Where is your quality system today — and where does it need to go?
The SPEQ Maturity Model scores your quality system across 5 domains in the Quick Scan — up to 12 in the Comprehensive assessment — over five maturity levels, then maps your gaps to a clear remediation roadmap. Built for GxP teams across manufacturing, clinical operations, lab systems, validation, QA, QC, and regulatory.
A structured way to measure — and grow — your quality system.
A quality systems maturity model describes the journey every regulated organisation travels — from reactive, document-driven compliance to a predictive, data-driven quality culture. The SPEQ Maturity Model turns that journey into something you can measure.
It assesses your organisation across five practitioner domains and scores each against five maturity levels — aligned to ICH Q10, EU GMP, and FDA expectations. The result is an honest baseline, a clear set of priorities, and a roadmap your leadership team and your auditors will both recognise.
Know exactly where you stand
An objective, evidence-based score across five quality domains — not a gut feel. See your maturity the way an inspector or an auditor would.
Find your gaps before a regulator does
Pinpoint the specific domains dragging your quality system down, ranked by risk and inspection exposure — so you fix what matters first.
Build a defensible improvement roadmap
Translate scores into a prioritised remediation plan, each gap mapped to the SPEQ templates, standards, and tools that close it.
FDA Quality Management Maturity
FDA now rates quality management maturity beyond CGMP compliance. Your assessment maps to its five practice areas — the practitioner on-ramp to a voluntary QMM assessment.
What QMM is →The economics of quality
FDA’s 2025 white paper shows maturity is a return on investment, not a cost — defects down 50%+, waste down 75%. See the curve, and put a number on your own cost of poor quality.
Why it pays →Five levels of quality system maturity.
Every regulated organisation sits somewhere on this scale. Select a level to see what it means for your inspection posture — and what it takes to advance.
Structured, proactive, inspection-ready.
Controlled risk — a defensible quality system that passes routine inspection.
Commercial manufacturers with an established QMS and a track record of clean inspections.
Instrument your processes with metrics and trending to move from managed to measured.
What the assessment measures.
Your maturity is scored across five domains that together define a regulated quality system. Each is mapped to the standards an inspector will cite.
Documentation & Change Control
How your quality documents are controlled, versioned, and how changes are reviewed and approved across the site.
Risk Management & CAPA
How proactively you identify quality risks and how effectively your CAPA system prevents recurrence.
Validation & Qualification
The structure of your equipment, process, and computer system validation programmes across the lifecycle.
Environmental Monitoring
How your EM programme is designed, justified, executed, and how excursions are investigated and trended.
Regulatory Intelligence
How your organisation stays current with evolving requirements and maintains continuous inspection readiness.
What each level looks like, domain by domain.
The same 1–5 scale, made concrete. Pick a domain to see the observable evidence a practitioner (or an inspector) would expect at each maturity level.
No formal system — printed copies, email distribution
Documented SOPs exist but reviews are ad hoc
Formal DMS with scheduled review cycles and training records
Validated electronic DMS with metrics, trending, and periodic effectiveness review
Predictive, self-service DMS: automated review scheduling, real-time control metrics, and continuous-improvement feedback across the network
Rubric text is drawn from the assessment questions themselves — the wording you answer against.
Every domain in depth →From baseline to roadmap in five steps.
The assessment is built to produce something useful — not just a number, but a defensible plan you can act on the same day.
Assess
Answer a short series of questions describing how your quality system operates today — not how you wish it operated. Each question targets a specific, observable capability.
Score
SPEQ calculates your maturity level for each domain and an overall score, rendered as a radar chart you can read at a glance and share with leadership.
Identify gaps
Your lowest-scoring domains are surfaced as priority gaps, framed in the language inspectors use — so you know precisely where your exposure sits.
Roadmap
Each gap is mapped to the exact SPEQ templates, standards, and tools that close it. The output is a remediation plan you can put in front of your quality council.
Track
Re-assess on a quarterly cadence to evidence improvement over time. Team and Enterprise plans roll multiple sites into a single benchmarked view.
Choose the depth that fits your organisation.
Start with the Quick Scan, then use the deeper diagnostic and resource map to shape your GxP improvement roadmap. SPEQ resources are open while the information hub is being built.
Quick Scan
Get a baseline in ten minutes.
Anyone exploring where their quality system stands today.
Comprehensive Assessment
A full diagnostic with a defensible report.
QA leads building a remediation roadmap they can defend to leadership.
Multi-Site & Advisory
Measuring maturity across multiple sites.
Quality organisations planning to measure and compare maturity across several sites.
Whether you're building or scaling.
The same model serves a two-person startup and a global manufacturing network — the difference is how you use the result.
Building a quality system from the ground up
You are standing up GMP capability for the first time — often under investor and clinical-timeline pressure. The model tells you which controls to build first, so you spend limited resources where they reduce the most risk.
Benchmarking and improving at scale
You operate a mature QMS across one or many sites. The model gives you an objective, comparable measure of maturity — site to site, quarter to quarter — and a shared language to drive continuous improvement and defend your state of control.
Quick Scan or Comprehensive. Instant results.
Select the option that best describes your current state — not your aspirational state. Honest answers produce a useful baseline. Nothing is saved unless you choose to.
Quick Scan needs no account. Comprehensive requires a free sign-in.
Questions, answered.
Get your baseline in ten minutes.
The Quick Scan takes no account, and gives you an honest, actionable view of where your quality system stands today.
Start Quick Scan →