Sandoz is using READY! to verify, validate, and submit XEVMPD product information to the EMA Gateway according to the Article 57 regulation.
Sandoz has successfully submitted more than 150,000 XEVPRM messages, so this makes it one of the largest installations in the pharmaceutical industry.
The solution has performed without a glitch from day one, including the latest implementation of the 3rd Acknowledgement.
About the project:
The new regulation from the EMA regarding Article 57 and the mandatory submission of complex information about a large number of medicinal products has meant a dramatic shortage of implementation time.
Sandoz, one of the largest companies in the pharmaceutical industry, had an even greater challenge because they have such a vast product portfolio. Sandoz needed to integrate the solution with their existing systems – this is an additional challenge because out-of-the-box solutions had to meet their specific needs and IT environment.
The solution had to be a gateway solution with built-in validation prior to actual submission.
They had to choose the best system that would meet all of these requirements, and that could be implemented quickly, and according to the highest standards.
The project was finished highly successfully, on-budget, and in time.
• READY! software with a built-in ESTRI gateway
• On-time delivery
• Implementation advice
• Computer validation
• The capability to meet their quality objectives
• A dependable system that was up, and is still running without a hitch
• A system to submit a large number of messages
• Assistance 24/7