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 withstands quality audits and facilitates processes led Ayanda to Yaveon. With the industry solution based on Microsoft ERP, the company received a solution that meets the requirements of computer system validation and thus takes the fear out of audits. Now security meets future-oriented efficiency.
A Thursday in November 2019, 6.28 pm. The email inbox of the Head of Quality and Compliance Management at Yaveon goes "ping". It's a message from a customer. Petra Duchrau is Head of IT at Ayanda GmbH and has introduced a validated ERP system together with Yaveon:
"We had a customer audit in-house today, where the auditor was very interested in computer system validation. He had our approach explained to him and examined the chain of documents as an example, from the BPML and the validation plan, via the URS, FS and risk analysis to the test plans and the validation report," writes Ms. Duchrau in the email.
What did that mean?
Today, it is much easier to validate processes when introducing new computer-aided systems than it was a few years ago. This is because the procedure has become more and more routine. Another benefit: if companies introduce their ERP system with an experienced partner who has developed their products based on relevant specifications, such as GAMP 5, they can rely on experience and expertise. The result is a standardized implementation that makes optimal use of the risk-based approach and reduces the documentation effort, as the system can be classified as parameterizable standard software (GAMP Level 4).
But what is the best approach if no standardized new introduction is planned, but an update for an existing system is pending? How should companies in certain data areas be separated and transaction data fully converted at the same time? "The motto in this case is to leave well-trodden paths and use creativity and know-how in the field of computer system validation," explains Patrik Allmann, Head of Quality and Compliance Management at Yaveon AG.
Ayanda GmbH faced precisely this challenge.
But what is the best approach if no standardized new introduction is planned, but an update for an existing system is pending? How should companies in certain data areas be separated and transaction data fully converted at the same time? "The motto in this case is to leave well-trodden paths and use creativity and know-how in the field of computer system validation," explains the Head of Quality and Compliance Management at Yaveon.
Ayanda GmbH faced precisely this challenge.
Ayanda GmbH is headquartered in Pritzwalk, a small town in Brandenburg, almost exactly halfway between Hamburg and Berlin. As a contract manufacturer, the company produces softgel capsules on behalf of customers, drawing on many years of experience in the manufacture of pharmaceutical and nutraceutical products. The company therefore more than meets the high industry standards.
2008 saw the merger of three European companies in Norway, Finland and Germany.
When the companies were integrated, it quickly became clear that harmonizing the products and companies without a uniform ERP system, combined with common master data, would hardly be possible.
Petra Duchrau set out to find a suitable software partner: "While researching on the Internet, I came across the Yaveon website. The offer sounded suitable, and I found the industry solution and validation experience particularly interesting." Ms. Duchrau contacted them directly. An exchange began that convinced the entire management team. "It was clear from the very first second that the consultants at Yaveon knew all about process validation. The exchange was very good and on an equal footing right from the start."
The first project with Yaveon began from the then headquarters in Norway: the introduction of the Microsoft Dynamics NAV ERP system and Yaveon's industry solution. It is fully integrated into the ERP system and expands it with the functions that are relevant for the pharmaceutical industry. More about ERP for the pharmaceutical industry.
Ayanda uses the following functions in particular:
"The goal was clear: to build a complete solution that could be rolled out equally at the locations in Finland, Norway and Germany," recalls the Head of QM at Yaveon. To this end, a separate system was set up in each country based on a core solution, in which country-specific adjustments were also made, but the master data was harmonized.
The very complex production processes were a challenge. Finding a suitable solution to fully map these in the ERP system was not easy. However, after a detailed analysis, various adjustments and intensive user training in production, the right path was found.
The process began in January 2010 and by October of the same year, validated ERP systems were already in use in Finland and Germany.
Ayanda continues to develop: in December 2016, the German headquarters became part of the SIRIO Group. On the market since 1993, the group specializes in the pharmaceutical and food supplement industry.
With this development, it was clear to Ayanda that an independent ERP system was needed. The company also wanted to take the opportunity to invest in a modern solution and optimize its own processes.
The project had the following objectives:
The company's development showed that it was not possible to implement ERP in the standard way. While the GAMP 5 model provides for the comparison of requirements with system functionalities, the creation of User Requirement Specifications (URS) and Functional Specifications (FS), the derivation of development needs and a GMP risk assessment, Ayanda faced a different challenge: an overall update with data conversion comprises several test phases across several releases and involves numerous iterations. The actual conversion of the data then only takes place as part of the go-live, because until then the work continues in the existing real system. It is also possible to adapt the conversion and software up to the go-live. But why?
The reason lies in the practical work: in the system to be replaced, work continues until the last second, so real (data) constellations can always change.
Together with Yaveon, Ayanda found a suitable way for the process validation: the approach follows the GAMP 5 model, and required documents such as URS and FS were already created and approved as the project progressed. Also included: risk analyses and test plans for data conversion. Functional and acceptance tests were also carried out on the validation system using test data from the current iteration status of the data conversion at that time.
However, by far the biggest changes were made in the area of adapting the legacy system: all iterations involved repeated test conversions.
Because a great deal of data had to be modified, it was not possible to describe paths and changes exactly. Inconsistencies in the data were identified immediately during each conversion process and eliminated until the conversion was successful without error messages. Tests were also carried out at each stage:
Based on the findings, Ayanda and Yaveon worked together to create an independent and formal test plan. The scope was based on the risk analysis III - i.e. 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. As up-to-date data is required for the actual go-live, the objects and required setup data could be taken from the qualified overall system.
It is important to convert all data to the current go-live.
Before the system was released, further tests were therefore carried out to ensure that the data was correct:
The definition of the respective test scope was risk-based. Based on previously defined conversion checklists, it was also confirmed that all required activities were complete and that the implementation had worked without error messages.
The system was put into operation on January 1, 2019.
Whether she is 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 - personal contact was particularly important in the initial phase. "It was very important to us that we were able to carry out the process validation ourselves. That plays a major role in the pharmaceutical industry." Ms. Duchrau also remembers many web sessions during the project. The remote work ran smoothly and saved both sides a lot of time and money.
The users at Ayanda enjoyed working with the ERP system right from the start, and further benefits have been added since the update: The system is very flexible and intuitive to use, especially in the administrative area. It is also helpful that all lists can be exported to Excel. It is now also easier to train new employees, as a profile can be created for each user in advance. They can then only see the functions that are relevant to their work area.
And what about the email from Ms. Duchrau? It was good news to reach the QM manager. Ms. Duchrau had contacted him to thank him for his excellent support and expert advice during the project. Thanks to the successfully introduced validated ERP system and the industry-specific ERP solution, Ayanda goes into every quality audit without any worries and can therefore concentrate much more on its day-to-day business.
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