Ensuring data quality and harmonization transforms regulatory reporting from a compliance burden into a strategic asset, enabling confident decision-making and reducing compliance costs. Leveraging ...
Opportunities lie in enhancing data integrity auditing skills within pharmaceutical manufacturing, focusing on GxP audits. Companies can capitalize by offering comprehensive training that delves into ...
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
This guide explores how regulated laboratories can achieve strong data integrity by digitalizing key processes ...
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
NEWARK, DE — QPS Holdings, LLC has implemented Oracle Argus, a widely used pharmacovigilance platform, in a move aimed at strengthening patient safety oversight and regulatory compliance across its ...
In the increasingly complex world of asset management, data integrity is paramount and underpins all facets of operations – from decision-making to regulatory compliance and investor satisfaction. As ...
ESG Steps into the Spotlight Asset Managers and the Need for First-Class ESG Data Climate Data: Complex, Confusing, Challenging A Better Way with Morningstar Ready to See for Yourself? Selecting an ...
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