Validation of Computerized Systems (CSV)

GAMP 5 describes a validation approach according to the V-model, in which each specification phase is compared to a verification phase. In addition, categories are defined for different software systems

But there are usually considerable differences between theory and practice. In most cases, the phases can not be so clearly contrasted or separated. In particular, OQ and PQ often merge in practice into a UAT (User Acceptance Tests) phase. Therefore, it must be ensured that the processes described in the V-Modell interact effectively with each other. Also, systems can not usually be uniformly assigned to a single category, since a computer system usually consists of several hardware and software components that have to be evaluated differently.

For a commercially available system with a configuration portion, as is the case with a CDS, the validation phases given below may result.

CSV cromingo

cromingo can support, advise or take over all phases with own documents. We can discuss the form of participation together.


Validation Plan 
User Requirement Specification (URS) 

Specification Phase

In the specification phase, referring to the list of requirements, it is documented how the requirements in the system are met or implemented in concrete terms, with three different phases:

Functional Specification (FS) 
Configuration Specification (CS) 
Design Specification (CS) 
Design Review (DR) 

After completion of these phases, the system should be set up and the test cases developed (valley point in the V model). For the beginning of the test phase, a test plan should be drawn up, which shows the procedure and strategy of the test phase. Measures in the form of test cases, procedures, technical controls or staff training should be established based on a risk analysis taking into account the risk to humans, product and data. Most of the time you will take into account business-related risks. All test cases are already specified in the test plan.

Verification Phase

Installation Qualification (IQ) 
Operational Qualification (OQ) 

Note: The manufacturer often offers standardized and automated procedures for the IQ/OQ phase. It is the responsibility of the customer to evaluate and, if necessary, supplement it with appropriate in-house tests to verify the full scope of requirements and specifications. This is done in the next phase, often referred to as Performance Qualification. In the meantime, the term UAT is often used for user acceptance tests, as it is difficult to distinguish between individual phases

User Acceptance Tests/Performance Qualification (UAT/PQ) 

Conclusion and System Release

Traceability Matrix (TM) 
Validation Summary Report (VSR)