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

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.
  • Zwick Roell 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?“ 

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

The electronic records function enables you 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.

  • The report entries are saved automatically and independently from the type in the system audit trail or in the respective test programs/series.
  • The data is saved in binary coding and cannot be edited with Windows standard programs.
  • Output can be generated in "readable" form (HTML / PDF) anytime in testXpert III.
  • Report data is encoded when being archived.
  • The optional reason is automatically added to the respective report input (with the old and the modified value).
  • Comments can be inserted in the audit trail via a menu item.

Guidelines for the regulated areas of the medical and pharmaceutical industry

The regulation 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 FDA 21 CFR Part 11 and EU GMP guidelines Annex 11 on 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.

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 Zwick 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).

Zwick 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.

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