Software Quality Assurance for Pharma Software

by itsbusiness AG

In the pharmaceutical industry, good practices are an important way to safeguard product conformity and safety. Quality assurance is vital to ensure that the producer correctly applies good practices.

The International Society for Pharmaceutical Engineering (IPSE) is a not-for-profit association serving its members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. IPSE has defined GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems providing pragmatic and practical industry guidance.

GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner.

This guidance has the following impact on Software Quality: there has to be a Quality Management system in place which follows the prescribed processes; the Software Lifecycle Process must be followed; Quality Risk Management must be followed as part of the Life Cycle Process; and Supplier Activities must be taken into account.

GAMP 5 has software categories to provide an initial assessment as to the validation requirements / deliverables:

  • Category 1 – Infrastructure software including operating systems, Database Managers, etc.
  • Category 2 – no longer used.
  • Category 3 – Non configurable software including, commercial off the shelf software (COTS), Laboratory Instruments / Software.
  • Category 4 – Configured software including, LIMS, SCADA, DCS, CDS, etc.
  • Category 5 – Bespoke software.

Quality Management System

With our experienced consultants, itsbusiness supports you in the development of the basics for software quality assurance, carries out an assessment together with you for a TARGET/ACTUAL analysis, and submits an action plan as well as for the implementation. Within the scope of the implementation, we support you in the implementation of the action plan and ensure the achievement of the objectives.


If you have questions or need more information, please contact:

Andrew Connell
Test Automation Expert, itsbusiness AG​

+41 31 370 32 05​

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