Regulations change.
355 rule changes, guidances, safety alerts, recalls and non-compliance reports were published in the last 90 days across FDA, EMA, MHRA, Health Canada and the EU GMP inspectorate. Most will never touch you. Some already have.
Every GxP discipline
LIVE · 11 REGULATORY SOURCES · LAST INGEST 29 JUL 2026
Regulations change. Your evidence has to change with them.
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
Start with the requirement.
One search across every standard, regulator, tool, and template SPEQ decodes.
SEARCHES 102 STANDARDS · 35 REGULATORS · 28 TEMPLATES · 16 TOOLS — PRESS / TO FOCUS
What moved — last 7 days
89FDA enforcement actions
8Warning letters issued
26Guidance & rule changes
32Rules open for comment now
Every figure pulled live from primary sources. Machine-detected, human-reviewed, source-linked. Open the full feed →
THE EXECUTION GAP
The gap isn’t just between guidance and practice. It moves.
Your evidence doesn't.
The SOP was written against the 2003 Annex. The validation package predates the current data-integrity expectations. Nothing failed — the ground moved, and the paperwork stayed where it was.
Nobody tells you which is which.
Regulators publish. They do not map their publications onto your disciplines, your sites, or your quality agreements. That mapping is the work, and it is done by hand, by people who already have jobs.
SPEQ does that mapping continuously — and shows its working.
THE LOOP
Detect. Interpret. Close. Repeat.
- 01
Detect
11 regulatory ingests run on a fixed schedule — most daily, the fastest every six hours. Content hashing flags what actually changed against the previous snapshot, not what was merely republished.
- 02
Review
Every detected change enters a review queue with its source URL, fetch timestamp, and confidence. Nothing reaches the site unread. The record and our reading of it stay separate.
- 03
Interpret
An approved change is mapped against 102 decoded standards, 10 disciplines, 11 value-chain sectors, and 12 maturity domains — so the answer to "does this touch me" is structural, not a guess.
- 04
Close
Each mapped change points to the instrument that produces the evidence: a calculator, a gap assessment, a template, an assessment domain.
- 05
Re-baseline
Closing a gap moves your maturity score. The new baseline re-prioritises what to watch next.
THE SOURCE MAP
Built on the sources you are cited against.
Every standard SPEQ decodes traces to a named regulator, harmonizer, or compendium. Select any body to see what SPEQ maps from it.
↳ Explore all regulatory bodiesTHE SPEQ FRAMEWORK
One core. Three strata. Logged top to bottom.
The layers are not a diagram — they are a continuous sample. SPEQ reads the whole column: the regulation, the methodology that delivers it, and the maturity that measures the result.
Regulatory Intelligence
Decoded sources practitioners are cited against across GMP, GCP, GLP, validation, data integrity, and quality systems.
↳ Explore the Full FrameworkExecution Methodology
How regulatory requirements convert into delivered, audit-ready work.
↳ Explore project deliveryQuality Systems Maturity
Where your quality system sits today — and the roadmap to where it must go.
↳ Assess your maturityWHO THIS IS FOR
GxP is not one job, and it is not one company.
The sponsor holds the authorisation. The CDMO runs the process. The lab does the testing. The distributor holds the cold chain. The obligation is shared and the accountability is not transferable — but the tooling has always been built for one party and sold to the largest one.
SPEQ is built across the chain. The same Annex 1 clause is traced differently for the site that operates the cleanroom and the sponsor that has to oversee it.
BY ROLE IN THE CHAIN
CDMOs & Contract ManufacturersCROs & Contract ResearchContract Testing LaboratoriesDistribution & LogisticsCompounding PharmaciesExcipient & Raw-Material SuppliersSponsors & Marketing Authorization HoldersPackaging, Labeling & SerializationNotified Bodies & CertificationSoftware & Equipment VendorsClinical Trial Sites
THE CORPUS
The record underneath it.
Interpretation is only worth something if the source is exact. Every mapping above resolves to this.
102standards decoded
35regulators with a decoded page
10GxP disciplines
11value-chain sectors
6industries
12maturity domains
16interactive tools
28document templates
29software platforms mapped
16topic explainers
Every standard is quoted from its primary source, never paraphrased into inaccuracy. Every page keeps the requirement and SPEQ’s reading of it separate.
THE HUB, MAPPED
Everything SPEQ holds, in one picture.
Six pillars, one cross-linked hub. Every count below is live from the catalog — pick any door in.
SPEQSPEQ — the specification of quality.
REGULATORY INTELLIGENCE
Intelligence that closes the execution gap.
LIVE · openFDA
FDA Enforcement Signals
Every recall is a quality signal. Live FDA drug and device recalls, mapped to the GxP quality domains SPEQ assesses.
Open the explorer →REGULATOR-ENDORSEDFDA QMM Readiness
FDA now rates quality management maturity beyond CGMP. See the five practice areas — and where your quality system would stand.
Understand QMM →FORWARD LOOKINGGxP Horizon
What’s changing and when — verified effective and transition dates, open comment windows, and the themes reshaping practice.
See what’s ahead →FROM THE LIBRARY
Templates and tools practitioners reach for daily.
TEMPLATESOP
01
SOP Development Template
Standardized SOP format with all required GMP elements: purpose, scope, responsibilities, definitions, procedure, related documents, and revision history. Built to 21 CFR 211.100 (written procedures).
21 CFR Part 211 · v4.1Open →TEMPLATERISK ASSESSMENT
02
Quality Risk Assessment (QRA) — Type 1
Standard QRA template for process and change control risk assessment using FMEA methodology. Maps directly to ICH Q9(R1) formality guidance.
ICH Q9(R1) · v3.0Open →TEMPLATEREPORT
03
Annual Product Review (APR) Framework
Structured APR/Annual Product Quality Review template aligned to ICH Q10 lifecycle management requirements. Includes data trending sections and CAPA integration fields.
ICH Q10 · v1.3Open →TOOLINTERACTIVE
04
Quality Systems Maturity Assessment
Baseline your quality system in ten minutes
Radar chart + Gap report · ~10 minOpen →TOOLINTERACTIVE
05
ICH Q9 Risk Priority Calculator
FMEA-based risk scoring with export
RPN table + Rationale · ~45 minOpen →TOOLINTERACTIVE
06
EM Alert & Action Level Calculator
USP <1116>-based limit setting
Alert/action level table · ~15 minOpen →QUALITY SYSTEMS MATURITY
Where does your quality system stand?
Baseline your maturity across 12 GxP domains — a Quick Scan in minutes, or the comprehensive assessment with a printable roadmap and FDA QMM readiness rollup.
Start with what moved this week.
The standards, trackers and calculators are open and stay open — no account, no gate.