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

testXpert III, Zwick'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?"

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.

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.

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


FDA 21 CFR Part 11

FDA 21 CFR Part 11 (Code of Federal Regulations) on electronic records and electronic signatures of the United States Food and Drug Administration (FDA) defines acceptance criteria for the use of electronic records and electronic signatures in place of records in paper form and handwritten signatures on paper. These electronic documents must be handled with as much confidentiality, be just as authoritative, and hold the same value as the paper documents. Compliance with regulations such as FDA 21 CFR Part 11 and Annex 11 on EU GMP Guidelines is required for use with electronic records and signatures in a regulated environment. It is still possible to use conventional paper documents and handwritten signatures.
Testing Software testXpert III, intuitive and workflow-based

testXpert II Testing Software

Intuitive and Workflow-Based Right from the Start!

testXpert III is the result of close cooperation with software users in the materials testing industry and the experience of over 30,000 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.

Getting started is easy!

Our workflow-based software keeps training time to a minimum and makes testing efficient and reliable. The intuitive interface is identical for all Zwick materials testing machines and instruments— enabling efficient testing, from simple standard-based tests to demanding tests in research and development.
The clear, logically structured workflow guides the operator the whole way, through test preparation, execution, and results analysis, establishing a clearly identifiable visual association of all related content, ensuring fast, easy navigation. A newly structured user interface with large, expressive icons helps you navigate through the software easily so you can start testing quickly.

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