What SPEQ has decoded, and what it has not.
A reference estate is only worth trusting if you can see its edges. This page is generated from the catalogs themselves — every figure below is counted at build time, so none of it can drift away from what the site actually contains. Where an entry is listed but not yet decoded, it is named here and linked.
Standards →
A decoded entry in the authored standard-content module — scope, what it requires, and what an inspector asks.
Topic explainers →
Every explainer is authored prose by construction — a topic without sections and an FAQ cannot exist in the catalog, so this row cannot be anything but complete.
Document templates →
Purpose, what is inside, how to use it, regulatory context and a section outline.
Interactive tools →
The formula with every symbol defined, a worked example, the regulatory basis, and the limitations that say what the tool is not.
Disciplines →
Scope, why it matters, focus areas and what inspections concentrate on.
Industries →
Scope, the regulatory landscape, focus areas and the failure modes that recur.
Value-chain sectors →
Scope, the regulatory landscape, the sponsor-to-provider oversight model, and failure modes.
Regulatory bodies →
Mandate and legal instrument, how its requirements acquire force, what it publishes, and where practitioners get it wrong.
System classes →
Every system class is authored prose by construction — the catalog entry IS the decode, so this row cannot be anything but complete.
Lifecycle phases →
A phase counts as covered when all four axes resolve — standards, disciplines, systems and topics — with real standards depth. The phases named below are mapped but thin.
Where the axes cross
A catalog tells you what SPEQ covers. It does not tell you where two of those things meet and become harder than either alone — validating a learned model under a GMP validation programme, or running an eTMF against sponsor oversight. Each cell below is a written intersection, not a search: a cell that could only offer these four standards would be a filter with extra steps, so an unwritten crossing shows as empty rather than being filled with a query.
11 of 50 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
9 of 40 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
7 of 14 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
6 of 12 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
| Discipline | Clinical Quality (GCP) | Data Integrity | Documentation & Change Control | Environmental Monitoring | Risk Management & CAPA | Validation & Qualification |
|---|---|---|---|---|---|---|
| GCP | CTMS × Sponsor Oversight → | EDC × Data Integrity → | eTMF × Inspection Readiness → | · | · | · |
| GMP | · | · | · | Contamination Control × Environmental Monitoring → | Supplier Quality × Outsourced Manufacturing → | AI in GMP × Quality Maturity → |
9 of 45 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
6 of 36 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
6 of 30 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
4 of 8 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
| Discipline | CDMOs & Contract Manufacturers | Distribution & Logistics | Excipient & Raw-Material Suppliers | Packaging, Labeling & Serialization |
|---|---|---|---|---|
| GDP | · | Cold-Chain Distribution × Serialization → | · | Serialization × Good Distribution Practice → |
| GMP | Supplier Quality × Outsourced Manufacturing → | · | Supplier Quality × Excipients → | · |
4 of 16 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
| System | Clinical Quality (GCP) | Data Integrity | Documentation & Change Control | Validation & Qualification |
|---|---|---|---|---|
| AI/ML Systems in GxP | · | · | · | AI in GMP × Quality Maturity → |
| CTMS | CTMS × Sponsor Oversight → | · | · | · |
| EDC | · | EDC × Data Integrity → | · | · |
| eTMF | · | · | eTMF × Inspection Readiness → | · |
3 of 6 crossings on this pair are written. An empty cell is a crossing SPEQ has not authored yet — not a filter it declined to run.
| System | Change Control | Data Governance |
|---|---|---|
| AI/ML Systems in GxP | · | AI/ML Systems × Validation × Data Governance → |
| eQMS | Change Control × Computerized System Validation → | · |
| LIMS | · | Data Integrity × Computerized System Validation → |
How to read this page
“Authored” is not one thing, so each row states what it required — a decoded standard is a different unit of work from a value-chain sector, and pretending otherwise would flatter the total. Two rows are complete by construction rather than by effort: a topic explainer and a system class cannot exist in the catalog without their prose, so those ratios could never read anything else, and they say so instead of claiming a perfect score.
Figures are counted from the catalogs at build time and reported against release v1.369.0, the same version shown in the footer. Live regulatory intelligence is a different thing measured a different way — see the live feeds, where freshness is a property of each ingest.