Design & Development System

The Design & Development System is a module within the eLeaP Quality Management System (QMS) that manages product and process development from concept through commercialization in regulated industries. It is built to maintain full traceability from requirements through validation, and supports compliance with ISO 13485, AS9100, IATF 16949, QMSR (21 CFR Part 820), ICH Q8/Q9/Q10, EU MDR, ISO 14971, IEC 62304, cGMP, and 21 CFR Part 11. The module is designed for organizations in medical device and IVD, pharmaceutical and biotech, aerospace and defense, automotive, food and beverage, cannabis and hemp, CMO/CDMO, clinical research, and software as a medical device (SaMD).

The system addresses common challenges in regulated product development: documentation packages compiled manually after development is complete, bi-directional traceability maintained across disconnected spreadsheets, design changes triggering manual updates across multiple documents, and training on updated specifications tracked separately from the development record. The module is designed to compile audit-ready records as work progresses, automatically identify traceability gaps, link risk analysis to design outputs, and cascade training assignments when specifications change.

Configurable Development Framework

• Adapts to waterfall, agile, stage-gate, or hybrid development methodologies.
• Allows configuration of phase gates, deliverables, and approval requirements based on product classification, regulatory pathway, and industry standard.

Requirements Management

• Captures and controls user needs, regulatory standards, customer specifications, and technical requirements.
• Maintains bi-directional traceability with automatic impact analysis when changes occur across any phase of development.

Dynamic Traceability Matrix

• Automatically generates and maintains traceability from requirements through design outputs, testing, and validation.
• Identifies gaps, orphaned requirements, and incomplete verifications in real time without manual spreadsheet maintenance.

Design Review Management

• Supports configuration of stage-gate reviews with role-based participants, customizable checklists, and action tracking.
• Accommodates formal design reviews, technical reviews, and agile sprint reviews with audit-ready documentation.

Verification and Validation Suite

• Supports creation, execution, and approval of test protocols with electronic signatures.
• Links test results directly to requirements and automatically flags deviations for investigation.
• Covers all testing types from bench testing through process validation and clinical studies.

Risk Management Integration

• Integrates risk analysis throughout development per ISO 14971, ICH Q9, AS9100, IATF 16949, or other applicable frameworks.
• Tracks hazards, controls, and residual risk with automatic documentation updates linked to the development record.

Technical Documentation Automation

• Automatically compiles design and development history records, technical documentation packages, and regulatory dossiers.
• Supports documentation requirements for FDA, ISO, IATF, AS9100, and other regulatory bodies.

Integrated Training Cascade

• When specifications change, the system automatically identifies affected personnel and deploys targeted training assignments.
• Tracks training completion and competency verification as part of the development record.
• Described as a distinguishing feature: training management is built into core QMS functionality rather than maintained as a separate system.

Development Transfer Protocols

• Supports scale-up and commercialization through transfer protocols, process validation requirements, and manufacturing readiness assessments.
• Links transfer activities directly to the development record.

Reported Benefits

• Faster regulatory approvals and certifications through automatically generated documentation aligned to major regulatory frameworks.
• Reduced development costs by eliminating redundant testing and documentation efforts through traceability and reusable templates.
• Improved first-pass success by identifying issues early through structured reviews and verification protocols.
• Streamlined regulatory inspections by providing auditors and investigators with instant access to complete development history, traceability, and risk documentation.
• Closed-loop competency management that connects specification changes to training assignments and verification before the next development phase begins.
• Cross-functional collaboration with role-based access and real-time project visibility across R&D, quality, regulatory, manufacturing, and operations teams, including across sites and supply chain partners.

The Design & Development System is part of the broader eLeaP QMS platform. It is available with a 30-day free trial and supports deployment across multiple industries and global regulatory frameworks. Medical device teams requiring design controls specifically under ISO 13485 or QMSR for FDA and EU MDR compliance are directed to a dedicated Design Controls System page within the eLeaP platform.