Quality Driven Test Management Approach supporting CSV/CSA

Quality Driven Test Management Approach supporting CSV/CSA


In GxP regulated industries we're used to be compliant with internal - and external quality requirements, incl.  legislation and guidelines, to ensure product and patient safety. We are aware of having industry good practices in place, not only regarding processes and equipment but also in relation to computerized systems. ISPE GAMP5 is the standard guide for Computerized System Validation (CSV), these days evolving towards Computerized System Approach (CSA).


To collect the required documented evidence to demonstrate that  a (changed) computerized system  is fit for intended use,  testing  is performed to confirm that the predefined specifications are met. Traditional terms are Installation Qualification followed by Operational Qualification and Performance - or Process Qualification. Used test terms are Module / Unit testing, Integration testing, Functional testing and Requirements testing.

All these "containers" emphasize a specific type of test and related activities, and are linked to a specific development phase. Unfortunately, it leaves you also with questions like:

Who is going to test, what does a test look like, what do we need to test? How far do we need to go as part of testing”? Before you know you're wondering if testing should be standardized.


Quality Driven approach

Software testing is a part of the validation activities to ensure the change to the Computerized System Landscape is fit for intended use. To ensure the required test activities are proportional, cover requirements and risks in scope and the test approach is sustainable, it's recommended to have a test framework in place.

IT related changes are developed & implemented by dedicated teams, sometimes organized as projects. Change teams (projects) are temporarily organizations, which have short term goals, are not necessarily focused on lang term effects. Lean manufacturing shows continuous improvement will lead eventually to increasing quality and decreasing costs. Choices are made beneficial to long-term effects, which can be contradictory to change team short term thinking.

Therefor a transcending (permanent) test organization is important to embed a quality-driven test approach; it consists of qualified personnel, working on test policy, test expertise, test tool policy etc. Having such a test framework makes sure that change teams use the right (efficient & effective) test strategy reducing errors and increasing confidence.


CoE - Figures



Test framework

 Every change to the computerized landscape might ask for a specific / customized approach depending on the intended purpose of the change --> "One size doesn't fit all". To tune the test strategy and related activities it's important to have a framework in place to support test professionals. Based on international standards like TMap & ISTQB our framework

  • is easy to adapt and align with surrounding (IT and business) processes and activities

  • is business driven

  • has a structure based on the different phases to control all related activities

  • comes with toolbox supporting the test process and related activities


Using this framework enables test professionals to align the test approach to purpose of the change, the identified risks, available time and budget and provides insight so that discissions can be made. During the change creation period unexpected events may affect time and budget. To be able to make the right discission how to proceed, choices in relation to quality (avoiding or excepting identified risks) must be presented to the client.



A sustainable embedded test framework not only supports the validation activities, but it also ensures a quality driven approach connected to IT and business processes. It is scalable and tunable to every desired situation and makes risk based discission making easy. Testing becomes reliable and predictable in terms of time, effort and cost.


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