Data Reporting, Compliance and Integrity
This page provides educational resources, events, news and products related to data reporting, compliance and integrity. Content will cover aspects from how these can be achieved in a lab environment, to their importance and impact in a regulatory setting.
Data Reporting, Compliance and Integrity – Highlights
Data Integrity in Research: What Does It Mean and How Do We Achieve It?
Download this listicle to learn about the importance of data integrity in research, data integrity in the digital age and improving data integrity.
How To Guide
How To Ensure Data Integrity
Download this guide to discover how data integrity is fundamental to quality assurance, process development and production, and analytical development and quality control.
Data Integrity Non-Compliances With Chromatography Data Systems and How To Avoid Them
Over the past 10-15 years, chromatography data systems (CDS) have been at the center of data integrity issues involving data falsification, resulting in numerous FDA warning letters. In this article, we investigate the main violations cited in FDA warning letters and discuss how to avoid them.
The Latest Regulatory Guidance for Data Integrity and Regulatory Compliance
Owing to widespread data falsification and poor data management practices, data integrity and compliance with good manufacturing practice (GMP) regulations are currently a major topic in the pharmaceutical industry. To aid our understanding of data integrity concerns, regulatory authorities have issued guidance documents on the topic. This article will give an overview of this guidance and review specific requirements for computerized systems.
Data Compliance: Can Your Data Pass the Test?
Scandals that undermined the integrity of biopharmaceutical data have led regulators to clamp down on data compliance. In this infographic, we explore data compliance – what it is, why it is important and how labs and organization can make compliance easier.
The Pulse: Psychedelic News From Technology Networks Issue 2
Hello and welcome to the Pulse, the monthly psychedelics industry roundup from Technology Networks and Analytical Cannabis. Here, we’ll highlight some of the most significant psychedelic industry news from the past month, including important announcements, pre-clinical work and the latest from groundbreaking psychedelic clinical trials.
An Introduction to the Lateral Flow Test: Strengths, Limitations and Applications
Diagnostic testing is key in many areas including healthcare and preventative medicine, food safety and environmental monitoring. In this article, we will consider what lateral flow tests (LFTs) are, how they work and their applications.
Navigating GDPR Guidelines in Decentralized Trials
This article explores how sponsors can overcome some of the challenges of data privacy when conducting decentralized clinical trials.
EU Regulations Fall Short Over Environmental Emission of Pharmaceutical Manufacturing Waste
EU regulation pertaining to good manufacturing practices and environmental risk assessment of pharmaceuticals does not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains, a recent study concludes.
Pistoia Alliance Launches Pharma Innovation Council and Appoints New Chief Portfolio Officer
The Pistoia Alliance has launched the Pistoia Alliance Pharma Innovation Council. The Council will seed ideas for new pre-competitive projects aligned with the Alliance’s strategic themes: Emerging sciences and Technology, Improving the Efficiency and Effectiveness of R&D and Empowering the Patient.
Cutting Edge Technology for Vascularized Kidney Organoids
AMSBIO has published an interview with Professor Ryuji Morizane, a renowned expert in renal research at Harvard Medical School.
Updated Air Monitoring Requirements for Medical Device Manufacturers
The EU GMP Annex 1 provides specific guidance on the manufacture of sterile medicinal products. Though it is a European guide for manufacturing, EU GMP Annex 1’s impact is global. So how does the latest revision affect you?