The final technical component for the DOQ MDE application is currently being developed as part of a master's thesis with the universities of Ulm and Erlangen. Pattern recognition in production orders using AI.
Read this blog post to find out how the application will work and what benefits it offers you.
In version 3.8, DOQ now offers the option of configuring the DHR for archiving. You can read about the other new features here.
"Digitization. Automation. Standardization. What if batch size 1 becomes the rule with further individualization and personalization?"
We shed light on this question in our blog post.
At the turn of 2021/2022, Ciba Vision Johor in Malaysia replaced its old SAP with the Alcon Group's new SAP-IRIS version. You can read about the phase of development until the interface to DOQ went live in the blog post by Oliver Hoff.
For some of our customers, we have provided audit support on the subject of CSV (Computer System Validation) in the course of DOQ implementation.
Read here how the audits were conducted and what specific questions were asked by the auditors. A contribution by Marc Holfelder
A summary of the presentation by Paul Kremer and Marc Holfelder from the Innovation Forum Medizintechnik in Tuttlingen on 14.10.2020
As we have already announced several times, the Findings on the subject of CSV in audits of notified bodies extended to 13485:2016. Since December, Marc Holfelder, Regulatory Expert of LA2, already contacted 6x due to main deviations on the topic. Read his blog post to find out how this happens and what course of action seems advisable.
Dannoritzer is one of the pioneers in Tuttlingen and the surrounding area when it comes to digitisation. Since the introduction of DOQ, some media have already come across this representative example of the use of Industry 4.0 in practice. Interesting are the very different reports from the daily press and trade publishers.
Read the two german articles here.
Irritating topic and Damocles sword "FDA Audit"! Who doesn't know that? At least if you manufacture products in a regulated environment and sell them in the USA that fall under the jurisdiction of the FDA (Food and Drug Administration), you will be confronted with this topic. There is a permanent latent danger that an audit of this authority is pending. What you do during the audit and what you better not do is described in this blog entry in a very practical way.
Together with UB-Software LA2 GmbH has developed an interface for the continuous data exchange between the systems. In this article you can find out which benefits you can derive from this cooperation, both in regulatory terms and in the provision of operating orders for production.
LA2 GmbH presented its product DOQ in Donaueschingen and contributed the lecture "Best Practice Example of an MES Introduction in Medium-Sized Businesses".
Watch the video of the 15-minute lecture by Marc Holfelder with concrete figures on savings potential (from minute 4). Video is in German language
This whitepaper describes the state, challenges and outlook in the field of digitization of manufacturing processes in medical technology, especially for SMEs.
This white paper clearly shows that this could result in opportunities for the future for smaller companies in medical technology.
Das sich für die kleineren Unternehmen in der Medizintechnik daraus durchaus Chancen für die Zukunft ergeben können, wird hier klar aufgezeigt.
Under this title we have published an article in the issue 06/2017 in Medizin & Technik. Here we describe how a Tuttlingen-based medical technology manufacturer used the introduction of our fully validated MES solution DOQ as the basis for adapting its quality management to the new ISO 13485:2016.
Successful for company-wide computer system validation (CSV) Minimization of the validation effort for all software systems - including ERP system and machine connection - through the introduction of a regulatory correct MES system.
In this almost 20-minute video, the three project partners Dannoritzer Medizintechnik GmbH & Co. KG, LA2 GmbH and CHIRON Werke GmbH & Co. KG, which takes up the challenges and questions mentioned above, and masters them cost-efficiently and promptly!
Conclusion: A major step towards digitizing manufacturing and an important milestone in securing future business success. Video is in German language.
What do the production of computer tomographs, the production of tablets and artisan beer brewing have in common?
This article amusingly explains why topics such as traceability and paperless production can be just as important in beer brewing as in the manufacture of medical technology.
