Data integrity has become FDA's top enforcement priority across all regulated industries. From simple calculation errors to sophisticated data manipulation, integrity failures undermine product quality decisions and regulatory trust. FDA expects data to be attributable, legible, contemporaneous, original, accurate—plus complete, consistent, enduring, and available (ALCOA+).
Yet achieving data integrity requires more than good intentions. Legacy systems, hybrid processes, complex workflows, and human factors create vulnerabilities. Paper systems lack audit trails. Electronic systems may allow unauthorized changes. Interfaces between systems create gaps. Culture and training determine whether controls are followed.
Our data integrity auditors combine IT expertise with regulatory knowledge and behavioral insight. We evaluate technical controls, procedural disciplines, and organizational culture to identify vulnerabilities before they become violations.
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.