Eight regulatory workspaces form the shelf.
source-backed · public-readyEU AI Act
A source-to-use workspace for reading Regulation (EU) 2024/1689, connecting official articles to interpretation, evidence planning, public checklists, and regulated life-sciences use cases.
Open workspace →FDA Quality Management System Regulation
A workspace for understanding FDA QMSR implementation, quality system evidence, device-maker transition planning, supplier controls, complaint handling, CAPA, and audit readiness.
Open workspace →FDA Computer Software Assurance
A workspace for translating FDA CSA guidance into validation strategy, intended-use logic, risk-based testing, electronic records, and automation-friendly quality evidence.
Open workspace →GAMP 5 and AI Validation
A workspace for GAMP 5-aligned validation thinking, AI and machine learning control questions, supplier assessment, computerized system lifecycle, and GxP evidence expectations.
Open workspace →ICH E6(R3) Good Clinical Practice
A workspace for reading ICH E6(R3) through operational trial execution, quality-by-design, proportionate risk management, essential records, oversight, and digital trial practice.
Open workspace →Good AI Practice
A workspace for mapping good machine learning practice, lifecycle controls, multidisciplinary accountability, transparency, monitoring, and evidence expectations for regulated AI use.
Open workspace →ISO/IEC 42001 AI Management System
A workspace for understanding ISO/IEC 42001 as a management-system scaffold: policy, roles, risk, impact assessment, lifecycle controls, monitoring, and governance evidence.
Open workspace →AI-enabled MedTech and SaMD
A workspace for AI-enabled software as a medical device, predetermined change control, clinical evaluation, real-world monitoring, cybersecurity, UDI, and post-market evidence.
Open workspace →Every public asset must trace back to source.
no overclaimingCore source anchors are kept visible.
official firstRegulation (EU) 2024/1689
AI literacy, high-risk classification, transparency, human oversight, technical documentation, and health-tech deployment context.
FDA QMSR overview
FDA QMSR final rule, 21 CFR Part 820, ISO 13485 alignment, transition controls, inspection readiness, and quality records.
FDA CSA guidance page
Computer Software Assurance for Production and Quality System Software, risk-based validation, intended use, assurance activities, and evidence records.
ISPE GAMP 5 Second Edition
GAMP 5 principles, computerized system validation, AI/ML change control, supplier assurance, data integrity, and GxP lifecycle evidence.
ICH E6(R3) guideline page
ICH E6(R3) principles, Annex 1, sponsor/investigator responsibilities, quality by design, risk proportionate approaches, and clinical trial records.
FDA GMLP guiding principles
Good machine learning practice, AI lifecycle governance, model monitoring, human factors, transparency, and regulated evidence expectations.
ISO/IEC 42001 overview
AI management system scope, leadership, planning, support, operation, performance evaluation, improvement, and AI impact assessment links.
FDA AI/ML-enabled medical devices
Software as a Medical Device, AI/ML-enabled device lifecycle, PCCP, clinical evaluation, real-world performance, cybersecurity, and post-market change control.