See citation patterns
Compare CFR citation rates per 100 inspections, by year and quality system, with counts, denominators and data limits visible.
[ SPEQ · FOR REGULATED LIFE SCIENCES ]
Your workspace for GxP practice.
Understand requirements, monitor regulatory activity, and put guidance into practice. Start with free standards, tools and learning resources.
Now launching: SPEQ Intelligence. Investigate FDA inspections, released Form 483s, warning letters and recalls, with citation trends, readiness briefs and Ask SPEQ.
01 · EXPLORER · FREE
Explore requirements. Find your starting point.
SEARCH THE RECORD · I KNOW WHAT I NEED
Start with the requirement.
One search across every standard, regulator, tool, and template SPEQ decodes.
SEARCHES 224 STANDARDS · 54 REGULATORS · 122 TEMPLATES · 36 TOOLS — PRESS / TO FOCUS
Founding a company around a discovery? The startup regulatory journey →
[ FREE MATURITY BASELINE ]
Can your quality system keep pace?
Try one real Quick Scan question. A single answer gives a directional reading, not an assessed maturity level.
DIRECTIONAL READING FROM ONE ANSWER · NOT AN ASSESSED LEVEL
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.
What to consider next — evidence, dependencies and reassessment
Ask yourself first
Improvement sequence
[ THE LANDSCAPE SHEET ]
12 domains, assessed against target.
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.
- 01REGULATORY INTELLIGENCEStand up a monitored source list and route change to a named assessor.UNLOCKS 3 DOMAINS
- 02DATA INTEGRITYDefine the audit-trail review that the other eleven domains rely on for evidence.UNLOCKS 4 DOMAINS
- 03RISK MANAGEMENT & CAPAMake effectiveness check a gate, not a field.UNLOCKS 2 DOMAINS
ASSESSED AGAINST TARGET
How assessment supports improvement →
02 · PROFESSIONAL · $79 / MONTH
Monitor regulatory activity. Put requirements into practice.
Track the sources that matter to your work. Use implementation guides, editable templates and a sequenced remediation roadmap to act on what you find.
- Monitor Unlimited watchlists and Professional analyses.
- Implement Guides, playbooks, editable templates and analysis PDFs.
- Prioritize A remediation roadmap from your free maturity assessment.
03 · INTELLIGENCE · $299 / MONTH
Go beyond the registers. See patterns and prepare.
[ THE INTELLIGENCE UPGRADE ]
From individual records to inspection preparation.
Professional includes access to the FDA registers. Intelligence adds the full investigation workspace, peer analysis, readiness briefs and Ask SPEQ. Available published records are linked by establishment; missing records and uncertain matches remain visible.
Prepare with a readiness brief
Review what FDA cited at establishments in your selected peer cohort and assign an owner to preparation gaps.
Ask SPEQ, follow the sources
Ask a question across the catalog and FDA records. Inspect the standards, clauses and records cited in the answer.
Follow what matters
Follow firms, CFR sections or people and receive matched-record email alerts when something changes.
RECORDS INGESTED BY SPEQ IN THE LAST 7 DAYS: 10 WARNING LETTERS · 71 ENFORCEMENT ACTIONS
[ REAL INTERFACE · FOUR EXAMPLES ]
See SPEQ Intelligence at work
See citation trends, inspect the underlying firm and 483 records, then review a readiness brief. Professional includes the registers; Intelligence adds the analysis and preparation views shown here.
Real SPEQ interface · Invented firms and demonstration records. This is a recorded preview, not a live session.
SPEQ INTELLIGENCE · EXAMPLE 1 OF 6
Start from a citation pattern
How often §211.113(b) was cited per 100 drug inspections, with closed years and small-number limits in view. Then open the inspections behind the number.
[ PLANS ]
Start free. Pay when it earns its place.
PROFESSIONAL
$79/ month
Continuous regulatory intelligence — and the toolkit to act on it.
Choose Professional →INTELLIGENCE
$299/ month
Everything in Professional, plus Ask SPEQ and the full SPEQ Intelligence app.
Choose Intelligence →Every available plan and its limits: see pricing.
Built by Isaiah Castellanos, a quality and validation practitioner across pharmaceutical, biotech, device and laboratory environments. Why SPEQ exists →