Traceable and tamper-proof test results in the medical industry

  • Compliant with legal requirements such as 93/42/EWG or FDA 21 CFR Part 11, thereby safeguarding our customers.
  • Reliable processes and secure backups due to the creation of locally and globally comprehensive parameters, reports, and dialog boxes. This applies to multiple test programs and machines.
Medical Testing machines

Traceable manipulation-proof test results

  • Ever-increasing demands are placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions.
  • With the traceability option, testXpert III enables logging of all actions and changes before, during and after the test, making test results and the documentation traceable and protecting them from manipulation.
  • The integrated user management and functions such as electronic records and electronic signature ensure that test results are always protected from being tampered with.
  • 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.
  • ZwickRoell also offers a qualification service package (DQ/IQ/OQ) for validation support.
  • testXpert III logs all test and system related actions and settings and can therefore always answer the question

 "Who does what when why and who is responsible?“ 

Traceability testXpert III

Quick familiarization with user management

Integrated user management allows you to define different user roles or directly adopt user roles that have been defined in the Windows accounts via LDAP. 

  • testXpert III adapts to user management requirements, providing only those actions relevant to the relevant user role.
  • Users see only what is important to them so they can focus on the task at hand right from the start. 
  • User input options can be reduced to a minimum. This simplifies use and reduces familiarization time and input errors.

The example on the left shows the view optimized for the tester (activated user management with limited machine and test configuration); the example on the right shows an administrator's view with full functionalities.

Benutzerverwaltung
Benutzerverwaltung

Qualification of materials testing machines and devices

A significant element of process validation in the medical engineering and pharmaceutical industries is the technical review of individual plant and devices. This qualification is also required for ZwickRoell materials testing systems used in the medical engineering and pharmaceutical industries, because systems are subject to various legal requirements (for example, under Medical Devices Directive 93/42/EEC or regulations such as FDA 21 CFR Part 11).

ZwickRoell supports the qualification of materials testing systems in the DQ (design qualification), IQ (installation qualification), and OQ (operational qualification) processes by offering comprehensive and, if requested, individually tailored qualification documentation, as well as in the practical performance of qualification on site.

Traceability of Specimen Behavior with Video Capturing

  • Videos synchronized exactly with the test enable visual analysis of specimen behavior during testing.
  • Additional single frames from the video can be generated for interesting points in the test sequence.
  • The point of break can be repositioned after the test.
  • At the end of the test the user also has the option of visually retracing the specimen behavior.
Airbag connector testXpert III

More examples of Video Capturing

Crack propagation testXpert III
Carbon fiber prosthetic foot testXpert III

Customized Test Sequences with the Graphical Sequence Editor

The Graphical Sequence Editor gives you all the flexibility and freedom you need. It is the perfect tool for creating individual test sequences of any type, allowing you to freely combine test events, parameters and results according to your requirements.

  • Operation of the Graphical Sequence Editor is configured to your individual needs by means of drag and drop.
  • Simulation of the created test sequence ensures that the testing steps are set up logically and that the materials testing machine nor the specimens get damaged.
  • Freely programmable test sequences are a requirement, particularly in research applications. The Graphical Sequence Editor is the perfect tool for n creating non-standardized test sequences. 
Graphical Sequence Editor testXpert III
Graphical Sequence Editor module options testXpert III
Graphical Sequence Editor testXpert III
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