In highly regulated industries like pharmaceuticals, medical devices, automotive, and aerospace, strict standards govern every step of the manufacturing and testing process. These regulations are crucial to ensuring the highest levels of safety and product quality. However, achieving compliance demands implementing systems and processes that deliver strong security, comprehensive traceability, and meticulous management and auditing of user interactions.
The Advanced Authorization and Authentication (A3) software for Sprint mD and Optima vT simplifies compliance with rigorous regulatory guidelines for manufacturing and testing. The A3 feature provides enhanced security, streamlined instrument control, and comprehensive traceability to meet strict regulatory standards such as 21 CFR Part 11 and EU Annex 11.
In its basic form, the instrument is limited to three user accounts: admin, supervisor, and operator. Without A3, the admin user can only modify the names and passwords associated with these accounts.
Enabling A3 locally offers a highly flexible user management system, allowing you to add, delete, or modify users and configure roles and permissions to suit your operation's specific requirements. Administrators can also enforce strong password policies and maintain a comprehensive audit trail log, enhancing traceability by recording every change to test parameters. This setup is especially valuable for companies seeking to maintain strict internal control over their testing environment.
When A3 is configured for network communication , user management and authentication are handled through your organization’s local network via LDAP (network directory) services. This setup allows for seamless integration with your existing IT infrastructure while maintaining the ability to manage user roles, permissions, and audit trails. If the network connection is lost at any time, the instrument reverts to the default local user settings, ensuring uninterrupted product and part testing.
With A3, you can reduce the risk of errors and enhance overall system security by defining user roles and ensuring that only authorized personnel can modify particular functions and settings within the instrument environment.
The A3 software feature for Sprint mD and Optima vT provides a robust framework for ensuring the security, traceability, and compliance of your testing and manufacturing processes. By offering flexible configurations tailored to your operational needs, A3 empowers your organization to maintain control over critical test data while meeting regulatory standards.
Whether you are operating in a highly regulated industry or simply seeking to improve the security and efficiency of your testing processes, A3 provides the tools and capabilities you need to achieve your goals. With A3, you can be confident that your operations are secure, compliant, and ready to meet the challenges of today’s demanding regulatory environment.