Apa itu Validasi?

What is Validation?

Process validation is defined as:

Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes [FDA Process Validation Guidelines, 1987].

This definition was modified by the PDA for a computerised system:

Establishing documented evidence which provides a high degree of assurance that a specific computer-related system will consistently produce a product meeting its predetermined specifications [PDA Technical Report 18, Validation of Computer-Related Systems, 1995].

The key concepts in the last definition above are:

Documented evidence;

High degree of assurance;

Predetermined specification

There are other regulatory or quality guidelines from the European Union and the Organisation for Economic Development. Each regulation may have slightly different requirements but all come down to the same series of requirements: in general, validation is concerned with generating the evidence to demonstrate that the system is fit for the purpose you use it for and continues to be so when it is operational and that there is sufficient evidence of management control. This usually means that an action must be documented. Another feature of validation is to produce an auditable system; having the appropriate documentation to aid any audit or inspection.

The problem is how to respond to the requirement for computer validation. Any response should be:

Scientifically sound

Structured

Provide adequate compliance

Reflect the way you use the application

This latter point is most important, there is no point validating a function of a system that is not used.

Equally important, is the fact that one organisation’s use of an application can be markedly different from another’s use of the same software.

Computer validation must provide confidence in the system first and foremost to management and the users, secondly to an internal quality audit and thirdly to an external inspector. Inspectors only audit an organisation on a periodic basis; all others work in the organisation and use its computerised systems daily. The users must have the confidence in a system above all others, otherwise your investment will be wasted.