RESULTS
Enhancing Operational Efficiencies
Since deploying Arena QMS, NanoDx™ employees have fully embraced the system. Each employee has access to certain functionality based on their specific role and user-defined access controls.
Cross-functional teams take advantage of Arena’s intelligent BOM and item management capabilities to expedite processes and minimize design errors:
- Marketing maintains product labeling and instructions for use (IFUs) within Arena.
- The software team loads requirements, specifications, and software iterations into the system. They have the flexibility to customize software release numbers according to their specific naming convention.
- Engineers load BOMs and associated drawings for printed circuit board designs.
By participating in Arena’s ECO process, these departments maintain visibility on product changes. Everyone can efficiently share and review documents and submit electronic approvals to meet FDA 21 CFR Part 11 requirements for electronic signatures.
Arena Projects allows NanoDx™ to manage the design history file (DHF) comprised of design inputs, outputs, etc. A project stage is assigned to each element of the DHF to track its status. Because all the product’s top-level assemblies and labeling link directly to the project, stakeholders can easily collaborate on open action items and work toward a successful completion.
Arena Training enables the organization to efficiently manage employee training and demonstrate compliance. Electronic signatures and time stamps are applied to each record once training is executed. In turn, NanoDx™ can compile complete training records for future audits. They are also configuring the Arena Training module to track equipment calibrations and preventative maintenance.
Another benefit for NanoDx™ is Arena Validate. It reduces the financial and administrative burden of software validation by providing a comprehensive set of validation documentation and reports to ensure FDA compliance.
NanoDx™ finds inventive ways to further streamline their processes using Arena’s advanced functionality and flexible platform. In lieu of spreadsheets, they’re developing an interface that can trigger Arena to create serial numbers and assign the proper values (i.e., manufacture and expiration dates, lot number, and serial number) through their label database. Since this information is tied to the assembly and revision controls are applied, they can ensure that product labels are always accurate.
As the company ramps up production and expands their use of supplier items in Arena, they plan to get contract manufacturers and other external partners on board with using the system.
Paving the Way for Commercialization Success
With their product and quality information now connected in a single digitized system, NanoDx™ is primed to reach their compliance goals and achieve commercialization success.
