Life Sciences Consulting
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Rob Stijlen
Rob Stijlen

ARCONDIS Life Sciences Consulting

Added value for life sciences in processes, IT and compliance

ARCONDIS is the largest consulting company exclusively specialized in the life science industry in Switzerland, Germany and Austria. Benefit from our unique expertise for your projects – contact us!

Our interdisciplinary teams from Basel, Frankfurt and Munich have been taking care of local and global projects in the fields of processes, IT management and compliance for medium-sized companies and global corporations in the pharma & biotech and medical devices industries as well as for agricultural, chemical & food manufacturers.

News

Webinar Serialization

Downloads of Serialization Webinar
July 4, 2018

Are you ready to fulfill the new serialization requirements? With the deadline rapidly approaching, how many of the following challenges have you successfully addressed? Implementation of a compliant IT landscape and standardized business ... More
ARCONDIS Newsletter "UPDATE" second Issue 2018

ARCONDIS Newsletter “UPDATE” – second issue 2018 published
June 21, 2018

The new UPDATE is out! In the latest issue of our newsletter, we inform our customers within the life sciences about current industry trends and topics such as: The life sciences need a new digital boost – get involved now! MDSAP – ... More
GDPR in Life Sciences and Healthcare

GDPR in Life Sciences & Healthcare
May 16, 2018

The heat is on: the two-year transition period for the new European General Data Protection Regulation GDPR / EU-DSGVO will be over on May, 25th. Where does your company stand? Compliance with GDPR requirements doesn’t have to be complex or ... More

References

Digitalization: E-Signatures in the Laboratory

Digitalization: E-Signatures in the Laboratory

Definition & implementation of relevant functions for the lab software Empower 3 CDS (chromatography) and Tiamo (titration) according to regulations and best practices to ensure data integrity. Revisioning of the user concept and creation of lean and simplified processes. Validation of new software functions and processes.

GDPR & System Frameworks

GDPR Software Readiness Check

Execution of a Fitness Check related to the new General Data Protection Regulation (GDPR) for a cloud-based customer solution platform. Identification of gaps, definition of a risk-based action plan and presentation of the results within less than one working week.

Validation Medical Device

Validation of a Medical Device

Slim and secure validation of the manufacturing process of a medical device with regard to the injection molding process and the assembly of the disposable parts of the pump. Compilation of documentation of the manufacturing process. Communication between headquarters in Switzerland and the manufacturing site in Turkey.