Mit der Version 3.04 bietet DOQ nun die Möglichkeit externe PDF/A Dokumente regulatorisch korrekt zu signieren. Damit lassen sich Prüfdokumentationen außerhalb von DOQ ebenso wie CAPA Vorgänge oder KV Prozesse papierlos abbilden.
Gemeinsam mit den Universitäten Würzburg, Ulm und Regensburg konnte die LA2 ihre regulatorischen und gestalterischen Kompetenzen bei der Entwicklung der „Corona Check“ App einbringen.
Wer an der Entwicklung beteiligt war und welche regulatorischen Einflüsse berücksichtigt werden mussten lesen Sie in diesem Artikel.
Jedes Unternehmen ist anders aufgestellt und hat andere Möglichkeiten sich auf die momentane Situation einzustellen.
Lesen Sie in diesem Blog Beitrag von Marc Holfelder, einem der Geschäftsführer der LA2 GmbH, wie wir unsere Kundenprojekte weiter betreuen, Mitarbeiter vor Ansteckung schützen und versuchen Herausforderungen zu Chancen zu verändern.
Am Ende des Beitrags gibt er noch einen Überblick zu Tipps und Tools fürs Home-Office.
Wie von uns bereits mehrfach angekündigt, haben sich die Findings zum Thema CSV bei Audits von Bennanten Stellen zur 13485:2016 ausgeweitet. Seit Dezember wurde Marc Holfelder, Regulatory Expert der LA2, bereits 6x aufgrund von Hauptabweichungen zu dem Thema kontaktiert. Lesen Sie in seinem Blogbeitrag, wie es dazu kommt und welche Vorgehensweise ratsam erscheint.
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.
Marc Holfelder reports in the 30-minute webinar recording about the FDA law as well as audit examples of current findings.
In 1997, the U.S. Food and Drug Administration (FDA) enacted a law that defined the requirements for electronic data and electronic signatures for computer systems in the GMP environment - 21 CFR Part 11. What are the requirements for software systems to meet the classic 21 CFR Part 11 requirements? Why do all relevant software systems also have to be validated in the company? At the latest since the European harmonization with the FDA requirements, with the introduction of the new ISO 13485:2016 and the new MDR, the topic of validation of software systems has moved into the focus of auditors.
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.