Validation of computer systems is compulsory for customers in regulated industries.

You must be able to demonstrate that a program always processes information in a consistent, reliable and reproducible manner. The same input always produces the same output, and that the system behaves in accord with the written definition (documentation).

Validation is easier with configurable systems as the same OQ is appropriate for every system- everyone has the same source code and executables. There are no custom programs or scripts to verify.

Zumatrix offers several products and services to assist our customers with their validation activities:

IQ - As an extra part of our implementation work, we offer Installation Qualification that documents which software is loaded onto what hardware and that it has been done correctly.

OQ - Autoscribe offer test scripts that may be run against the standard test configuration of Matrix to show that the software, as installed at the customer site, performs correctly and in accord with the documentation.

PQ - Performance Qualification is required to show that the system, as finally configured, performs as described in the User Requirements documentation. Zumatrix work with several highly experienced consulting companies to provide this service, one of which is ISO-Validation Services, Inc. of Marlton, NJ. Please contact Zumatrix for further details.

Matrix Stability Express TK

As this product is a standard configuration of the Matrix Stability system, Zumatrix offer two alternative, fixed price options for validation:

  1. Full Validation Service that includes two visits to your site by a qualified specialist- the first to gather detailed information to edit the template Validation Plan, User Requirements Document, IQ Plan/Report and PQ Plan Report. The second visit is for execution of all the test scripts and production of the final reports.
  2. Expert Validation Service assumes that the customer has an existing validation system as well as sufficient qualified staff to conduct the all the services themselves. This includes:
    • Template Validation Plan and supplier "certification".
    • Template User Requirements Specification
    • Template Installation Qualification Plan/Report
    • Template Performance Qualification Protocol with Test Scripts
    • Template Validation Summary Report