Regulatory Considerations
Current FDA regulations encourage medical device companies to use the latest collection technologies and improve their delivery systems. Specifically, these regulations address the electronic processing of:
- Printed materials that are used in production
- Product components
- Quality assurance
- Packaging
- Labeling
- Installation
- Maintenance and services
The Problem with Manual Processing
With the existence of regulations, why do many medical device companies still maintain their Device History Records (DHR) on paper in today’s digital world?
The FDA targeted processing procedures because manual processes cause endless paper trails that are prone to error. The manual maintenance of paper-based device history records is time-consuming and expensive due to administrative overhead and FDA oversight. Not only does the continued use of paper require larger physical storage space, but it also complicates data retrieval creating a costly, error-prone, labor-intensive system.
Typically, a common process for creating and maintaining paper-based DHR’s involves these manual tasks:
- Documenting paper travelers
- Reviewing checklists
- Attaching work instructions, CAD drawings, and test results
- Numerous reviews to make sure everything is correct
The Solution
iBase-t takes an electronic approach to these FDA regulated tasks, bringing down the cost of compliance and significantly improving the usefulness of device history records. iBase-t has integrated all of the manual tasks into Solumina, a Manufacturing Operations Management (MOM) system that automatically updates the DHR as devices go through the production cycle. Solumina also accumulates all of the device’s process and consumption history.
Product Genealogy
Solumina automatically stores all of the histories on each device, including work instructions, data collection, buy-off signatures, discrepancies, tools used, rework, and a complete product genealogy. The product genealogy keeps track of all of the materials, components, and sub-assemblies used, and a complete tree of nested components for each device.
Solumina not only automatically maintains installation records, but it also maintains removal records. History for a sub-assembly and its components moves with that sub-assembly when it is removed. Product genealogy is maintained for products tracked by serial number, lot number, or work order number, and is preserved through work order splits and lot splits.
To maintain quality and reputation, Solumina users can locate specific lots or serial numbers to easily speed up recalls when a defect or hazard of a particular part or ingredient is identified.
Operator and Inspector Verification
In addition, during each operation, Solumina verifies that each operator and inspector has the required training, qualifications, and certifications to perform their assigned functions. The operator and inspectors are also warned about any certifications that are about to expire.
Operators and inspectors “stamp” work completion and approvals online. These buy-off stamps, date and time stamped with their electronic signatures, are stored as part of the DHR. Operators and inspectors can also identify an oversight or initiate discrepancy reports directly from a buy-off point from any work order.
Compliance
Solumina’s process control and enforcement mechanisms ensure compliance with ISO 13485, ISO 9001, FDA 21 CFR Part 11, and 21 CFR 820 regulations. This compliance enables customers to increase control over their process changes by providing the authentication and tracking of system activities against key business processes and sensitive data.
Solumina’s strict adherence to data collection ensures that each device meets the highest quality standards and compliance regulations. Non-acceptable data, such as out-of-limit data collections or duplicate serial numbers, are immediately identified and resolved. The parts cannot be moved into the finished goods inventory until all of the collected data are validated.
Conclusion
Solumina provides a complete MOM system that standardizes best-in-class quality management processes. These processes are tightly integrated with our customers’ ERP systems to ensure the delivery of quality products, consistently and with confidence. Because Solumina assembles a device’s DHR in real-time, it virtually eliminates all of the indirect costs of accumulating and validating this important information.