Table of Contents
Client Overview
The noxVIEW team had performed an upgrade project on the vial sealing machine for Groninger at Baxter pharmaceutical (injectable-SVP) facility in Ahmedabad.
Challenges
- Incompatibility: Older systems do not support the technical requirements necessary for 21 CFR compliance, such as audit trails, electronic signatures, and robust user access controls.
- Integration: Integrating new compliant systems with existing legacy systems is a complex and require custom solutions.
Solution
- A solution for upgrading the capping machine, noxVIEW conducted a comprehensive reverse engineering process due to the absence of a backup. This involved performing a detailed individual tag mapping activity & testing activity.
Results
- As a result, noxVIEW delivered the 21 CFR-compliant SCADA software to meet the standards required for their upcoming USFDA audit, ensuring the machine is ready for future scalability
