2100 Expert Security Pack

Elevate data analysis from GMP/GLP to 21 CFR Part 11 compliance with the 2100 Expert Security Pack as an add-on to the Bioanalyzer Expert Software. Additional user management, pre-validated methods, and access control help to comply with data security, integrity and traceability requirements mandated by FDA 21 CFR Part 11.

Easily create audit trails to track and prove user actions, and manage workflows for enhanced productivity.

Note: It is mandatory to purchase the 2100 Expert SW Laptop Bundle for operation.

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Features

  • Retain complete data history and protect files from modification and deletion
  • Ensuring full data integrity.
  • Improve data security with access control that enables users to acquire and modify data files.
  • Audit trail logging user interactions, such as time, details of user interactions and security violations, ensure full traceability.
  • Pre-defined workflow management provides users with pre-set parameters and peer review cycles with electronic signatures.
  • Pre-validated methods enable 21 CF Part 11 compliance in a time and cost effective way.
  • Compliance Services (IQ and OQ) can be purchased and are delivered by a certified customer engineer who will test and verify the functionality of the system.

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