Table of Contents
Client Overview
The noxVIEW team had performed an upgrade project on Steriline filling line at Eugia Pharma Specialties at injectable Facility located in Hyderabad
Challenges
- 21 CFR Part 11 Requirements: Ensuring that the SCADA system complies with 21 CFR Part 11, which includes secure, computer-generated, time-stamped audit trails, electronic signatures, and system validation
- Workflow Integration: Integrating the SCADA system into existing complex workflows without disrupting production processes with a very short shutdown time.
Solution
- Detailed Planning: noxVIEW team developed a comprehensive project plan that includes timelines, resource allocation, risk management, and contingency plans.
- Tailored Solutions: Armed with domain knowledge, the team could tailor their solutions to meet the unique needs of the pharmaceutical industry, including compliance with regulatory standards such as 21 CFR
Results
- As a result, the successful delivery of the 21 CFR-compliant SCADA software by the noxVIEW team demonstrates the value of expertise, efficiency, and effective project management in minimizing downtime and maximizing operational performance in the pharmaceutical industry.
