Read how hameln pharma connects an external warehouse largely with a standard interface and saves time through automated processes.
Summary:
The requirements for a validated ERP system that can withstand quality audits while simplifying processes led Ayanda to Yaveon. With the industry solution based on the Microsoft ERP, the company gained a system that meets the requirements of computer system validation – taking the fear out of quality audits. Now, security meets forward-looking efficiency.
A Thursday in November 2019, 6:28 p.m. The inbox of Yaveon’s Head of Quality and Compliance Management pings. It’s an email from a customer. Petra Duchrau, Head of IT at Ayanda GmbH, had just completed a validated ERP implementation together with Yaveon:
“We had a customer quality audit here today, and the auditor was very interested in computer system validation. He asked us to explain our approach and reviewed a sample chain of documents – from the BPML and the validation plan to the URS, FS, and risk analysis, through to the test plans and the validation report,” writes Ms. Duchrau in her email.
What did this mean?
Today, validating processes when introducing new computerized systems is much simpler than it was just a few years ago. The reason: the procedure has increasingly become routine. Another advantage: when companies implement their ERP system with an experienced partner whose products are developed in line with relevant standards such as GAMP5, they benefit from expertise and proven methods. The result is a standardized implementation that makes optimal use of the risk-based approach and reduces documentation effort, as the system can be classified as configurable standard software (GAMP Level 4).
But what is the best procedure when the task is not to implement a standardized new system, but to update an existing one? How can companies keep entities separate in certain data areas while fully converting transactional data? “In such cases, the key is to move away from well-worn paths and apply creativity and expertise in computer system validation,” explains Patrik Allmann, Head of Quality and Compliance Management at Yaveon AG.
This was precisely the challenge faced by Ayanda GmbH.
Ayanda GmbH is headquartered in Pritzwalk, a small town in Brandenburg located almost exactly halfway between Hamburg and Berlin. As a contract manufacturer, the company produces softgel capsules on behalf of its customers, drawing on many years of expertise in the production of pharmaceutical and nutraceutical products. This enables the company to more than meet the industry’s strict standards.
In 2008, three European companies from Norway, Finland, and Germany came together to form Ayanda.
When these companies were integrated, it quickly became clear: harmonizing products and organizations without a unified ERP system and shared master data would hardly be possible.
At that time, Petra Duchrau set out to find a suitable software partner: “During my research on the internet, I came across the Yaveon website. The offering looked like a good fit, and I was especially interested in the industry solution and the validation expertise.” Ms. Duchrau got in touch straight away. What followed was an exchange that convinced the entire management team.
“From the very first moment, it was clear that the consultants at Yaveon know process validation inside and out. Communication was excellent right from the start – always open and on equal footing.”
The first project with Yaveon began from the then headquarters in Norway: the implementation of the ERP system Microsoft Dynamics NAV along with the Yaveon industry solution. This solution is fully integrated into the ERP system and extends it with functions specifically relevant to the pharmaceutical industry. More about ERP for the pharmaceutical industry.
Ayanda makes particular use of the following functions:
“The goal was clear: to build a complete solution that could be rolled out equally at the sites in Finland, Norway, and Germany,” recalls Yaveon’s Head of Quality Management. To achieve this, a core solution was developed, and in each country a separate system was set up that included local adaptations, while master data was harmonized across all sites.
The very complex production processes proved to be challenging. Finding a suitable way to fully map them in the ERP system was not easy. But after a detailed analysis, various adjustments, and intensive training for production users, the right approach was found.
The project began in January 2010, and by October of the same year validated ERP systems were already in use in Finland and Germany.
Ayanda continued to develop: in December 2016, the German headquarters became part of the SIRIO Group. Established in 1993, the group is a specialist in the pharmaceutical and nutraceutical industries.
With this development, Ayanda knew it needed a standalone ERP system. At the same time, the company wanted to seize the opportunity to invest in a modern solution and optimize its processes.
The project had the following objectives:
The company’s development showed that a standard ERP implementation was not possible. While the GAMP 5 model provides for comparing requirements with system functionalities, creating User Requirement Specifications (URS) and Functional Specifications (FS), identifying development needs, and conducting a GMP risk assessment, Ayanda faced a different challenge: a complete update with data conversion involves several testing phases across multiple release stages and numerous iterations. The actual data conversion only takes place at the time of go-live, since work continues in the existing live system until then. In addition, both conversion and software can be adjusted right up to the go-live. But why?
The reason lies in practical operations: in the system to be replaced, work continues until the very last moment, which means real (data) constellations can change again and again.
Together with Yaveon, Ayanda found a suitable approach for validation: the method follows the GAMP 5 model. Required documents such as URS and FS were created and approved during the course of the project. Also included: risk analyses and test plans for the data conversion. Using test data from the current iteration of the data conversion at that time, functional and acceptance tests were also carried out on the validation system.
By far the greatest changes took place in the area of adapting the legacy system: all iterations repeatedly involved test conversions.
Because a very large amount of data had to be modified, it was not possible to describe procedures and changes in exact detail. Inconsistencies in the data were immediately identified during each conversion run and eliminated until the conversion could be completed without error messages. In each phase, tests were also carried out:
Based on the findings, Ayanda and Yaveon jointly created an independent and formal test plan. The scope was based on Risk Analysis III – meaning GxP-critical processes and functions with the associated data. As a result, the tests consisted of:
The formal test of the conversion was carried out as part of the qualification of the overall system and therefore on a validation system. Since up-to-date data were required for the actual go-live, objects and necessary setup data could be transferred from the qualified overall system.
Important here: convert all data current as of the go-live.
Before the system was released, additional tests were carried out to ensure the accuracy of the data:
The definition of the respective test scope was risk-based. Based on pre-defined conversion checklists, it was also confirmed that all required activities were complete and that execution had been performed without error messages.
The system went live on January 1, 2019.
Whether thinking about the first project or the update project, Petra Duchrau is satisfied. She and her team felt well supported and were able to ask questions at any time – especially in the early phase, personal contact was very important. “It was very important to us that we could carry out the validation ourselves. This plays a major role in the pharmaceutical industry.” Frau Duchrau also recalls many web sessions during the project. The remote work ran smoothly and saved both sides a great deal of time and cost.
The users at Ayanda enjoyed working with the ERP system from the very beginning, and since the update additional advantages have been added: the system is particularly flexible and intuitive to use in the administrative area. Another helpful feature is that all lists can be exported to Excel. Onboarding new employees is also easier, since a profile can be set up for each user in advance. This way, they only see the functions relevant to their area of work.
And what about Frau Duchrau’s email? It was a positive message that reached Yaveon’s Head of Quality Management. Frau Duchrau had written to thank him for the good support and expert advice provided during the project. Thanks to the successfully implemented validated ERP system and the industry solution, Ayanda can approach every quality audit without concern and can focus much more on its day-to-day business.
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