Compliance & Audit Management
Maintain rigorous oversight of lab activities and documentation to meet regulatory standards with ease. Compliance & Audit Management integrates seamlessly with all lab workflows, capturing detailed audit trails and ensuring that every action—whether sample testing or instrument calibration—is recorded, verified, and ready for inspection.
Benefits
Built-In Regulatory Frameworks
Align with standards like FDA 21 CFR Part 11, ISO 17025, or EU Annex 11 via pre-set compliance templates.
Automated Audit Trails
Every edit, result entry, or user login is tracked in detail, creating a secure, chronological record.
Electronic Signatures
Every edit, result entry, or user login is tracked in detail, creating a secure, chronological record.
Scheduled & On-Demand Audits
Plan regular internal audits or launch on-demand checks to verify compliance at any time.
Non-Conformance Linking
Immediately flag and address deviations by linking them to QMS modules like CAPA or Deviations for corrective actions.
Regulatory Reports
Generate pre-formatted compliance reports ready for submission to authorities or auditors.
What Sets Us Apart
Our Compliance & Audit Management module ensures that every step in your lab’s workflow meets the highest regulatory standards.
By embedding compliance checks and automated audit trails into daily operations, you minimize risks, cut audit prep time, and bolster trust in the integrity of your data and results.
Why Choose Lims?
Seamless Regulatory Compliance
Automated Audit Trails for Full Traceability
