Together with UB-Software, LA2 GmbH has developed an interface for continuous data exchange between the systems. This article explores the benefits you can derive from this collaboration, both in terms of regulatory compliance and in the provision of operational orders for production.

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.