GMP assessments
Structured self-assessments that turn an uneasy feeling into a position: a weighted score, a domain breakdown, and the two areas carrying most of your exposure.
Answer honestly rather than aspirationally. A score is only useful if it tells you something you did not already want to hear.
Available now, and in development
GMP Readiness Assessment
Twenty questions across seven quality-system domains. Returns a weighted score, a domain breakdown, and names the two areas carrying most of your exposure.
OpenCAPA Maturity Assessment
Intake, investigation quality, effectiveness criteria and backlog control, scored as a maturity position rather than pass/fail.
Question set drafted; needs practitioner review before publication.
Data Integrity Assessment
ALCOA+ coverage across paper, hybrid and electronic records, including audit trail review and access control.
Scoring must align to PIC/S PI 041 domains; needs review.
Inspection Readiness Assessment
Retrieval speed, back-room function, narrative consistency and closure of previous commitments.
Overlaps the readiness score; needs de-duplication before launch.
QMS Assessment
Whether the quality system functions as a connected system rather than a set of separate procedures.
Question set not yet drafted.
Operational GMP Risk Assessment
Release predictability, deviation load, audit programme execution and third-party dependency.
Question set not yet drafted.
Supplier GMP Risk Assessment
Tiering, qualification currency, quality agreement coverage and change-notification performance.
Question set not yet drafted.
Executive GMP Risk Assessment
A short executive-level triage covering licence exposure, supply dependency, resourcing and governance.
Question set drafted; deliberately short, needs executive review.
What an assessment is, and is not
These are structured self-assessments and educational risk-triage tools. They reflect what you report about your own system. They are not audits, not regulatory determinations, and they produce no certificate. A low score does not mean you are non-compliant; a high one does not guarantee an inspection outcome. Completing an assessment confers no regulatory compliance status of any kind.
Start with the readiness score
Twenty questions across seven quality-system domains, about ten minutes, calculated in your browser with nothing submitted.