Nonclinical safety data must be scientifically sound and fully defensible under Good Laboratory Practice (GLP) expectations. Incomplete data trails, protocol deviations, or system suitability failures can compromise study integrity and delay development. Sponsors and test facilities alike benefit from independent eyes that understand both the science and the regulatory documentation burden.
Our GLP audit teams review study plans, raw data capture, data integrity controls, method validation, animal care and housing environments, equipment calibration/maintenance, computerized system validation, and final report reconstruction. We evaluate how effectively your quality assurance unit (QAU) functions, trace data back to source, and test whether critical processes reliably produce accurate, attributable, contemporaneous, original, and legible (ALCOA+) data.
From single-study audits to multi-site GLP facility evaluations, we tailor scope to development stage and regulatory strategy. We help close gaps through CAPA development, staff coaching, and targeted SOP updates so your nonclinical packages move forward with confidence.
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.