Ponemah Data Security

Operating within FDA 21 CFR Part 11 regulations has never been easier!

Be confident in your data with full user access control and file integrity verification. Achieve full visibility with complete system and study level audit trails.




Take Control of Your System

Secure Login

Required to work with your IT department for system configuration? Ponemah makes it easy to adhere to your IT policies using Microsoft Active Directory for Ponemah User management. Simply add domain users to the Ponemah Users or Ponemah Admin groups, then gain controlled access to the system using the same Windows login credentials you use throughout your facility.  



Electronic Records and Signatures

Each acquisition automatically creates an encrypted Electronic Signature file for 21 CFR part 11 compliance. These files are used as a unique “finger print” for verification of data file integrity. Users may attach their electronic signature and any notes related to the signing.



Controlled User Access

Does your study require unique user roles to manage different aspects of the system? Ponemah Data Security offers up to ten unique Access Levels per system. The Access Level determines the privileges granted to users of the application. Every available user function can be independently assigned or reserved. Use the simple setup dialog to construct your Access Level structure.

Once configured, assign a specific Access Level to each user. Users not assigned on a system will simply not be available from the login dialog. User may have different privileges across multiple Ponemah systems to scale based on your business needs.

Ponemah Security Access Level Setup


Ponemah Security User List Setup


Complete Confidence in Your Data

Quickly check the electronic signatures associated with saved data and verify the data have not experienced unauthorized manipulation outside of the Ponemah software. 

Easily follow the process from beginning to end. Each Ponemah login/logout and all changes to operational settings at all stages of the study will be recorded in the Audit Trail.

530 Verify Files