To help ensure that medical devices are safe for use and will function as intended, the FDA requires that manufacturers of these products establish and follow quality systems in accordance with current good manufacturing practices (CGMP). While the quality system regulation (QSR) does not prescribe how a manufacturer must produce a specific device, it does state that manufacturers “should use good judgment when developing their quality system and apply those sections of the QS regulation that apply to their products and operations.” The QSR further specifies that it is the responsibility of each manufacturer to establish the appropriate methods and procedures to design, produce, distribute, and deliver devices that meet the quality system requirements.
The decision of how to best manage the quality system rests with the device manufacturer and typically involves the selection of a quality management system (QMS) software solution. Factors like expediency, budgets, incomplete articulation of needs, and the objectives of key leaders and teams can often steer QMS solution decision-making in a direction that is not always in the best interest of the manufacturer.
Having a steadfast focus is key to identify the best QMS solution to optimize visibility, control, traceability, and the ability to collaborate easily. Every stakeholder, including those focused specifically on quality, should consider the entire product release process to avoid myopic decisions. It is important to account for siloed systems and teams to ensure everyone has full context throughout the new product development and introduction (NPDI) process.
If you are evaluating which way to go in selecting or replacing a QMS solution, here are five key questions you should ask to assess your quality needs and ensure your broader business objectives can be fully met.
1. Does the QMS manage the entire product record?
Successful quality leaders recognize that product records for complex medical devices are more than just a set of documents—they include an array of components, assemblies, and more. The entire product record, including the bill of materials (BOM), needs to be captured, controlled, and managed with direct links between all the associated quality records and processes. This not only enables better traceability, but also promotes design improvements and collaboration across teams.
While traditional document-centric QMS solutions may suffice to manage simpler medical devices or life sciences companies focused on pharmaceutical products, they have significant gaps when it comes to managing the entire product record and BOM for complex devices comprised of vast amounts of mechanical, electrical, and software components. To address this gap, product-centric QMS solutions manage a relational, hierarchical BOM by directly linking drawings, specifications, manufacturing work instructions, SOPs, training records, and many other documents. This gives quality and the entire product team a complete picture of all records and processes to ensure devices work as designed, while complying to FDA or other regulations.
2. Does the solution elevate my corrective and preventive actions (CAPA) process?
When a problem occurs with a medical device, having a way to quickly identify the root cause and correct the problem is critical. For example, an MRI machine might be stalling during patient exams. Tracking the source of the stall can be a challenge—is it software, electronics, or how those two systems interact? Determining the cause requires thorough documentation of the issue and the ability to efficiently drill into the product design record and sometimes the manufacturing process. Only after the what/when/why/where/how questions are completely answered, can a proper fix or corrective action be identified and carried out.
To design, test, and deliver high-functioning products, it’s important to have a quality system that improves visibility and traceability between the product design and the CAPA process. The foundation of an effective CAPA process should start with the product. Without that foundation, quality and product information are siloed, making it harder to correct quality issues relating to the product design.
The product design is more than a list of components and must include all relevant specifications, procedures, and training records from everyone involved in helping to get the finished device to market. A comprehensive QMS provides a way to plug in all related documents to establish context at all times between product and quality processes, simplifying investigation and the ultimate resolution of issues.
3. Does the QMS help disparate teams collaborate easily?
Providing role-based access to internal and external teams to ensure the right information is accessible by the right people at the right time. Proactive, real-time notification speeds collaboration. And providing historical audit trails of design, test, and approval processes is critical to prevent cross-functional team-related issues. If an organization’s current QMS solution can’t easily allow access to all impacted players at every stage of the release process, potential product development and quality issue resolution delays are more likely to occur. Additionally, failing to prevent or identify issues until after the product has gone to market makes corrective actions more expensive and can lead to negative impacts on patient health.
While having the right level of access and visibility throughout the NPDI process is key, the ability to easily collaborate simply between internal teams and external partners cannot be understated. By connecting all teams with and enabling online reviews, a product-centric QMS streamlines communication, eliminates design errors, and spurs innovation. Multi-disciplinary collaboration supported with product, documentation, and quality information in a single QMS system removes blind spots and helps ensure reliability and manufacturability. Every issue cannot always be foreseen or prevented, so when issues do occur (and they will), a product-centric QMS solution offers the best way to shorten the time to resolution.
4. Does the QMS support quality processes throughout the product lifecycle?
The importance of quality management doesn’t diminish after initial compliance to regulations is met or products are delivered to market. However, manual or document-centric QMS solutions can unintentionally support that notion due to limited visibility to the product record.
Medical device companies must have a fully traceable quality and design process that spans many years and affects many patients. Since quality issues can arise before or after devices have gone to market, having a QMS solution that provides an historical audit trail for everyone involved in designing, testing, delivering, and sustaining medical devices is a key requirement. This provides better visibility and guarantees traceability throughout the product lifecycle.
5. How difficult is it to validate the software?
The FDA requires medical device manufacturers to validate software used in the design or delivery of devices. However, validation is typically considered to be an overhead cost required to satisfy the FDA and it requires a fair amount of resources, understanding of the software, and specific use cases. Validating older on-premises or document-centric QMS software solutions tends to be labor-intensive, inefficient, and is often avoided by quality and regulatory teams leaving customers stuck on older versions as they decide to avoid the validation process altogether.
Cloud-based QMS solutions with multi-tenant architecture eliminate traditional obstacles and alleviate resource challenges, thus simplifying a large portion of the validation process. Arena’s cloud-based QMS solution was designed with a validation perspective in mind. Each new software release is supported with a validation maintenance service (VMS) by a team of Arena quality and validation experts to reduce the time to validate its software. This service enables quick compliance while allowing customers to focus on their core competencies. And more importantly, it ensures medical device customers can receive the benefit of every software enhancement.
Introducing a safe, compliant, and innovative medical device to market is no easy feat. However, by asking these five questions, you can take steps to adopt a QMS system that meets the regulatory requirements and speeds product launches by leveraging a connective and collaborative solution.
Are you using manual or older QMS software solutions? Do you have multiple systems used by quality and product teams? Let us know what challenges you want to solve to deliver high-quality products faster and more effectively.