Why a Third-Party Informatics Consultant Should be Part of Your Cloud Strategy
Cloud computing is the 21st century’s version of the industrial revolution. In the last decade, cloud computing and associated software as a service (SaaS) products have experienced massive growth and adoption. The enormous increase in computing power accessibility that cloud technologies provide are helping to fuel a revolution in innovation and worldwide economic growth. Entire […]
What the FDA’s Quality Metrics Reporting Program Means for Your Lab
Quality metrics are utilized throughout the pharmaceutical industry to assure product quality and facilitate continued improvement of drug manufacturing processes. The FDA has also shown a significant interest in quality metrics, as data detailing compliance with quality standards in drug manufacturing helps the FDA establish compliance and inspection policies, predict and potentially mitigate future drug […]
Moving Your LIMS to the Cloud: What You Need to Know
Modern laboratories in all industries are under intense pressure to reduce costs and improve operational efficiency, while at the same time enhancing quality and maintaining regulatory compliance. Additionally, the rise of R&D externalization strategies and contract research organizations (CROs) in the pharmaceutical industry has resulted in labs collecting large amounts of data from multiple partners, […]
What the FDA Guidance on Data Integrity Means for Your Lab
Regulatory agencies worldwide are increasingly focusing their efforts on data integrity in GxP laboratories. This increased focus has led to a number of guidance documents being published on data integrity in 2016, including: The World Health Organization (WHO) published its final version of “Good Data and Records Management Practices” guidance document The European Medicines Agency […]
Tips for Using Biovia Pipeline Pilot as an Integration Platform
One of the most common integration platforms used in laboratory informatics is Pipeline Pilot from BIOVIA. Whether part of a large enterprise software implementation or a project to pass data between two applications, integration projects always present challenges. In the laboratory environment, achieving integration goes beyond merely exchanging data between applications. Laboratory equipment/automation, specialized data […]
FDA’s Guidance on Genetic Testing: What You Need to Know
In traditional medical care, diseases are typically detected via chemical changes associated with a particular condition and all patients receive a similar dose of a medication as treatment. While this one-size-fits-all approach has led to great advancements in medicine, it has by no means been successful for all patients. Over the last decade, a new […]
Scientific Computing Article – Transforming the Laboratory
Article Excerpt Featuring Astrix President & CEO; Dale Curtis The Need For Digital Transformation in the Laboratory Specialist consultancy firm Astrix Technology Group works with life science organisations to identify and implement systems for scientific informatics and laboratory operations, to maximise value from scientific data, improve product and experimental quality, and aid safety, security and […]
Dotmatics collaborates with LabVoice to enable voice assisted laboratory workflows
The integration of Dotmatics’ electronic lab notebook (ELN) with LabVoice’s scientific vocabularies and voice transcription enables capabilities to streamline R&D data capture. This game changing technology allows scientists to operate in a hands-free environment, improving workflow efficiency and data integrity. Dotmatics, a scientific informatics software and services company that is driving the automation of laboratory […]
Tips for SampleManager LIMS Instrument Integration
The following blog will detail SampleManager LIMS Instrument integration best practices and procedures to ensure success. Technological advances in laboratory instrumentation, along with higher throughput processes, have led to massive increases in the volume of analytical data. One of the main challenges faced by organizations today is turning this vast amount of data into useful […]
Designing the Unified Lab of the Future with BIOVIA ONE Lab
The need for optimizing operational efficiency while maintaining data integrity is at the core of every laboratory informatics roadmap. Innovative technologies such as BIOVIA ONE Lab, that enable digital transformation holds the key to driving process improvement and automating daily tasks within the laboratory, but the challenge lies within how to go about this effort? […]
Case Study: Cybersecurity Assessment for a Global Biopharmaceutical Company
Case Study – Overview One of the world’s leading biopharmaceutical companies, initiated an Enterprise Cyber Resiliency initiative to protect and isolate its manufacturing sites from cyber-attack and have the ability to sustain operations in light of a corporate-level attack. A key facet of the customer’s cyber resiliency approach was segmentation to establish limited, controlled sharing […]
Strategies for Surviving an FDA Audit
As part of its mission to ensure public safety, the FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. The FDA also inspects facilities that conduct clinical trials with humans and laboratories that conduct studies with animals or microorganisms when these studies are used to apply for FDA […]