Still Preparing for
FDA QMSR Inspections?
Replace guesswork with real operational proof using RTLS + Digital Twin
Validate every movement, status change, and deviation with real-time controls.Replace manual controls with automated, location-based enforcement. Get secure, 21 CFR Part 11-compliant electronic records for effortless FDA traceability.
Prepare for FDA QMSR Inspections
FDA 21 CFR Part 820
ISO 13485:2016
FDA QMSR
Where Execution Breaks Under New QMSR Update?
Before your next inspection, take a quick look at how execution is enforced on your floor.
How Real-Time Data Powers Your
Quality System
Operational controls become automated, validated, and continuously synchronized with your quality system.
1
Capture
Real-Time Execution Events
RTLS tags and sensors capture precise location data for assets, WIP, and equipment across your facility.
2
Validate
System-Level Control Enforcement
Automated rules enforce segregation, release conditions, and deviation limits with secure, time-stamped validation.
3
Synchronize
QMS Integration
Seamless API integration with SAP QM, Veeva, MasterControl, and other QMS platforms.
4
Document
Inspection-Ready Evidence
Automatically generate eDHR entries, audit trails, and traceability records aligned with 21 CFR Part 11 expectations.
Would Your Records Survive a QMSR Audit?
Validate traceability and electronic record integrity before inspection.