectation. Example data should reflect a credible pre-inspection position: some controls inspection-ready, some amber gaps, named weak areas and practical preparation actions that can be transferred into the QMS or inspection readiness plan.
Method boundary. Readiness scores and bands are a RegOpsPro preparation framework, not an MHRA inspection rating or assurance of regulatory compliance.
How to use the scorecard
Work through a guided readiness workflow rather than a cramped input panel. Estimated completion time is 20–30 minutes depending on evidence depth.
- Scope: 3–5 min to define site and assessment boundary.
- Scoring: 10–15 min to score GDP readiness controls.
- Governance report review: 5–7 min to review priority gaps and actions.
- Export: 2–3 min to copy, print or transfer outputs.
How to interpret the output
The scorecard converts individual control-area scores into an overall readiness band, recommended preparation priorities and a QMS-transfer summary for action tracking and internal review.
- Not inspection-ready: major preparation gaps remain.
- Significant preparation required: core controls or evidence need work.
- Targeted preparation required: selected gaps need closure before inspection.
- Inspection-ready: evidence is broadly organised and explainable.
RegOpsPro™