Computerized systems sit at the heart of regulated development and manufacturing—from MES, LIMS, and QMS platforms to eTMF, CTMS, EDC, pharmacovigilance safety databases, and analytics tools. If these systems aren’t properly validated and controlled, every record they generate can be challenged. Data integrity citations, Form 483 observations, delayed product release, and expensive revalidation projects often trace back to weak lifecycle documentation or poorly managed vendor updates.
Evolving expectations add complexity. FDA 21 CFR Part 11, EU Annex 11, GAMP 5, global data protection rules, and emerging Computer Software Assurance (CSA) guidance are pushing organizations toward more risk-based, usage-driven validation strategies while still requiring robust controls over configuration, security, audit trails, and data retention. Add rapid SaaS release cycles and integrations across multiple data sources, and staying inspection-ready becomes a moving target.
We deploy seasoned CSV/CSA specialists—former regulators, validation engineers, and IT quality leaders—to evaluate the fitness and compliance of your GxP systems. Whether you run legacy on-prem applications, validated cloud platforms, or a mixed landscape of point solutions, we assess your validation master plan, requirements traceability, risk assessments, IQ/OQ/PQ (or verification) evidence, change control, vendor qualification, backup/restore, access management, audit trails, data migration, and interface controls. Our audits surface the issues that matter most to data integrity, product release, and submission credibility—then map them to practical, risk-based remediation steps.
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.