SPEQ watches what regulators actually publish — enforcement, guidance, alerts, rule changes — across every GxP discipline, and tells you which of it lands in your scope and what closes it.
GMP, GCP, GLP, GDP, GVP, validation, data integrity. Sponsors, CDMOs, CROs, labs, distributors. One decoded record of what the regulators require, one set of instruments that produce the evidence, and a continuous check on the distance between them.
SEARCH THE RECORD · I KNOW WHAT I NEED
One search across every standard, regulator, tool, and template SPEQ decodes.
SEARCHES 214 STANDARDS · 48 REGULATORS · 112 TEMPLATES · 36 TOOLS — PRESS / TO FOCUS
[ THE INFORMATION PRODUCT ]
What SPEQ holds, what you can do with it today, and the direction it is being built toward — kept apart, so the third never reads as a promise about the first two.
01 · THE RECORD
What SPEQ contains today.
Primary-source standards, regulators, guidance, enforcement activity, topics, and structured reference information — decoded, versioned, and linked back to the document it came from.
02 · THE INTELLIGENCE PRODUCT
What you can do with it now.
What changed, what it means, who or what may be affected, and which evidence or action may be relevant — with the requirement and the interpretation kept visibly apart.
03 · THE OPERATIONS FABRIC
What it is becoming.
The larger connection among requirements, controls, systems, facilities, roles, evidence, decisions, and outcomes. This layer is design direction, not an availability claim.
DESIGN DIRECTION · NOT AN AVAILABILITY CLAIM
[ THE INTELLIGENCE SPECIMEN ]
PROVENANCE
No human review is claimed for this record. Assurance here is machine publication assurance: the checks named above ran and passed.
[ ONE OBJECT, MANY RENDERINGS ]
These are not eight products. Each is a rendering of the same governed object, so they never disagree with each other — and a correction to the record propagates to all of them.
Search
A ranked answer carrying the requirement extract and its source status, not a page of blue links.
Intelligence
What changed, against which version, and what class of change it is.
Topics
Plain-language context for the practitioner who needs the concept, not the clause.
Briefing
The week’s changes grouped by authority and effective horizon.
Maturity model
Which maturity domain the change touches, and what is worth assessing.
Templates
The instrument that helps produce the evidence the requirement expects.
Listen
The same record read aloud, for the commute and the shop floor.
Enterprise
Candidate impact across authorised sites, systems, and controls. Enterprise direction.
Every view above is derived from the record, not authored separately from it. A correction propagates to all of them, and they never disagree with each other.
[ QUALITY MATURITY ]
Regulatory change only matters if you can respond to it. Maturity is the measure of whether you can — and it is answered domain by domain, with evidence, not by an overall impression.
ASK YOURSELF FIRST
ONE REAL QUICK SCAN QUESTION · DOCUMENTATION & CHANGE CONTROL
DIRECTIONAL READING FROM ONE ANSWER · NOT AN ASSESSED LEVEL
CAPABILITY PLACEMENT
Level 3 · Managed
Structured, proactive, inspection-ready.
SUPPORTING EVIDENCE
A formal change record carrying cross-functional review and a regulatory impact assessment, retrievable by change number without a search party.
CONNECTED CONSEQUENCES
This is the level most sites plateau at. Advancing unlocks Risk Management & CAPA and Regulatory Intelligence, neither of which reaches level 4 while impact assessment stays judgement-based.
IMPROVEMENT SEQUENCE
RE-BASELINE
A level 3 from January may not be a level 3 today. The Annex 1 restructure in the record above changes what a contamination control strategy has to demonstrate — and every domain that reads from that record moves with it. See the record that moved →
[ THE LANDSCAPE SHEET ]
An overall level hides where the work is. The sheet shows each domain’s assessed level, the target it is being held to, whether the evidence exists, and how the risk ranks — sample data, shown to demonstrate the shape of the output.
| DOMAIN | TIER | LEVEL 1–5 | EVIDENCE | RISK RANK |
|---|---|---|---|---|
| Documentation & Change Control | QUICK SCAN | 3 → 4 | CURRENT | MEDIUM |
| Risk Management & CAPA | QUICK SCAN | 2 → 3 | PARTIAL | HIGH |
| Validation & Qualification | QUICK SCAN | 3 → 4 | CURRENT | MEDIUM |
| Environmental Monitoring | QUICK SCAN | 3 → 3 | CURRENT | LOW |
| Regulatory Intelligence | QUICK SCAN | 2 → 4 | NONE | HIGH |
| Clinical Quality (GCP) | COMPREHENSIVE | 3 → 3 | PARTIAL | LOW |
| Nonclinical & Laboratory (GLP) | COMPREHENSIVE | 2 → 3 | PARTIAL | MEDIUM |
| Distribution & Cold Chain (GDP) | COMPREHENSIVE | 3 → 3 | CURRENT | LOW |
| Pharmacovigilance (GVP) | COMPREHENSIVE | 2 → 3 | PARTIAL | MEDIUM |
| Data Integrity | COMPREHENSIVE | 2 → 4 | NONE | HIGH |
| Engineering & Commissioning (GEP) | COMPREHENSIVE | 3 → 3 | PARTIAL | LOW |
| Quality Culture & Empowerment | COMPREHENSIVE | 2 → 3 | NONE | MEDIUM |
IMPROVEMENT QUEUE · RANKED BY DEPENDENCY
Not the lowest scores — the ones that unlock the most. A domain that three others read from is worth more than a domain that sits on its own.
ASSESSED AGAINST TARGET
[ THE LOOP, AND WHO READS IT ]
The last link is drawn open because it is the one most often left undone. A baseline that is never re-taken measures the day it was taken, not the system.
FOR THE PEOPLE WHO FUND THE WORK
Categories, not figures. SPEQ does not publish savings numbers it cannot defend with customer data.
EXPLORER · FREE
A directional baseline, in about four minutes.
PROFESSIONAL
14-DAY TRIALTurn the baseline into an improvement roadmap.
TEAM
5-SEAT MINIMUMShared ownership of one baseline.
ENTERPRISE
QUALIFIED FIRSTCompare, benchmark, and watch capability move.
SPEQ's maturity levels are a SPEQ synthesis. No regulatory endorsement of any maturity level is implied or offered.
[ EIGHT WAYS IN ]
The taxonomy is a graph, not eight separate indexes. Whichever axis you enter on, you reach the same record — which is why each one shows where it crosses into the others.
BROWSE BY STANDARD — 214 STANDARDS DECODED TO THE REQUIREMENT
WHERE “EU GMP Annex 1” CROSSES INTO OTHER AXES
Same record, three different doors. That is what makes this a taxonomy rather than eight lists that happen to sit beside each other.