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Fundamentals of Computerized Systems Validation (CSV) Part 6

Design Specification

Quality Assurance - CSV - Software Validation

Following the specification of user requirements, the design specification outlines how the system will respond to those requirements. Depending on the type and complexity of the system, three different levels of design specification can be discerned.

Functional Design

The functional design describes what a system should do and what features are to be provided. The description should be comprehensible to both end users as well developers. The extent depends on the risks identified but should cover at least the user requirements. It is also typically a document which is provided by the supplier and reviewed/approved by the regulated company.

Configurational Design

Only required for systems with a certain complexity of configuration, the configurational design typically contains security parameters, setup of different roles and permissions, complex workflows and formulas.

Technical Design

A technical design is usually only required for bespoke systems that are built for a specific purpose. It typically comprises the hardware as well as the software design. The software design should include a description of the different modules/sub-systems, the interfaces between the modules and also between external systems. The amount of detail should be proportional to the risks and should be traceable to the functional design.


The design specification is an essential aspect of computer system validation. Since it is typically provided by the supplier of a system it is often not appropriately documented or even overlooked. Suppliers usually lack the expertise of working in a highly regulated quality environment. This is true for smaller, medium-sized suppliers as well as major IT service providers and big tech companies. Contact us for a free first consultation session.

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