Brochures, readiness guides and inspection-ready checklists.
18 industry brochures and 58 clause-by-clause readiness guides — everything QA, compliance and operations leaders need to walk into an inspection with a straight back.
One PDF per sector. International standards covered.
Print, share with your team, or send to your inspectors and customers. Every brochure leads with the regulations that apply in your industry — FDA, EU, BRCGS, SQF, ISO and more.
Medical Devices
Class I/II/III device manufacturers — eDHR, UDI, design controls.
Pharmaceutical
Drug manufacturers, compounders, OTC — full cGMP batch records.
Dietary Supplements
Vitamins, sports nutrition, nutraceuticals — 21 CFR 111 ready.
Food Processing
FSMA 204, HACCP, GFSI — preventive controls and traceability lots.
Bakery & Confectionery
Allergen control, label accuracy, sanitation cycles — without paper.
Sausage & Meat Products
USDA FSIS HACCP, lethality logs, label approval — production-grade.
Cosmetics & Personal Care
MoCRA registration, GMP, adverse event records — by construction.
Consumer Products
CPSC compliance, Prop 65, retailer chargebacks — controlled production.
Ingredients & Dry Mixes
B2B blends, custom formulas, customer COAs — release to spec, every time.
Plastics & Resins
Compounders & molders — recipe control, regrind tracking, customer specs.
Agricultural Chemicals
EPA registration, FIFRA labeling, batch identity for crop protection.
Radiopharmaceuticals
PET, SPECT, alpha & beta therapy — decay-corrected batch records & conditional release.
Cannabis & Hemp Manufacturing
Edibles, vapes, tinctures — state-GMP, METRC traceability, COA-per-batch.
Pet Food & Pet Supplements
Kibble, treats, supplements — FSMA + AAFCO + nutrient guarantee.
Veterinary Pharmaceuticals
Animal drugs — 21 CFR 211 + FDA CVM, with cold-chain and Annex 11 e-sigs.
Specialty & Industrial Chemicals
Coatings, adhesives, reagents — REACH, TSCA, OSHA PSM, GHS / SDS per lot.
Blood & Tissue
Blood centers, tissue banks, birth tissue — 21 CFR 1271 / 606, AABB, AATB.
58 plain-English guides to the regulations that actually matter.
Each one ends with the evidence inspectors ask for and a 60–90 day path to get there.
21 CFR 211 Drug cGMP
Plain-English guide to 21 CFR Part 211 — current Good Manufacturing Practice for finished pharmaceuticals. Subparts B through K, data integrity, ALCOA+, and an FDA inspection-ready path.
21 CFR Part 11
Plain-English guide to FDA 21 CFR Part 11 — electronic records, electronic signatures, audit trails, and a practical path to a Part 11-compliant eQMS without theatre.
FDA 510(k) Clearance
Plain-English readiness guide for FDA 510(k) Premarket Notification — predicate selection, eSTAR submission, RTA pre-check, MDUFA V timelines, AI-NAI hold cycles, and the path to a clean substantial-equivalence decision.
AABB Blood Bank Standards
Readiness guide for blood banks and transfusion services against the AABB Standards for Blood Banks and Transfusion Services (33rd ed.) and 21 CFR 600/606/610.
AI/ML Medical Device Readiness: FDA PCCP + EU AI Act, In One Plan
Practical readiness guide for AI/ML-enabled medical devices — FDA's December 2024 PCCP final guidance, the EU AI Act layered on top of MDR/IVDR, and a unified QMS plan that satisfies both.
BRCGS Food Safety Issue 9
Plain-English guide to BRCGS Global Standard for Food Safety Issue 9 — fundamentals, HACCP, food safety culture, unannounced audits, and a path to AA grade.
US Cannabis State GMP
Readiness guide for licensed cannabis cultivators, manufacturers and processors — state GMP rules (FOCUS, ASTM, AHPA), seed-to-sale, testing, recall and inspection.
Cannabis Traceability & Recall
Practical guide to cannabis traceability and recall — METRC and equivalent systems, ASTM D8434 safety standards, state recall rules, complaint handling and adverse event reporting.
DSCSA
Plain-English guide to the Drug Supply Chain Security Act (DSCSA) — serialization, aggregation, EPCIS exchange, verification, and the path through enhanced drug distribution security.
Electronic Batch Record (EBR) System
Plain-English readiness guide for electronic batch records — 21 CFR Part 11 / EU GMP Annex 11 compliance, MBR vs EBR, review-by-exception, exception management, and the path off paper.
EPA FIFRA Pesticide Manufacturing
Readiness guide for pesticide registrants and producers under FIFRA — Section 3 registration, establishment registration (Section 7), Section 6 reporting, label compliance and EPA inspections.
EU 10/2011 Plastics Food-Contact
Readiness guide for plastic food-contact materials under Commission Regulation (EU) 10/2011 — Union List, SML, OML, NIAS, declaration of compliance and supporting documentation.
EU AI Act
Plain-English guide to Regulation (EU) 2024/1689 — the EU AI Act — for pharmaceutical, medical-device and regulated manufacturers. Risk tiers, high-risk AI systems, GMLP, predetermined change control, and how the AI Act stacks on top of GMP, 21 CFR Part 11, Annex 11, GAMP 5 and CSA.
EU Cosmetics Regulation 1223/2009
Plain-English readiness guide to EU Regulation (EC) 1223/2009 — Responsible Person, PIF, CPNP notification, safety assessment, labelling and post-market surveillance.
EU Falsified Medicines Directive
Plain-English guide to the EU Falsified Medicines Directive 2011/62/EU and Delegated Regulation 2016/161 — unique identifier, tamper-evident features, EMVS connection and the path to clean dispense-time verification.
EU GDP
Plain-English guide to EU Good Distribution Practice (2013/C 343/01) — Responsible Person duties, temperature control, qualifications, falsified medicines, and inspection.
EU GMP Annex 1 Sterile Manufacturing
Plain-English guide to the 2022 revision of EU GMP Annex 1 — sterile medicinal products. Contamination Control Strategy, QRM, grade A/B/C/D, barrier technology and aseptic process simulation.
EU GMP Annex 11
A practical, audit-ready walkthrough of EU GMP Annex 11 — what each clause means, what inspectors look for, and how to evidence compliance for any GxP system.
EU GMP for Medicinal Cannabis
EU GMP readiness for medicinal cannabis cultivators, extractors and finished-product manufacturers — Part I, Annex 7 (herbal), Annex 1 (sterile), QP release and EU-GMP certification.
EU IVDR
Plain-English guide to Regulation (EU) 2017/746 — the In Vitro Diagnostic Regulation. Risk classes, performance evaluation, notified body involvement, and a path through the transition deadlines.
EU MDR Technical Documentation
Plain-English guide to EU MDR technical documentation — Annex II device file, Annex III post-market surveillance, GSPR, clinical evaluation, and notified-body review.
EU REACH for Agrochemicals
How REACH (EC) 1907/2006 interacts with EU pesticide regulation 1107/2009 — registration boundary, SVHC, authorisation, restrictions and supply-chain documentation for agrochemical manufacturers.
EU Tissues & Cells Directive 2004/23/EC
Readiness guide for EU tissue and cell establishments — Directive 2004/23/EC, implementing Directives 2006/17 and 2006/86, the SoHO Regulation transition and competent authority inspection.
FDA 21 CFR 1271 HCT/P
Readiness guide for human cells, tissues, and cellular and tissue-based products under 21 CFR Part 1271 — registration, donor eligibility, CGTP, adverse reaction reporting and 361 vs 351 boundary.
FDA 21 CFR 177 Food-Contact Polymers
Readiness guide for plastics and resin manufacturers supplying food-contact polymers under 21 CFR 177 — clearance routes, FCN, threshold of regulation, extractables and migration testing.
FDA QMSR Transition Guide: 21 CFR 820 to ISO 13485
Plain-English guide to FDA's Quality Management System Regulation (QMSR) — what changes from 21 CFR 820, what 13485 brings in, and how to transition by 2 February 2026.
FSMA 204 Food Traceability
Plain-English guide to FDA FSMA Section 204 — the Food Traceability List, Key Data Elements, Critical Tracking Events, and how to be 24-hour-ready before the January 2026 deadline.
FSMA Preventive Controls & PCQI
Plain-English guide to FSMA Preventive Controls for Human Food (21 CFR 117) — the food safety plan, hazard analysis, PCQI duties, and a realistic readiness path.
FSSC 22000
Plain-English guide to FSSC 22000 v6 — ISO 22000, sector PRPs, and the additional FSSC requirements that auditors actually focus on during certification.
FSVP
Plain-English guide to FDA's Foreign Supplier Verification Program — hazard analysis, supplier evaluation, verification activities, and the records FDA actually inspects.
GAMP 5 & FDA CSA
Plain-English guide to GAMP 5 second edition and FDA's Computer Software Assurance — software categories, risk-based testing, intended use, and a leaner validation pack.
GLP 40 CFR Part 160
Plain-English guide to EPA Good Laboratory Practice (40 CFR Part 160) for pesticide studies — Study Director, QA Unit, raw data, archival and inspection readiness.
GMP Manufacturing
Plain-English readiness guide for GMP manufacturing — what cGMP requires today across drugs, devices, supplements and food, the operational spine inspectors look for, and a 90-day path from gap analysis to inspection-ready.
HACCP Codex
Plain-English guide to HACCP per Codex Alimentarius CXC 1-1969 Rev.5 (2020) — the seven principles, the twelve logic steps, prerequisite programmes and a plan that survives any GFSI audit.
ICH E6(R3) Good Clinical Practice
Plain-English guide to ICH E6(R3) — the 2025 revision of Good Clinical Practice. Quality by design, fit-for-purpose, risk-proportionate oversight, sponsor and investigator duties, computerised systems Annex 2, and a defensible GCP programme for FDA, EMA, MHRA, PMDA and Health Canada inspections.
ICH Q10 Pharmaceutical Quality System
Plain-English guide to ICH Q10 — the global Pharmaceutical Quality System. Management responsibilities, lifecycle stages, enablers, and a practical implementation path.
ICH Q7 API GMP
Plain-English guide to ICH Q7 — Good Manufacturing Practice for Active Pharmaceutical Ingredients. Process step boundaries, the API starting material, change control and the FDA/EMA expectations.
ICH Q8, Q11 & Q12
Plain-English guide to ICH Q8(R2), Q11 and Q12 — Quality by Design, design space, control strategy, Established Conditions and Post-Approval Change Management Protocols (PACMPs). Built for QA, regulatory affairs and process development leads at pharma and biotech.
ICH Q9(R1) Quality Risk Management
Plain-English guide to ICH Q9(R1) — the international standard for Quality Risk Management in pharmaceuticals. Subjectivity, formality, hazard ID, and a QRM programme inspectors trust.
IEC 62304 Medical Device Software
Plain-English guide to IEC 62304 — the lifecycle standard for medical device software. Safety classes, SOUP, problem resolution, and a software file that survives audit.
IFS Food Version 8
Plain-English guide to IFS Food Version 8 — the GFSI-recognised standard used across European retail. KO requirements, scoring, unannounced audits and a path to a Higher Level certificate.
IQ OQ PQ Process Validation
Plain-English guide to Installation, Operational, and Performance Qualification under FDA process validation guidance, EU GMP Annex 15, and ICH Q8/Q9/Q10. Stage-2 PPQ, statistical sampling, and continued process verification.
ISO 13485
Plain-English guide to ISO 13485:2016 — the QMS standard for medical devices. Scope, process approach, risk, design controls, and a realistic certification path.
ISO 14971 Risk Management
Plain-English guide to ISO 14971:2019 — the risk management standard for medical devices. Hazards, harms, risk control, residual risk, and a living risk management file.
ISO 17034
Plain-English guide to ISO 17034:2016 — the international standard for the competence of reference material producers. CRM characterization, homogeneity, stability, metrological traceability, commutability, value assignment, uncertainty budgets and a path to accreditation.
ISO 22000:2018 Food Safety Management
Plain-English guide to ISO 22000:2018 — the international food safety management standard. PDCA, HACCP, PRPs, the operational PRP concept and a path to a clean certification audit.
ISO 22716 Cosmetics GMP
Plain-English guide to ISO 22716 — Good Manufacturing Practices for cosmetics. EU Regulation 1223/2009 link, premises, production, laboratory, internal audits and the path to a clean inspection.
ISO 9001:2015
Plain-English guide to ISO 9001:2015 — the international QMS standard. Risk-based thinking, process approach, leadership and the path to a clean certification audit.
ISO/IEC 17025 Chemical Testing Labs
Plain-English readiness guide to ISO/IEC 17025:2017 for chemical testing laboratories — competence, impartiality, method validation, measurement uncertainty and ILAC-aligned accreditation.
ISPE GAMP RDI Records & Data Integrity
Plain-English guide to the ISPE GAMP Records & Data Integrity (RDI) Good Practice Guide — ALCOA+, data lifecycle, hybrid records, audit trail review, and a defensible RDI programme aligned with MHRA, FDA, WHO and PIC/S expectations.
MDSAP
Plain-English guide to the Medical Device Single Audit Program — one audit, five regulators (US, Canada, Brazil, Australia, Japan). Audit model, grading, country-specific add-ons, and a path to a clean report.
MoCRA
Plain-English guide to the Modernization of Cosmetics Regulation Act — facility registration, product listing, safety substantiation, adverse-event reporting, and GMPs for cosmetics sold in the US.
NIS2 & DORA
Plain-English guide to NIS2 (Directive (EU) 2022/2555) and DORA (Regulation (EU) 2022/2554) for life sciences IT — scope, essential vs important entities, ICT third-party risk, 24-hour incident reporting and how NIS2 stacks on Annex 11 and GxP.
Paperless Validation Playbook: GAMP 5 Second Edition + FDA CSA in Practice
A practical playbook for moving qualification and CSV from paper protocols to a Part 11 electronic execution system — without breaking your inspection record.
Responsible Care RC14001
Plain-English readiness guide to the American Chemistry Council Responsible Care management system standard RC14001 — EHS&S integration with ISO 14001, Process Safety, Product Safety and Security Codes.
Software as a Medical Device (SaMD)
Plain-English readiness guide for Software as a Medical Device — IMDRF framework, FDA / EU MDR / UK MHRA expectations, IEC 62304 lifecycle, AI/ML PCCP, cybersecurity, and a 120-day path to a clean submission.
SQF Edition 9 Food Safety
Plain-English guide to the SQF Food Safety Code Edition 9 — system elements, food safety culture, environmental monitoring, unannounced audits and a path to a clean SQF certificate.
USP <797> Sterile Compounding
Plain-English guide to USP General Chapter <797> — pharmaceutical compounding of sterile preparations. Category 1, 2 and 3 CSPs, the BUDs, the cleanroom design, and a path to a clean state-board inspection.