Carecubes gained traceability for compliance through Duro
Carecubes, in partnership with research and innovation lab Otherlab, develops a patient isolation device for hospitals. The product consists of a frame from which a canopy is suspended as well as a fan and air filtration. This creates a safe environment in which to treat infectious patients.
At the beginning of the project, Carecubes was using Google Docs to manage product information. They also relied on DocuSign for approvals and managing and locking digital files. Manual processes required to download and email pdfs made it a challenge to ensure individuals were signing documents in a timely manner. As the company grew, they knew they needed a full PLM solution to release, manage and track changes in their designs. One key factor in switching to Duro was the need to have Part 11 compliant signatures, a regulation which specifies how electronic signatures are verified and documented.
The team chose Duro because the user interface is easy to navigate. The tool was flexible enough to work for both managing designs and revisions as well as allowing the quality team to track Standard Operating Procedures (SOPs).
Today, employees from Carecubes (and Otherlab) use the tool to collaborate and share product information. The Research and Development (R&D) teams responsible for designing a device use Duro to manage their parts and revisions. The Quality team uses Duro to control documentation in compliance with regulatory requirements. The primary uses for Duro PLM include:
- BOM Management: The R&D team uses Duro to manage BOMs for devices including those that will be in the market as well as prototypes. The tool also allows them to keep track of where the parts come from and how much they cost.
- Approving ECOs: Duro helps the teams follow procedures around how components are reviewed, approved and released. Every Engineering Change Order (ECO) must gain unanimous approval from a mechanical engineer, operations and quality engineers.
- Revision control: Duro’s revision control is critical for finding the current status of a design. This is an important part of medical device compliance for required documentation to release test reports to appropriate revisions.
- Managing SOPs and test protocols: Carecubes has multiple SOPs which explain how to handle complaints, production as well as Corrective and Preventative Actions (CAPA). The team uses Duro to manage every SOP alongside reports and test protocols. Duro provides a centralized hub for storing and approving these documents and their revisions over time.
- Cross-departmental collaboration: Once a design reaches a certain level of maturity, it goes into Carecubes’ formal product design development process which includes gathering feedback and approvals using Duro. Carecubes also feeds information back to the R&D team about problems that need fixing or additional requirements for the design engineers.
The partnership has given Carecubes a reliable system for managing and approving their documentation. The team gained the following capabilities from using Duro:
- Compliance: Being able to track signatories, revisions and test results ensures Carecubes can provide relevant materials for the FDA.
- Collaboration: Duro has enabled them to easily access, manage and approve documentation from any location.
- Quality control: Using Duro has helped the team manage quality tracking as they build the business, including SOPs, work instructions, and revisions.