CQ’s Design Controls Solution: A Big Step Forward

We’re excited to announce the launch of the cloud-based Product Design Management Solution from ComplianceQuest. We believe that it’s a big step forward in our roadmap, playing a key role in helping our customers automate and streamline their overall quality management and compliance efforts across the entire product lifecycle. Over the years, we’ve worked very closely with our customers to launch new features, capabilities, and solutions. So, our Product Design Management Solution was born out of our deep understanding of what our customers are experiencing and expecting us to deliver for them in their next phase of digital transformation.

In this blog, we introduce you to CQ’s Design Controls Solution, which is a key product in our Product Design Management vertical.

But, before we get into that, we explain what are some of the gaps in the market and why a Design Controls solution that seamlessly integrates with a truly next-generation EQMS solution with integrated risk management is critical.

What are Design Controls?

The Food and Drug Administration (FDA 21CFR 820.30) defines Design Controls as “a set/framework of quality practices and procedures incorporated into the design and development process of a medical device product to assure that device specifications meet user needs and intended use(s)”.

Design controls enable integrating a systemic approach to design during the product development lifecycle to:

• Proactively identify gaps in design input requirements as early in the lifecycle as possible
• Recognize any discrepancies between proposed designs and final requirements

The key is to spot design issues as early as possible in the product development lifecycle and avoid risks to patient safety or costly product recalls. It requires a collaborative approach among various departments to ensure design conformance to user needs.

Why Design Controls and Quality Management go Hand-in-Hand?

The key aspect of design controls is that it is closely integrated with the quality system across various parts of the workflow covering design, manufacturing, supply chain, logistics and ongoing maintenance and upgrades. Most organizations document design controls requirements in the quality policy document.

The other three parts of the quality system are risk management, document control, records management, and supplier management.

It is important to note that design controls play an essential part in any changes introduced to the device or the manufacturing process, even after the product has been released. Changes could include new features, updated functionalities, or correction of any causes of failure.

Overall, just like quality management, design controls is an ongoing effort that requires a proactive approach with a mindset of continuous improvement.

The important aspect to note here is that any flaws in design will have a direct impact on quality performance. It is, therefore, critical to automate the design controls workflow and completely integrate it with the EQMS Solution.

Understanding the Product Development Lifecycle

The product development lifecycle typically covers the following phases:

• User Needs
• Design Input
• Design Output
• Design Review
• Design Verification
• Design Validation
• Design Transfer
• Design Change

A Requirements traceability matrix becomes crucial for the product development teams to understand the relationship and linkages between the different design controls.

The requirements traceability matrix is an industry best practice that provides a high-level view of the flow of medical device product development from start to finish. It is also a requirement in ISO 13485:2016.

While in the initial stages, a traceability matrix might be maintained in manual tools such as Excel. But as the complexity increases, it can become impossible to track using only a spreadsheet.

Using an automated, cloud-based solution such as ComplianceQuest to automate the entire design controls process and workflow can be a game-changer. It improves the productivity of key employees, saves time, enhances collaboration among diverse teams and ensures the design controls process is effective.

Understanding the Challenges in the Design Controls Process

Implementing Design Controls poses several challenges. Some of these include:

Overwhelming Documentation: Business leaders and decision-makers are grappling with design documents that run in several thousands of pages. From 1983 to 2017, number of pages in design files for a 510(k) submission increased by >2,000%. It is also getting really difficult for various stakeholders to manage document revisions, get required signatures, etc.

Collaboration Across Departments is Not Easy: In today’s world of collaboration, remote work and hybrid teams, it is critical to have “anytime, anywhere” access to documents. In the case of design controls documents, there must be an easy way for engineering, quality and regulatory teams to access, revise and track documents and also ensure “a single source of truth” for all design-related documentation.

Numerous Changes & Updates that Must Be Tracked: All changes and updates must be tracked, documented, and approved according to regulatory standards. In the case of medical devices, a minor change in one small aspect of the design can cause a massive impact. Therefore, any change must be accompanied with necessary documentation that captures the change made, tests and verification procedures followed, etc.

Proactively Managing Risks is Challenging: It is a real challenge for teams to assess, identify and mitigate all risks, especially if relying on spreadsheets or papers. Having an integrated risk-management solution will be a game changer in the long run.

Cloud-based Design Controls Solution from ComplianceQuest

A cloud-based Product Design Management Solution from ComplianceQuest can help businesses manage design controls better and overcome the challenges. The solution is integrated with the CQ EQMS, thereby providing instant access to risk management and documentation solutions, among others.

The 5 key features of the CQ Design Controls software include:

Projects

• Meeting Management: Allowing easier collaboration, as well as design review and detailed documentation
• Gantt View: Weekly or monthly view of tasks completed for better project management
• Project Deliverables: The ability to add deliverables for each stage of design (plan, development…) and track progress for each one
• Project Records: To assign deliverables, facilitate project management and simplify collaboration for product design teams
• Team Collaboration: An easy-to-use platform with integration with Microsoft Office and Google Docs for document collaboration

Design controls

• Integrated: Can bring in data (ex for parts) from ERP or other systems
• Product Design Files (Design Control): A living record across a product’s lifecycle that documents all design-related activities and serves as one source of truth for the design process (RTM, Parts, Documents…)
• Configurable Queues: Customers can configure the workflow and approval matrix queue to fit their needs and processes
• References & History: Effortless and always up-to-date documentation

Requirements Traceability Matrix

• Formatted Printouts: Customers can print RTMs and design files as needed – with built-in numbering and revision control
• Change Orders: To compliantly implement minor changes to products with all required steps and documentation

Product Risk

• Single View: An always up-to-date living document that allows you to link and track all requirements, inputs, outputs validations, and verifications
• Change Alerts: Automatic change alerts in RTMs for records to ensure all changes are reviewed and implemented appropriately
• Requirements per Part: Define and track design controls per product part
• Easy Edit: allowing for seamless updates to requirements as needed

Design History File

• Product Assessment: Document all product-related risks, with risk assessment and classification
• Product Risk Control: Document risk control measures, control verifications, and residual risk analysis

With CQ’s Product Design Management Solution, customers can do the following:

• Bring their products to market quicker by gaining 100% visibility and traceability of the product development process
• Our solution makes collaboration easier, offering design teams better control over design inputs, requirements, and risks to improve product quality
• It streamlines the process of compliance documentation and regulatory requirements (including FDA and ISO)
• Our customers can also leverage the CQ EQMS features such as document, change, CAPA, and management review

To know more about CQ’s Design Controls Solution, request a demo here:
https://www.compliancequest.com/lp/design-control/