EMX Software Suite is Compliant with FDA 21 CFR Part 11

  • EMX also meets Z540, ISO 17025, and ISO 9000 Standards

EMX was built with flexibility to ensure compliancy with validation requirements. The EMX Calibration Software offers a Certified solution for any business in the Metrology and Pharmaceutical field of business.

EMX is perfect for the small to large Pharmaceutical or Medical Companies looking for a validated, compliant Maintenance and Calibration Tracking Software.

 

FDA 21 CFR Part 11

21 CFR Part 11

EMX has been validated for 21 CFR Part 11 and is compliant with the FDA's regulations for storing electronic records and regulations for electronic signatures:

  • EMX has a built in Auditing Trail and Electronic Signature option that keeps track of all changes made to Auditable records.

  • EMX has been validated and proven effective.

  • EMX integrates user friendly functionality providing real time auditing results.

 

"Our maintenance and calibration tasks are managed much better through EMX, my follow up time has been reduced so much, I am actually getting real work done!"

-Evelyn Tubbs, Cardiac Sciences

 

Get Validated and Save Time with EMXEMX Validation Protocol Template

One Red X Software, Inc has developed validation scripts for EMX to speed your company through the validation process.

  • Easy to Use Templates

  • Pre-written scripts for quicker implementation.

  • 3rd Party Validated and Compliant


 

Brief Description on how items are Audited:

Password is required before every audited item is saved.

Reason for Change is required for every audited item that is changed.

Every change is recorded in the Audit History.

Back to Top

 

Back to EMX Product Page

 

WebMaster@1RedX.com with questions or comments about this web site.
1 Red X, Inc.©