FDA audit – these 8 cardinal errors happen every day!
The "FDA audit" is a controversial topic and a sword of Damocles! Who hasn't experienced it? If you manufacture and distribute products in the USA in a regulated environment that fall under the jurisdiction of the FDA (Food and Drug Administration), you're certainly confronted with this issue. There's always the latent danger of an audit by this agency. This blog post provides a very practical description of what you should do during the audit, and what you shouldn't do.
A sharp increase in findings regarding Computer System Validation (CSV) in audits: As we have announced several times, the number of findings regarding CSV in audits by designated bodies has increased in accordance with 13485:2016. Since December, Marc Holfelder, Regulatory Expert at LA2, has been contacted six times regarding major deviations on this topic. Read his blog post to learn how this happened and what approach seems advisable.
Innovation Forum Smart Technologies on March 15, 2018
LA2 GmbH presented its DOQ product in Donaueschingen and contributed the presentation "Best Practice Example of an MES Implementation in a Medium-Sized Company." Watch the video of Marc Holfelder's 15-minute presentation with concrete figures on the savings potential (starting at minute 4).
Innovation Forum Medical Technology 2017 Summary DANmed
Successfully achieving company-wide computer system validation (CSV). Minimizing the validation effort for all software systems – including the ERP system and machine connectivity – through the implementation of a regulatory-compliant MES system. In this nearly 20-minute video, the three project partners Dannoritzer Medizintechnik GmbH & Co. KG, LA2 GmbH, and CHIRON Werke GmbH & Co. KG present a pragmatic approach that addresses and addresses the challenges and issues mentioned above, and overcomes them cost-effectively and promptly! Conclusion: A significant step toward digitizing production and an important milestone in securing future business success.
What do the production of CT scanners, the manufacture of pills, and craft beer brewing have in common? This article offers an entertaining explanation of why topics like traceability and paperless production can be just as important in beer brewing as they are in the manufacture of medical technology.
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