[ THE SPEQ FRAMEWORK ]

A Practitioner-Grade Operating Model for GxP Execution

SPEQ bridges regulatory knowledge, execution methodology, and quality systems maturity across GMP, GCP, GLP, GDP, GVP, engineering (GEP), validation, QA, QC, regulatory, manufacturing, clinical operations, lab systems, and inspection readiness.

Explore Architecture

Version 1.0July 20263 Layers · 102 Standards

[ ARCHITECTURE ]

Three layers. One integrated operating model.

Each SPEQ layer addresses a distinct practitioner challenge. Together they form a unified execution system aligned to global GxP requirements across regulated product, process, data, clinical, and laboratory environments.

SPEQ.FRAMEWORK3 LAYERS

01Regulatory Intelligence▾

02Execution Methodology▾

03Quality Systems Maturity▾

[ HOW THE LAYERS CONNECT ]

Regulatory Intelligence

Explore →

→decoded requirements

Execution Methodology

Explore →

→inspectable work

Quality Systems Maturity

Explore →

↺ The model is a closed loop, not a one-way waterfall: maturity gaps identified in Layer 03 feed back to re-prioritise regulatory focus (Layer 01) and execution effort (Layer 02).

[ LAYER DETAIL ]

What each layer contains.

Expand each layer to see the specific content, tools, and methodology included. Every item maps directly to a practitioner deliverable.

[ THE FRAMEWORK IN ACTION ]

From a single Annex 1 clause to an inspection-ready system.

The three layers are not abstract. Follow one real requirement as it moves through all three — decoded, executed, then measured.

01Regulatory Intelligence

The requirement

EU GMP Annex 1 (2022) §4 makes a documented Contamination Control Strategy (CCS) mandatory for sterile manufacturing — a holistic, risk-based view of every contamination control across the site.

EU GMP Annex 1 (2022) →

02Execution Methodology

The execution

SPEQ turns the clause into deliverable work. Assemble the required elements with the CCS Builder, then generate the inspection-ready document from the CCS template — no blank page, no missing sections.

CCS Builder tool →CCS template →

03Quality Systems Maturity

The measure

The Environmental Monitoring domain of the maturity assessment scores where your contamination control actually sits, and the rubric shows what each level looks like — so you know the next move, not just the gap.

Assess your maturity →

→ One clause, traced across all three layers. Every requirement SPEQ decodes follows the same path — that is the operating model, not a metaphor.

Read the full walkthrough →

[ DESIGN PRINCIPLES ]

Six principles that govern how the framework is built.

PRINCIPLE 01

Execution-First

Every element of the framework maps from regulatory requirement to practitioner action. Abstract guidance without implementation methodology is not SPEQ.

PRINCIPLE 02

Risk-Calibrated

ICH Q9(R1) risk principles inform all SPEQ assessment tools and template design. Risk is not an afterthought — it is the organizing principle.

PRINCIPLE 03

Inspection-Ready

Every template, checklist, and procedure is built to produce audit evidence. If it cannot be cited in a 483 response, it does not belong in SPEQ.

PRINCIPLE 04

Standards-Integrated

Cross-referenced natively to FDA, EMA, ICH, USP, and ISO. No separate mapping effort needed — the alignment is built in.

PRINCIPLE 05

Version-Controlled

All SPEQ framework documents follow semantic versioning. Practitioners always know which version of the framework they are implementing.

PRINCIPLE 06

Practitioner-Authored

Built by people who have delivered in regulated environments — not just advised on them. Every clause reflects real inspection experience.

[ STANDARDS ALIGNMENT ]

How SPEQ maps to existing industry standards.

SPEQ complements existing standards — it is the execution layer that sits on top of regulatory requirements, translating them into practitioner actions. All 102 catalog standards are placed across the three framework layers.

HAND-CURATED ALIGNMENT DEPTH17 / 102

17 standards carry a hand-curated three-layer alignment; the remaining 85are placed automatically from each standard’s primary framework layer.

Full alignment only102 shown

STANDARD / GUIDELINE	Regulatory Intelligence	Execution Methodology	Quality Systems Maturity
21 CFR Part 211GMPFDA⚠ HIGH INSPECTION RISK Current Good Manufacturing Practice for Finished Pharmaceuticals →	✓ Full	✓ Full	✓ Full
21 CFR Part 11CSVFDA⚠ HIGH INSPECTION RISK Electronic Records; Electronic Signatures →	✓ Full	✓ Full	◑ Partial
21 CFR Part 210GMPFDA Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs — General →	✓ Full	◑ Partial	—
21 CFR Part 820GMPFDA⚠ HIGH INSPECTION RISK Quality System Regulation (QSR) for Medical Devices →	◑ Partial	✓ Full	✓ Full
FDA Aseptic Processing GuidanceGMPFDA⚠ HIGH INSPECTION RISK Guidance for Industry — Sterile Drug Products Produced by Aseptic Processing →	✓ Full	◑ Partial	—
FDA Process Validation Guidance (2011)GMPFDA Guidance for Industry — Process Validation: General Principles and Practices →	◑ Partial	✓ Full	—
EU GMP Annex 1 (2022)GMPEMA⚠ HIGH INSPECTION RISK Manufacture of Sterile Medicinal Products →	✓ Full	✓ Full	◑ Partial
EU GMP Annex 11CSVEMA⚠ HIGH INSPECTION RISK Computerised Systems →	✓ Full	✓ Full	◑ Partial
EU GMP Annex 15GMPEMA Qualification and Validation →	◑ Partial	✓ Full	✓ Full
EU GMP Annex 2GMPEMA Manufacture of Biological Active Substances and Medicinal Products for Human Use →	✓ Full	◑ Partial	—
ICH Q5A(R2)GMPICH Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin →	✓ Full	◑ Partial	—
ICH Q9(R1)GMPICH Quality Risk Management →	✓ Full	✓ Full	✓ Full
ICH Q10GMPICH Pharmaceutical Quality System →	✓ Full	✓ Full	✓ Full
ICH Q8(R2)GMPICH Pharmaceutical Development →	✓ Full	◑ Partial	◑ Partial
ICH Q11GMPICH Development and Manufacture of Drug Substances (Chemical and Biotechnological/Biological Entities) →	✓ Full	◑ Partial	—
ICH Q12GMPICH Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management →	✓ Full	✓ Full	◑ Partial
ICH Q7GMPICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients →	✓ Full	◑ Partial	—
USP <1116>GMPUSP⚠ HIGH INSPECTION RISK Microbiological Control and Monitoring of Aseptic Processing Environments →	✓ Full	◑ Partial	◑ Partial
USP <1117>GMPUSP Microbiological Best Laboratory Practices →	✓ Full	◑ Partial	—
USP <1058>GMPUSP Analytical Instrument Qualification →	◑ Partial	✓ Full	—
USP <61>/<62>GMPUSP Microbiological Examination of Nonsterile Products →	✓ Full	◑ Partial	—
ISO 14644-1GMPISO Cleanrooms and Associated Controlled Environments — Classification of Air Cleanliness by Particle Concentration →	✓ Full	◑ Partial	◑ Partial
ISO 14644-2GMPISO Cleanrooms and Associated Controlled Environments — Monitoring to Provide Evidence of Cleanroom Performance →	◑ Partial	✓ Full	—
ISO 9001:2015GMPISO Quality Management Systems — Requirements →	◑ Partial	✓ Full	✓ Full
ISO 13485:2016GMPISO Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes →	◑ Partial	◑ Partial	✓ Full
ISPE GAMP 5 (2022)CSVISPE Good Practice Guide: Compliant GxP Computerised Systems →	◑ Partial	✓ Full	◑ Partial
PIC/S PE 009-16GMPPIC/S Guide to Good Manufacturing Practice for Medicinal Products →	✓ Full	✓ Full	◑ Partial
ICH E6(R3)GCPICH⚠ HIGH INSPECTION RISK Good Clinical Practice (GCP) →	✓ Full	◑ Partial	◑ Partial
ICH E8(R1)GCPICH General Considerations for Clinical Studies →	✓ Full	—	◑ Partial
21 CFR Part 312GCPFDA⚠ HIGH INSPECTION RISK Investigational New Drug Application (IND) →	✓ Full	◑ Partial	◑ Partial
21 CFR Part 50GCPFDA⚠ HIGH INSPECTION RISK Protection of Human Subjects (Informed Consent) →	✓ Full	◑ Partial	—
21 CFR Part 56GCPFDA Institutional Review Boards (IRBs) →	✓ Full	◑ Partial	—
Regulation (EU) 536/2014GCPEMA⚠ HIGH INSPECTION RISK Clinical Trials Regulation (CTR) →	✓ Full	◑ Partial	◑ Partial
21 CFR Part 58GLPFDA⚠ HIGH INSPECTION RISK Good Laboratory Practice for Nonclinical Laboratory Studies →	✓ Full	◑ Partial	◑ Partial
OECD GLP PrinciplesGLPOECD OECD Principles of Good Laboratory Practice →	✓ Full	◑ Partial	◑ Partial
Directive 2004/10/ECGLPEC Harmonisation of Laws Relating to the Application of GLP →	✓ Full	◑ Partial	—
2013/C 343/01GDPEC⚠ HIGH INSPECTION RISK EU Guidelines on Good Distribution Practice of Medicinal Products →	✓ Full	◑ Partial	—
WHO TRS 957, Annex 5GDPWHO WHO Good Distribution Practices for Pharmaceutical Products →	✓ Full	◑ Partial	—
MHRA GDPGDPMHRA UK Good Distribution Practice (Rules & Guidance for Distributors) →	✓ Full	◑ Partial	—
EU GVP ModulesGVPEMA⚠ HIGH INSPECTION RISK EU Good Pharmacovigilance Practices (GVP) →	✓ Full	—	◑ Partial
21 CFR 314.80GVPFDA⚠ HIGH INSPECTION RISK Postmarketing Reporting of Adverse Drug Experiences →	✓ Full	—	◑ Partial
ICH E2B(R3)GVPICH Electronic Transmission of Individual Case Safety Reports (ICSRs) →	✓ Full	—	◑ Partial
ICH E2AGVPICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting →	✓ Full	—	◑ Partial
MHLW Ordinance No. 179GMPPMDA Japan GMP for Drugs and Quasi-drugs →	✓ Full	◑ Partial	—
ANVISA RDC 658/2022GMPANVISA Brazilian Good Manufacturing Practices for Medicines →	✓ Full	◑ Partial	—
NOM-059-SSA1-2015GMPCOFEPRIS Mexican Good Manufacturing Practices for Medicines →	✓ Full	◑ Partial	—
ANMAT Disposición 4159/2023GMPANMAT Argentine GMP Guide for Medicines →	✓ Full	◑ Partial	—
Resolución 1160 de 2016GMPINVIMA Colombian Good Manufacturing Practices for Medicines →	✓ Full	◑ Partial	—
DS 021-2018-SAGMPDIGEMID Peruvian GMP Manual for Pharmaceutical Products →	✓ Full	◑ Partial	—
Norma Técnica N° 127GMPISP Chile Chilean Good Manufacturing Practices →	✓ Full	◑ Partial	—
China GMP (2010 Revision)GMPNMPA Good Manufacturing Practice for Drugs (China) →	✓ Full	◑ Partial	—
Revised Schedule M (2023)GMPCDSCO India GMP — Schedule M, Drugs and Cosmetics Rules →	✓ Full	◑ Partial	—
Health Canada GUI-0001GMPHealth Canada Good Manufacturing Practices Guide for Drug Products →	✓ Full	◑ Partial	—
TGA Manufacturing PrinciplesGMPTGA Australian GMP — Manufacturing Principles (PIC/S Guide) →	✓ Full	◑ Partial	—
PDA TR No. 22GMPPDA Process Simulation for Aseptically Filled Products →	◑ Partial	✓ Full	—
ICH Q3D(R2)GMPICH Guideline for Elemental Impurities →	✓ Full	◑ Partial	◑ Partial
ISO 14971:2019QMSISO Medical Devices — Application of Risk Management to Medical Devices →	◑ Partial	✓ Full	◑ Partial
ASTM E2500GEPASTM Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment →	◑ Partial	✓ Full	◑ Partial
ISPE Baseline Guide Vol. 5 (2019)GEPISPE Commissioning and Qualification (Second Edition) →	◑ Partial	✓ Full	◑ Partial
ASME BPEGEPASME Bioprocessing Equipment →	◑ Partial	✓ Full	—
MHRA GxP DI (2018)GDocPMHRA⚠ HIGH INSPECTION RISK MHRA 'GxP' Data Integrity Guidance and Definitions →	✓ Full	◑ Partial	◑ Partial
PIC/S PI 041-1GDocPPIC/S⚠ HIGH INSPECTION RISK Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments →	✓ Full	◑ Partial	◑ Partial
WHO GCLP (2009)GCLPWHO Good Clinical Laboratory Practice (GCLP) →	✓ Full	◑ Partial	—
21 CFR Part 117GMPFDA⚠ HIGH INSPECTION RISK Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food →	✓ Full	◑ Partial	—
21 CFR Part 111GMPFDA⚠ HIGH INSPECTION RISK Current Good Manufacturing Practice for Dietary Supplements →	✓ Full	◑ Partial	—
Codex CXC 1-1969GMPCodex General Principles of Food Hygiene →	✓ Full	◑ Partial	—
ISO 22000:2018QMSISO Food safety management systems — Requirements for any organization in the food chain →	◑ Partial	◑ Partial	✓ Full
21 CFR Part 226GMPFDA Current Good Manufacturing Practice for Type A Medicated Articles →	✓ Full	◑ Partial	—
21 CFR Part 225GMPFDA Current Good Manufacturing Practice for Medicated Feeds →	✓ Full	◑ Partial	—
VICH GL9GCPVICH Good Clinical Practice (Veterinary) →	✓ Full	◑ Partial	—
Regulation (EU) 2019/6GMPEC Veterinary Medicinal Products →	✓ Full	◑ Partial	◑ Partial
ISO 22716:2007GMPISO Cosmetics — Good Manufacturing Practices (GMP): Guidelines on Good Manufacturing Practices →	✓ Full	◑ Partial	—
21 CFR Part 1271GMPFDA Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) →	✓ Full	◑ Partial	—
21 CFR Part 606GMPFDA Current Good Manufacturing Practice for Blood and Blood Components →	✓ Full	◑ Partial	—
Regulation (EU) 2017/745QMSEC⚠ HIGH INSPECTION RISK Medical Device Regulation (MDR) →	✓ Full	◑ Partial	◑ Partial
21 CFR Part 803GVPFDA⚠ HIGH INSPECTION RISK Medical Device Reporting (MDR) →	✓ Full	◑ Partial	◑ Partial
IEC 62304:2006+A1:2015CSVIEC Medical Device Software — Software Life Cycle Processes →	✓ Full	◑ Partial	◑ Partial
IEC 60601-1GEPIEC Medical Electrical Equipment — General Requirements for Basic Safety and Essential Performance →	✓ Full	◑ Partial	◑ Partial
21 CFR Part 1, Subpart LGDPFDA Foreign Supplier Verification Programs (FSVP) →	✓ Full	◑ Partial	◑ Partial
21 CFR Part 121GMPFDA Mitigation Strategies to Protect Food Against Intentional Adulteration →	✓ Full	◑ Partial	◑ Partial
21 CFR Part 507GMPFDA Current Good Manufacturing Practice and Preventive Controls for Food for Animals →	✓ Full	◑ Partial	◑ Partial
VICH GL3(R)GMPVICH Stability Testing of New Veterinary Drug Substances and Medicinal Products →	✓ Full	◑ Partial	—
MoCRA (FD&C Act Ch. VI)QMSFDA Modernization of Cosmetics Regulation Act of 2022 →	✓ Full	◑ Partial	◑ Partial
Regulation (EC) No 1223/2009QMSEC EU Cosmetic Products Regulation →	✓ Full	◑ Partial	◑ Partial
21 CFR Part 700GMPFDA Cosmetics — General →	✓ Full	◑ Partial	—
FD&C Act §503AGMPFDA⚠ HIGH INSPECTION RISK Pharmacy Compounding — Conditions for Exemption →	✓ Full	◑ Partial	◑ Partial
FD&C Act §503BGMPFDA⚠ HIGH INSPECTION RISK Outsourcing Facilities — Registration and cGMP →	✓ Full	◑ Partial	—
USP <795>GMPUSP⚠ HIGH INSPECTION RISK Pharmaceutical Compounding — Nonsterile Preparations →	✓ Full	◑ Partial	◑ Partial
USP <797>GMPUSP⚠ HIGH INSPECTION RISK Pharmaceutical Compounding — Sterile Preparations →	✓ Full	◑ Partial	—
USP <800>GMPUSP⚠ HIGH INSPECTION RISK Hazardous Drugs — Handling in Healthcare Settings →	✓ Full	◑ Partial	◑ Partial
State Pharmacy Practice ActsGMPState Boards of Pharmacy⚠ HIGH INSPECTION RISK State Pharmacy Practice Acts and Compounding Regulations →	✓ Full	◑ Partial	◑ Partial
21 CFR Part 1301GMPDEA Registration of Manufacturers, Distributors and Dispensers of Controlled Substances →	✓ Full	◑ Partial	◑ Partial
21 CFR Part 1304GDocPDEA Records and Reports of Registrants →	✓ Full	◑ Partial	◑ Partial
Ph. Eur.GMPEDQM⚠ HIGH INSPECTION RISK European Pharmacopoeia →	✓ Full	◑ Partial	—
CEP (EDQM Certification)GMPEDQM Certificate of Suitability to the Monographs of the European Pharmacopoeia →	✓ Full	◑ Partial	—
IMDRF/SaMD WG/N10CSVIMDRF Software as a Medical Device (SaMD): Key Definitions →	✓ Full	◑ Partial	◑ Partial
IMDRF/SaMD WG/N12CSVIMDRF SaMD: Possible Framework for Risk Categorization and Corresponding Considerations →	✓ Full	◑ Partial	◑ Partial
IPEC-PQG GMP Guide (v5, 2022)GMPIPEC⚠ HIGH INSPECTION RISK Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients →	◑ Partial	✓ Full	◑ Partial
ISO/IEC 17025:2017GLPISO General requirements for the competence of testing and calibration laboratories →	✓ Full	◑ Partial	◑ Partial
ILAC MRAGLPILAC ILAC Mutual Recognition Arrangement →	✓ Full	◑ Partial	—
DSCSA (FD&C Act §§581–585)GDPFDA⚠ HIGH INSPECTION RISK Drug Supply Chain Security Act →	✓ Full	◑ Partial	◑ Partial
GS1 General SpecificationsGDPGS1 GS1 General Specifications — identification keys, data attributes and barcodes →	◑ Partial	✓ Full	—

✓ FullNative alignment — no additional mapping required

◑ PartialCovers key clauses — supplemental mapping may be needed

—Out of scope for this layer

All 102 standards placed across the three layers · 17 hand-curated, 85 derived from each standard’s primary framework layer · Browse the full catalog →

[ THE FRAMEWORK ACROSS THE HUB ]

One framework. Every resource, mapped.

Each layer connects to the working resources behind it — jump straight from the model to the standards, tools, templates, and assessment that operationalise it.

Regulatory Intelligence

The decoded regulatory sources you are cited against.

Standards Library102 standards→Global Regulators37 bodies→

Execution Methodology

How requirements convert into delivered, inspectable work.

Interactive Tools16 tools→Template Library28 templates→Software Directory29 platforms→

Quality Systems Maturity

Where your quality system sits today, and the path forward.

Maturity Model5 levels→Assessment~10 min→FDA QMM5 areas→Quality EconomicsROI→

[ COVERAGE BY DISCIPLINE ]

GMPGood Manufacturing Practice60 GCPGood Clinical Practice7 GLPGood Laboratory Practice5 GDPGood Distribution Practice6 GVPGood Pharmacovigilance Practice5 GEPGood Engineering Practice4 GDocPGood Documentation Practice3 GCLPGood Clinical Laboratory Practice1 CSVComputerised System Validation6 QMSQuality Management Systems5

[ ACROSS THE VALUE CHAIN ]

The same framework serves every organization in the regulated value chain — what you make, and who you are within it.

CDMOs & Contract Manufacturers CROs & Contract Research Contract Testing Laboratories Distribution & Logistics Compounding Pharmacies Excipient & Raw-Material Suppliers Sponsors & Marketing Authorization Holders Packaging, Labeling & Serialization Notified Bodies & Certification Software & Equipment Vendors Clinical Trial Sites

[ HOW TO USE THE FRAMEWORK ]

Three steps to operationalise SPEQ.

Assess

Run the SPEQ Maturity Assessment to baseline your quality system across five foundational domains — or all twelve in the Comprehensive assessment. Identify your current level and priority gaps.

Start Assessment →

Apply

Map regulatory requirements to the execution methodology for your product type and manufacturing environment.

View Standards →

Improve

Use gap analysis outputs to build your remediation roadmap. Download templates and tools to accelerate execution.

Browse Templates →

[ START HERE ]

Put the framework to work — no download required.

Baseline your maturity

Run the assessment across the GxP quality domains and get an instant scored result.

Start assessment →

Browse the standards

Search the decoded standards library, filterable by discipline and regulatory body.

Open library →

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