This is the industry's first robotically controlled motor activity validation system. The EM100 has been specially designed to help the GLP customer reach full compliance in meeting 21 CFR Part 11 validation requirements. Please contact us for full details on how you can use this system to help create a strong validation plan.

FDA Software Validation Guidance States:
“Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough. In large measure, software validation is a matter of developing a ‘level of confidence’ that the device meets all requirements and user expectations “

EM100 Photobeam Validation System
In the past simple hand movements were used to “validate” a motor activity system. Such an approach does not develop a high ‘level of confidence’ that the system is performing properly. The EM100 has been designed and validated to challenge a motor activity system with complex & predictable photobeam patterns. Additionally, these complex patterns are much more analogous to actual animal movement than the earlier methods. And the system is very simple to operate.

Easy to Use Interval Settings  Each switch setting causes specific and predictable activity patterns to be created by the robotic system; challenging fine motor, ambulations & rearing counters.  With these simple program settings the validation technician is able to create thousands of possible photobeam patterns with predictable results. Once the Validation Run has been completed, the technician compares the results recorded by the EM100 with those recorded by the activity system. If the results are not essentially equal it will indicate a validation failure.

Results Recorded/ Displayed on Front Panel