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Downloads Specialist articles on hot topics in the life sciences industry

Cloud 4.0 Download Expert Presentation - Computer Validation Conference 2019 Mannheim

Cloud 4.0 [Download Expert Presentation]
April 18, 2019

At the Computerized System Validation Conference 2019 in Mannheim, ARCONDIS was present with a contribution on Cloud 4.0 in the GxP‐regulated industry. You can now download the slide deck free of charge. In the presentation Sandra ... More
Blockchains in Life Sciences and Healthcare

Blockchains in Life Sciences and Healthcare — [Whitepaper]
March 20, 2019

Blockchains are set to become indispensable to the life sciences and healthcare. The technology provides an unprecedented level of supply chain transparency, it protects personal data from manipulation, and it achieves greater efficiency, lower ... More
Pharma 4.0 Download

Pharma 4.0 [Download expert presentation]
January 9, 2019

Valentino Ducati, Management Consultant Information Management, and Volker Roeder, Management Consultant Compliance, presented in June 2018 at an expert conference Pharma IT Compliance in Bonn on the topic “Pharma 4.0 | Digitalization in the ... More
Webinar Serialization downloads

Downloads webinar serialization of medicinal products
July 4, 2018

Serialization — are you ready to fulfill the new 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
Medical Device Regulation (MDR) - Webinar Downloads & Video

Webinar Downloads: Medical Device Regulation (MDR)
March 13, 2018

The new European Medical Device Regulation (MDR) was published in May 2017. There are significant changes to the Medical Device Directive impacting every major department in every company ranging from R&D to Production, Regulatory, Quality ... More
Agile Validation of Mobile Applications in the Regulated Industries

Agile Validation of Mobile Applications in the Regulated Industries
August 27, 2017

Classical approaches such as the V‐Model often do not meet the requirements of the industry 4.0 anymore. Therefore, agile project management is used more and more in software development. In his expert presentation at the IIR workshop, Thomas ... More
Data Integrity Webinar - Downloads

Data Integrity [Webinar Downloads]
May 17, 2017

In April and May 2017 ARCONDIS did a webinar series on Data Integrity in the life sciences industries (see: Why should care about Data integrity). As of now you can download the presentation and the video recording of the Data Integrity Webinar ... More
GXP cloud computing

GxP in the Cloud
July 20, 2016

In about half of German companies they are already in action – cloud solutions. By 2017, the share of cloud usage will increase to 77 percent. However, this development raises major concerns, especially in the life sciences industries, because ... More
Continued Process Validation - Change & Risk Management

Continued Process Validation — Change & Risk Management
April 5, 2016

The new Annex 15 guideline is a paradigm shift, raising questions. In the presentation of our speech at ChemAcademy’s international conference in February 2016 we intensively discuss the third and last step of the product life cycle, the ... More
IDMP Compliance – Are You Ready?

IDMP Compliance – Are You Ready? [Webinar]
February 1, 2016

With the aim of improving EU‐wide Pharmacovigilance, the IDMP compliance (Identification of Medicinal Products) implementation is mandatory by 1st of July 2016. In our webinar we address topics such as the current IDMP status, project approach ... More
International Transparency Disclosure – Quick Guide

International Transparency Disclosure – Quick Guide
February 1, 2016

Since the passage of the U.S. physician payment sunshine act (now referred to as the “Open Payments” program), we have witnessed a proliferation of similar, “look‐alike” laws, regulations and industry code requirements around the world. To help ... More
Complex Transfer Projects

Complex Transfer Projects [German Only]
February 1, 2016

Transfer projects are highly complex. Simultaneously, they become more and more important because of strategic relocations of production facilities, mergers & acquisitions, and the construction of additional production capacities. Our ... More