At Veloxity Labs, quality is not a checkpoint at the end of the workflow. It is built into the operational disciplines that guide how studies are designed, executed and reported every day.
Quality in regulated bioanalysis is more than alignment with GLP, GCP and ICH M10 expectations. It depends on the operational disciplines that guide method development, data review, documentation and study oversight throughout the laboratory workflow. Routine audits, defined processes and integrated systems help protect data integrity while supporting efficient study execution. With deep regulatory experience, Veloxity’s QA function supports reliable, traceable data and informed development decisions.
Quality and data integrity in bioanalysis are shaped by the operational disciplines that guide how laboratories work every day. This report examines the practices that influence reliability, regulatory alignment and predictable timelines in modern bioanalytical laboratories, drawing on real-world experience from regulated LC-MS workflows. Explore the six disciplines that help laboratories deliver accurate, inspection-ready data while keeping development programs moving forward.
Audit-ready by design, Veloxity’s systems and processes support
transparency and traceability throughout study execution. Our proprietary VELO™ workflow system strengthens QA oversight by centralizing workflow data and helping teams identify and address issues proactively.
Explore how automated workflow data can enhance the value of QAU audits in our latest
report.
The 2025 FDA guidance on biomarker bioanalysis provides important direction while leaving questions around context of use, assay coverage and validation expectations. These areas can create uncertainty for sponsors developing novel biomarker strategies. Drawing on more than 75 years of combined experience, the Veloxity team helps sponsors interpret evolving guidance and design fit-for-purpose validation approaches.
Download the full report for practical insights on biomarker bioanalysis under the 2025 FDA
framework.
Our QA leaders actively contribute to the evolution of bioanalytical practice. In June 2024, the Center for Veterinary Medicine began accepting ICH M10 bioanalytical guidance for animal health study design, an initiative supported by Veloxity’s Chris Tudan, PhD.
Download the report to explore the transition to ICH M10 for animal health bioanalysis, the history and challenges of applicable guidance and key distinctions sponsors should understand.
High-quality bioanalysis depends on consistent operational practices across the laboratory workflow. This infographic provides a visual overview of the six disciplines discussed in our report, highlighting how these practices support data integrity, regulatory alignment and efficient study execution.
High-quality bioanalysis depends on consistent operational practices across the laboratory workflow. This brochure highlights the quality disciplines applied at Veloxity Labs to support data integrity, regulatory alignment and reliable study execution in regulated bioanalytical programs.
Planning a regulated bioanalytical study? Talk with our team about quality expectations, study design, documentation and the operational processes that support reliable, inspection-ready data.
