PAX-it! Extended Security Module

SKU:T-PI-ES1

Scientific imaging applications finally have a program with both the flexibility necessary to complete their imaging tasks and meet the FDA’s Part 11 requirements.

PAX-it! Extended Security imaging and software package enables you to meet the stringent compliance requirements of 21 CFR Part 11 with ease and flexibility.

This software module’s contained archival environment enables labs to satisfy 21 CFR Part 11 requirements by restricting file access and manipulation to the application itself. Perhaps the best part of this, though, is that it does so while still allowing access to its powerful processing, annotating, measurement and analysis tools. Users no longer have to sacrifice their imaging software’s capabilities for the sake of regulatory compliance.

Features include:

  • PAX-it! Extended Security requires the assignment of user accounts. User are prompted for login credentials anytime the software is launched, and requires an administrator to unlock it after three failed login attempts.
    • The ability to assign permissions ensures that users may only access actions appropriate to their role in the laboratory.
  • Files are locked at the point of digital signature, and the user’s name is permanently associated with it in addition to the date, time, status and reason for the signature. Only a logged-in user can sign images; incorrect credentials, or a different user’s credentials, are rejected.
    • Digital Signature functions can apply in different ways to secure reports according to your lab’s specific workflow.
  • PAX-it stores detailed easily-accessible audit trails logs that trace the creation, modification and deletion of files back to the users who perform those actions.
    • All information reported meets Part 11 standards, including user, action taken, date and time of the action, as well as the specific cabinet and folder it is located in.

This software package can also apply to other various imaging applications outside of microscopy.

If you’re not sure your current lab equipment and procedures are in compliance, we can help. McCrone Microscopes & Accessories and PAX-it! are uniquely positioned to provide both the experience and solutions to help you navigate the technical, optical, imaging, and practical issues you’ll need to consider and enact. You’ll need a trusted, experienced partner who has the tools to navigate this process—hit the Request a Quote button and we can begin a conversation.

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