Modern labs rely on a wide range of instruments, workstations, databases, local drives, SharePoint sites, and legacy systems, each of which may generate or store regulated data differently. These platforms are often geographically distributed, and even individually compliant systems can create gaps in visibility, traceability, and control once data moves outside a validated application. Inspectors expect clear, credible proof that electronic records are complete, secure, attributable, traceable, and readily available for review, and reactive, manual approaches to producing that evidence increase the likelihood of delays, errors, and operational disruption.
In this white paper, Instem experts examine what inspectors are really looking for during a regulatory inspection, including the ALCOA+ principles that define data integrity, the user access and security controls examined during an inspection, and the 21 CFR Part 11 requirements around chain of custody and electronic signatures. You’ll also find a practical inspection readiness checklist covering instrument and system inventories, data lifecycle evidence, audit trail evidence, and user access and security evidence, giving quality and IT teams a clear foundation for identifying and closing gaps before inspection pressure begins.
The paper outlines why decentralized lab infrastructures create inspection risk not just within individual systems, but in the spaces around and between them, at the handoffs where data moves outside validated applications. It explores why reliance on manually pulling logs, checking folders, and reconciling inconsistent records under time pressure is inherently inefficient and risky. It also makes the case for continuous compliance, an approach where audit trails and supporting evidence are captured, organized, and accessible in real time, well before an inspector ever asks.
Complete the form to download the full white paper and learn how Compliance Builder can help your Quality and IT teams to move from reactive inspection preparation to continuous compliance across every regulated laboratory system.
