The demand for unitary identification products and Track & Trace solutions has been fuelled by the sharp increase in regulations on an international scale. These numerous compliance requirements represent a major challenge for companies in terms of big data and information flow management.
As a pioneer in the field, Ackomas anticipated these regulatory developments by creating strategic partnerships to comply with EUDAMED and other international regulations governing medical devices. In addition, the company is already working with U.S. partners to comply with 2023 DSCSA requirements.
Scaling up serialization data
KOA, the Ackomas Cloud platform, is the only level 4 solution capable of centrally managing the regulatory requirements for the pharmaceutical and MD industries. The premium SAAS software combines a PIM (Product Information Management) and Track & Trace solution. Thus, it allows laboratories and manufacturers to take advantage of the powerful data generated by serialisation and Track & Trace processes. Developed using Microsoft Azure technologies, the data exchanged is completely secure.
KOA, a solution offering a wide range of benefits
Innovation – KOA uses state-of-the-art technologies that offer maximum performance and user comfort. It offers continuous operation and the “analytics” features for data processing allow for more efficient data usage. Alert and malfunction management is automated and files are analysed to process errors.
Security – Client databases are independent and secure. They are replicated, encrypted, and backed up. The client’s authentication system manages user access and unified role management using Azure Active Directory.
Flexibility – Secure, documented APIs allow for easy integration with clients’ information systems. The specific characteristics of the modular system allow us to add modules based on the clients’ needs, such as the management of data repositories.
KOA is a powerful tool. It ensures the effective operation of the internal MD market based on a high level of health protection for patients and end users. In addition, it significantly increases the effectiveness of MD safety activities after they are placed on the market. Finally, it reduces errors significantly and helps combat the falsification of devices.
Please contact us to learn more about all KOA’s features and how it can be adapted to your core business.
- Registration and storage of Basic UDI & UDI-DI data
- Synchronising data to Eudamed and tracking
- Tracking and traceability from the production line to the distribution centre
- Tracking and traceability by product batch and/or serial number
- Analysis of production data