Auditdata was faced with the challenge of finding and exchanging documents and needed a relational database solution. A solution that would both systemize documents and provide an overview of the relationships between the documents. The company chose to implement Minerva’s Medical Device PLM and Electronic PLM solutions on top of Aras, and the new solution proved to “to be close to an out-of-the-box solution in a cost that is affordable.”
Previously, the company suffered from inefficient data management along with DHF/DMR management and change control that lacked visibility and was both tedious and time-consuming. Handling all their documentation on file servers and paper – signing and scanning records – it created an inefficient and complex process, often resulting in errors and wasted time.
“We roughly had about 200.000 files on a file server. So, the biggest challenge was to find documents, obviously. Organize them manually in folders and make relationships between them was a pain. We could not search for anything. We had to do that manually,” says Dan Haugbøl, Director of Corporate QA/RA and IT/Information Security at Auditdata.
Auditdata also outsources its manufacturing. Having single files being exchanged back and forth in the supply chain was quite time-consuming, caused errors and ultimately resulted in a longer order-placement process.
“We were sending spreadsheets to the production, but there were no relationships between the files. It was a nightmare.”
Systemizing data and having an overview of the relationships between different documents are key for Auditdata. It is therefore crucial for the company to be able to align their main system with their partner’s ERP system and eliminate files “flying around.”
Aras and Medical Device PLM®, he adds, increases visibility and understanding of data relationships:
“It makes it easier for us to actually organize the Design Changes, so we can see for each design iteration which document that has been touched. The PLM system makes this process highly efficient and we can find our stuff afterwards.”
In conclusion, he states that the Minerva solution perfectly matches the needs of Auditdata.
“Medical Device is close to be an out-of-the-box solution in a cost that is affordable,” says Dan Haugbøl.
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