Jump to the content of the page

Traceable and tamper-proof test results in accordance with FDA 21 CFR Part 11

testXpert III, ZwickRoell's new testing software, is the result of close cooperation with software users in the materials testing industry. Based on this experience, testXpert III was designed to mirror the workflows used in a test lab.

The medical and pharmaceutical industry places specific requirements on software to ensure that completed actions are traceable. testXpert III testing software offers the following tools to meet these requirements:

  • User management (LDAP) is included in the standard delivery
  • Expanded traceability in accordance with FDA 21 CFR Part 11 is an option; it includes the functions for electronic records and electronic signatures.

This combination of tools ensures that test results are protected from manipulation at all times and that modifications and test results are traceable. Together with the organizational measures and procedure instructions that apply to the individual companies themselves, the requirements of FDA in 21 CFR Part 11 are fulfilled.

User management

Integrated user management limits input access of the user. testXpert III adopts the settings defined in user management and allows each user role to access only those actions relevant to that specific role. Users see only what is important to them so they can focus on the task at hand right from the start.

Expanded traceability option

The testXpert III expanded traceability option can be used for all safety-critical tests that place special requirements on traceability and the documentation thereof. testXpert III logs all test- and system-relevant actions and settings and can always answer the question "When does who, do what, why and who is responsible?"

Tests with highest level of safety

The expanded traceability option can be configured as needed, and the degree of traceability can be defined. The administrator defines what must be logged and for which activities and events the user must enter a reason. In this manner, testXpert III offers the possibility of being individually adapted to the customer's QS regulations.

Electronic records and electronic signature function

Electronic records

The electronic records function makes it possible to comprehensively document all actions and changes carried out in the testXpert III software so that they cannot be tampered with. Users define the degree to which the actions must be logged and possibly explained in accordance with their regulatory requirements (for example, changes to a test-relevant parameter such as test speed). This data is saved in the audit trail.

Electronic signature

The electronic signature function also protects the test program/test series reliably from unwanted changes. It makes it possible to document who is assuming responsibility and at the same time, makes the audit trail paperless. The signature on the test report can be replaced by the test program/test series digital signature by entering the user name and password in the software, and it is possible to define how many people must sign and who has authorization to do so. Once signed, the test program and test series are protected from unauthorized changes.

ZwickRoell also offers a qualification service package (DQ/IQ/OQ) for validation support.

Guidelines for the regulated areas of the medical and pharmaceutical industry

testXpert III Testing Software

testXpert III is the result of close cooperation with software users in the materials testing industry and the experience of over 35,000 successful testXpert installations. From the very start, testXpert III uses a workflow that is based on your lab processes to guide you step by step through your test. Get to know testXpert III and experience how easy it is to use.