ComplianceQuest’s Design Controls Solution gives you complete visibility over your product design process, making it easy for your teams to collaborate and design high quality products, all the while guaranteeing compliant and comprehensive documentation.
Design Controls
Bring higher quality products to market quicker with full compliance and comprehensive documentation. Help your quality and engineering teams stay in sync with a single source of truth for all your product design activities.
Remove the headache of documentation and compliance from your product design process with living and always-up-to-date design files which are shareable with the click of a button
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Collaboration between different members for critical tasks such as revisions or validations can be a challenge, especially if done through spreadsheets.
With CQ’s Product Design Management solution, design leaders can invite their teams to work on easily accessible design files, as well as assign and track actions for each team member based on deliverables. Modern collaboration tools such as Chatter and Design Review management are built-in to help teams collaborate in real-time while maintaining effortless documentation of project progress.
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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.
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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 Controls 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.
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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 Controls, 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.
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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 Product Design Management 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.
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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 controls 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.
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Support your Entire Organization
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Management
Reduce costs and increase product quality with a comprehensive and systematic approach to product development that satisfies all quality and regulatory requirements.
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Engineering
Gain complete visibility over product design development process and simplify documentation for your teams so they can focus on innovation.
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Quality Leaders
Ensure that proper quality processes and procedures are easily implemented throughout development efforts along with comprehensive and up to date documentation.
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Regulatory
Minimize human errors, simplify documentation, and ensure compliance with relevant quality and regulatory standards.
What they Say About Us
Design Controls Features
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Complete Product Design Files
Living record across a product’s lifecycle that documents all design related activities parts, and requirements.
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Design History File
A unified repository for all design documentation, easily printable and accessible to all members.
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Device Master Record
The latest approved design output documents always up-to-date and accessible to all members.
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Project Management
Assign deliverables, facilitate project management and simplify collaboration for product design teams.
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Design Review Meetings Management
Schedule and manage design review meetings in one place, and track assigned actions along with detailed documentation of meeting minutes.
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Gant View for Deliverables
Add deliverables for each stage of design (plan, development…) and track progress for each one in either list or Gantt View.
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Easy Publish
Generate and print design data, documents, and records with one-click at any time during the product lifecycle.
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Team Collaboration
An easy-to-use platform that provides integration with Microsoft Office and Google Docs for document collaboration.
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