How SPEQ derives its intelligence.
Practitioner-grade only works if it is honest. This is where SPEQ’s data comes from, what it reports verbatim, what it interprets, and the rules that keep the two clearly separated.
Primary sources, cited.
102 standards decoded across 35 bodies — FDA, EMA/EU GMP, ICH, WHO, USP, ISO, ISPE, PIC/S, MHRA, Health Canada, TGA, PMDA. Every code is quoted, never paraphrased into inaccuracy.
Live FDA drug and device recall records pulled from the openFDA enforcement API. The recall text, classification, firm, and dates are FDA’s, reproduced as-is.
FDA rules and notices (including QMM program notices) from the Federal Register API, filtered to Food and Drug Administration documents.
“Quality Management Initiatives in the Pharmaceutical Industry: An Economic Perspective” (July 2025). Every economic figure and quote SPEQ shows is cited to it.
The five practice areas, the 10-point-scale intent, and the pilot history are FDA program facts, cited to the QMM program pages and Federal Register notices.
We keep the record and our reading of it separate.
Everything on the left is a primary-source fact. Everything on the right is SPEQ’s interpretation on top of it — useful, but always labelled as ours.
- ✓Regulatory clause and code references (e.g. 21 CFR 211.68, EU GMP Annex 1 §4, ICH Q9(R1)) — quoted verbatim.
- ✓FDA recall records — classification, recalling firm, reason, and dates exactly as openFDA publishes them.
- ✓Economic figures and quotes — reproduced from the FDA/OPQ white paper with page citations.
- ✓FDA QMM program facts — the five practice areas, the 10-point scale, and the pilot timeline.
- ✓Site metrics — every count shown in the UI (standards, tools, templates, layers) is derived from the underlying data, never rounded up.
SPEQ maps each recall’s reason text to one of 5 quality-signal domains (Documentation & Change Control, Risk Management & CAPA, Validation & Qualification, Environmental Monitoring, Data Integrity). This is SPEQ’s reading, not an FDA classification, and it is labelled that way everywhere it appears.
SPEQ’s five-level scale is aligned to ICH Q10, EU GMP, and FDA expectations for an effective pharmaceutical quality system — but the scoring rubric and level definitions are SPEQ’s own.
SPEQ maps its assessment domains onto FDA’s five QMM practice areas as a practitioner on-ramp. The mapping — and the illustrative 1–5 → 10-point conversion — is a SPEQ interpretation, never an official FDA QMM score.
The CoPQ calculator applies the improvement ranges the FDA white paper observed in its case studies (defects −50%+, waste −75%) illustratively. It is a directional business case, not a projection or guarantee.
Transparent scoring, no black box.
Each assessment question maps to a maturity level from 1 (Foundational) to 5 (Optimized). A domain’s score is the average of its questions, and your overall level is the average across domains. The Quick Scan covers five foundational domains; the Comprehensive assessment extends to all twelve domains.
The rubric is aligned to ICH Q10, EU GMP, and FDA expectations for an effective pharmaceutical quality system. Your domain scores also roll up into FDA’s five QMM practice areas as a readiness view — an illustration of where you would sit, not an official FDA QMM score.
The rules we hold the content to.
Never fabricate
No placeholder content, no invented regulatory data, no aspirational statistics. If a figure can’t be cited to a real source or derived from real data, it does not ship.
Label every interpretation
Wherever SPEQ adds a reading on top of a primary source — a mapping, a score, an estimate — it is marked as a SPEQ interpretation so it is never mistaken for the underlying record.
Metrics derive from data
Counts and stats are computed from the underlying arrays at build time, so the numbers on the page can never drift from the catalogue behind them.
Cite the source
Regulatory codes, recall data, and economic figures each carry their attribution. The reader can always trace a claim back to FDA, EMA, ICH, openFDA, or the white paper.
The regulatory feed refreshes on a schedule.
An automated scanner pulls FDA enforcement and Federal Register activity on a weekly cadence. Until a live scan runs, the feed shows curated milestones clearly marked as such — never fabricated data standing in for real activity.