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Business Analysis as the Foundation for Good Computerized System Validation
Digitalization and automation projects in a regulated environment are complex and high-stakes endeavor. The quality of business analysis (BA) performed at the outset is often the decisive factor between a smooth, compliant rollout and a costly, risk-laden project.
Read MoreSHAPTH and XWasser: Is Your Laboratory Ready for 2027?
The clock is ticking for the industry: from January 1, 2027, the use of the SHAPTH platform (Schnittstellenharmonisierung und Austauschplattform Trinkwasserhygiene) is expected to become mandatory across Germany.
Read MoreInstrument Integration in Laboratory Architecture: More Than Just an IT Project
We live in a world where plug-and-play has become the standard. Today, a new printer, a headset, or many other peripheral devices can often be integrated into existing IT environments within just a few minutes. Standard interfaces, open protocols, and interoperable systems have long been part of our everyday reality.
Read MoreLaboratory Devices Connectivity: Automation and Digital Integration
Modern life-science laboratories are increasingly adopting automation and Internet of Things (IoT) technologies, resulting in a new generation of laboratory devices equipped with smart digital features. This development enables laboratories to enhance efficiency, data management, and device coordination.
Read MoreFrom Data to Decisions: Visualising Instrument Utilisation and Reliability Across Modern Laboratories
Analytical laboratories across pharma, life sciences, food, agriculture, and water quality manage growing fleets of chromatography systems alongside other instruments.
Read MoreThe Hidden Foundation of Data Science
When life science, chemistry, and pharmaceutical companies commit to digital transformation, the focus inevitably turns to advanced analytics, actionable insights, and artificial intelligence.
Read MoreUnlocking Lab Data – The Three Pillars of FAIR Lab Data Management
High‑quality, well‑structured laboratory data is the foundation of data generated insights in R&D…
Read MoreShipping of Substances by the Compound Management
Compound management is a service hub in the pharmaceutical and biotechnology industry for the management of chemical and biological compounds used in research and development.
Read MoreThe EU AI Act – Its potential impact on the Pharma Industry
The EU AI Act is a regulation brought up by the EU in response to the boom in AI use through the world and across all industries, enabling the use of AI in a very easy and accessible manner to the General Public.
Read MoreThe IT Odyssey of a Lab Head
It all began with a seemingly straightforward request:
“We need to validate a new quality control analytical method for DNA analysis.”
Dr. D., the Lab Head, immediately thought of the DNA-Saur, an instrument stored in the basement since a previous proof-of-concept initiative. At that time, only high-level requirements had been defined, and initial steps were taken to explore the experimental setup.
Read MoreRemediation of Medical Device Design History File
This white paper addresses the issue of DHF debt and how to resolve this debt through DHF remediation. It also addresses the reasons for DHF debt and best practices for effective remediation.
Read MoreChallenges and Considerations in an ELN Evaluation and Implementation -Part.1
An Electronic Laboratory Notebook (ELN) implementation requires careful planning across multiple dimensions including strategic alignment, technical integration, and human factors.
Read MoreChallenges and Considerations in an ELN Evaluation and Implementation – Part.2
An Electronic Laboratory Notebook (ELN) implementation requires careful planning across multiple dimensions including strategic alignment, technical integration, and human factors.
Read MoreBusiness Continuity with Enterprise Chromatography Data Systems
Today, analytical laboratory methods such as chromatography are controlled via CDS within a wide range of industries and are subject to strict guidelines and regulations.
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