Design Quality

All departments involved must be able to easily access shared records, not only engineering teams, but quality and regulatory teams as well.

CQ offers your teams a unified repository for all design documentation including requirements, deliverables and changes, easily accessible to all members. You can even bring in product data from other sources (ERP, Jira..) and keep your quality and engineering teams in sync, with a complete document stack.

Design leaders need a strong project management solution that is tailored for design projects and allows them to track actions, deliverables and timelines and that is easily accessible by all relevant team members.

With CQ’s Design Quality solution you can easily assign actions to team members and follow up on them to make sure they are completed on time. Deliverables are instantly added to new projects thanks to a configurable Deliverables Library. It’s also easy to keep track of all deliverables during all stages of the design lifecycle with advanced list views and Gantt charts that ensure each component receives the attention it needs.

Your Design History File (DHF) and Device Master Records (DMR) need to always be ready, up to date, easy to locate and share.

With CQ’s Design Quality, automatically your DHF and DMR are built for you and kept up to date with the latest approved documents and design files. Your teams can access these critical folders at any time, search through them and share relevant documents with the click of a button.

All changes and updates must be tracked, documented and approved according to regulatory standards but extensive documentation can inhibit efficiency, leading to delays, mistakes and non-compliances. For teams using paper systems, or spreadsheets maintaining proper documentation can quickly become a nightmare.

CQ’s Design Quality solution makes documentation effortless for quality and engineering teams. All steps, requirements, outputs, reviews, and changes are well documented and easily shareable/printable at the click of a button. Even approvals, signatures, revisions and meeting notes are automatically documented, with built-in revision control for design files. This ensures compliance with regulatory and quality standards such as 21 CFR 820.30 and ISO 13485.

Design review meetings are crucial in ensuring design process deliverables are being sufficiently performed, design plans are updated and that all steps are being taken to deliver a high-quality product.

CQ’s Design Quality solution allows you to schedule and manage design review meetings in one place. You can assess project progress, assign, and easily track assigned actions during the meeting and meeting minutes are automatically documented for full traceability.

Teams often struggle to maintain visibility and control over requirements throughout the product lifecycle, leading to gaps in compliance, missed updates, and increased risk.

ComplianceQuest’s Requirements Traceability Matrix (RTM) offers a centralized, continuously updated framework that links requirements to design controls, ensuring all elements are clearly defined, consistently tracked, and always current. By mapping requirements to design controls, ComplianceQuest enables teams to verify that all controls are properly defined and maintained, reducing risk and ensuring compliance. Built-in automatic change alerts keep stakeholders informed of updates, enabling teams to review and implement changes seamlessly. With features like per-part requirements tracking and easy editing, ComplianceQuest empowers organizations to maintain accuracy, enhance collaboration, and streamline product development from concept to launch.

Achieving consistent product quality requires clear, well-managed control over every process step. Without structured control plans, organizations risk variability, inefficiencies, and compliance gaps.

ComplianceQuest’s Control Plans enable organizations to define, document, and manage the actions required at each step of a process to ensure outputs meet predetermined quality requirements. It streamlines the creation, linking, and management of process steps, product and process characteristics, and controlled documents, while delivering real-time visibility and enabling seamless collaboration across teams. Published Control Plans are seamlessly integrated into the Design History File (DHF), ensuring end-to-end compliance and traceability across the product lifecycle. By combining control plan best practices with powerful digital tools, ComplianceQuest helps manufacturers improve process control, reduce variability, and deliver consistent, high-quality products.

Identifying and addressing risks early is critical to ensuring product quality and compliance. Without structured analysis, potential failures in design or manufacturing can go unnoticed, leading to costly issues later in the lifecycle.

ComplianceQuest’s Failure Mode and Effects Analysis (FMEA) solution helps organizations identify, evaluate, and mitigate potential risks in both design (DFMEA) and manufacturing processes (PFMEA). The platform streamlines risk assessment with real-time visibility, standardized scoring, and collaborative workflows to improve product quality and ensure compliance. It also provides purpose-built automotive FMEAs aligned with the AIAG-VDA FMEA Handbook, enabling automotive manufacturers and suppliers to meet industry- specific standards with ease. By integrating proven FMEA best practices with advanced digital tools, ComplianceQuest empowers teams to minimize risk, accelerate innovation, and enhance operational excellence.