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
With version 3.04, DOQ now offers the option of signing external PDF/A documents in a regulatory-compliant manner. This means that inspection documentation outside of DOQ can be mapped paperlessly, as can CAPA processes or KV processes.
Together with the universities of Würzburg, Ulm and Regensburg, LA2 was able to contribute its regulatory and design expertise to the development of the "Corona Check" app.
Read this article to find out who was involved in the development and which regulatory influences had to be taken into account.
Every company is set up differently and has different ways of adapting to the current situation.
Read this blog post by Marc Holfelder, one of the managing directors of LA2 GmbH, on how we continue to manage our customer projects, protect employees from contagion and try to turn challenges into opportunities.
At the end of the article, he gives an overview of tips and tools for the home office.
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.
The FDA continues to tighten the reins. The American findings and warning letters continue to increase. In addition to the well-known challenges such as CAPA and Complaints, the topics of computer system validation and documentation are increasingly coming to the fore. After many years of only selective testing, the authority decided in 2010 to audit these areas much more strongly. As a consequence, this means that it will no longer be possible to deliver products to the USA in the medium to long term without implementing the legal requirements!
In this context, have you ever asked yourself how an FDA audit actually works in practice, or are you even about to have an FDA inspection?
In the 30-minute recording, Marc Holfelder, Managing Director of LA2 GmbH, talks about his experiences over the past 15 years with FDA inspections.
In 2017, the Tuttlingen-based company started to work on the introduction of DOQ. The approach was to adapt the QM system to the new DIN ISO 13485:2016 and the planned FDA 510(k) approval.
Today, the completely digital recording of all process steps in production using a tablet represents a new milestone. The enthusiasm of the own employees as well as the external presentation to customers and suppliers in consequence of the digitization shows innovation and sustainability of the company Dannoritzer.
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.
Is it still possible without Cloud?
In the medium term it often works without cloud, but in the long run the course is clearly set for cloud computing. The first reason for this is that corporate and university IT can be made more efficient and cost-effective through cloud computing. And secondly, all future technologies will be based directly or indirectly on cloud technology. Sounds like profound changes for your IT department, too. One more reason to listen to this 45-minute webinar recording.
The speakers are Marc Holfelder, Managing Director of LA2 GmbH, who has been advising MedTech companies in the areas of regulatory affairs and computer system validation for over 15 years, and Steffen Eichler, responsible for CLOUD and data center management at LA2 GmbH.
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.