adesso BLOG

If a piece of software is designed by the vendor for therapeutic or diagnostic purposes, it is regarded as a medical device under the law. That means that the manufacturer must comply with all applicable laws and hence all guidelines set out in the different standards there are. In my blog post, I will describe how the expectations described in the standards and regulations can be presented and grouped to ensure it is possible to examine and document them as part of a larger overall process.

Working on and supporting projects in the life sciences sector means dealing with a whole host of regulatory requirements. In this blog post, I will provide an overview of which standards, regulations, laws and guidelines might be involved and what impact they have on project management.

Laboratories are working hard today to solve the problems created by the exponential increase in data. One promising approach is single source of truth (SSOT). In this blog post, I will explain the underlying concept behind SSOT as well as the advantages it brings.

The era of digitalisation has seen the amount of data available increase exponentially. That is why good communication between instances is still the key to managing it – and data standards play a major role in this. This blog post will explain which challenges data standards can solve.

Since work to redesign laboratories is already underway these days, it can be assumed that in ten years, the laboratories of the future will look much different than they do now. But how might they look? In my blog post, I will use the example of a fictitious scientist named Alva to describe the day-to-day work in a laboratory in the year 2033.

The path to successful digitalisation in the laboratory requires the use of IT systems. While a large part of the documentation and data volume for manual process steps is kept on paper, an increased level of digitalisation also entails an increased volume of data. This makes it all the more important to ensure that the IT systems that are used are validated so that the data that’s generated and processed is subject to the required quality criteria.