Systemvalidation   

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For validation of IT-systems, e.g. LIS and LIMS systems, by means of the Nordtest approach, assistance to initiate a project organization that will be able to solve the following tasks:

  • Dividing the computer system into manageable validate able processes.

  • Identification of the software to be validated in the individual process.

  • Prioritizing the validation effort by means of risk assessment.

  • Completing planning of the validation work.

  • Assistance to set up basically information in the life cycle model:

    • Requirements and system acceptance test specification.

    • Design and implementation information plus change control.

    • Specification of inspection and test plans.

    • Precautions against anomalies and inappropriate oddities.

    • Installation and system acceptance test.

    • Performance, maintenance, updating, servicing, and phase out.

  • Peer review and continuous follow-up on the validation efforts.

  • Code study and impartial test of programs.

  • Preparation of validation reports.

Assistance is mainly help to self-help but direct participation in the validation project work is offered as well. Software validation is offered for any type of software, purchased or self-developed programs, e.g. Excel spreadsheets and programs in C/C++, Pascal etc.

 

Copyright © 2003  Carl Erik Torp. All rights reserved.
Last updated: 20. februar 2022.