Regulated labs face growing pressure to maintain accurate and audit-ready electronic records across an increasingly complex mix of instruments, systems, and data types. Without consistent audit trail coverage and no structured way to manage compliance findings, organizations risk FDA Form 483s, costly remediation, and significant instrument downtime. As regulatory scrutiny intensifies, labs need a practical, low-disruption solution that closes these gaps without overhauling existing workflows.
In this webinar, Instem experts demonstrate how Compliance Builder provides real-time monitoring of files, folders, databases, and applications across any Windows device, capturing every create, modify, and delete event with full metadata. You will see how the solution supports electronic signatures with dual-identifier authentication as required by 21 CFR Part 11, prevents accidental or intentional file deletions, and centralizes audit trail review across all monitored systems, all with minimal implementation effort and no disruption to current operations.
The session also introduces eQCM, Instem’s electronic Quality Control Management platform, and how it extends the value of Compliance Builder. Together, the two solutions provide end-to-end traceability from the moment a compliance gap is identified to the moment it is formally resolved.
Complete the form to access this recording and discover how Compliance Builder helps regulated laboratories strengthen data integrity, simplify audit readiness, and proactively prevent compliance findings:
