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VALIDATION
The classical definition of
Validation, according to the guidelines, established by
the Food and Drug Administration in 1987, specifies
the need for “documentation which ensures that a given
process will consistently perform to the predetermined
specifications and quality standards”.
Regulations - Good Manufacturing Practices and US21
cfr§11 – require that all computer systems must be validated to satisfy the legal requirements of the pharmaceutical industry and audits carried out by the responsible persons.
Validation essentially consists in preparing standard
protocols, Installation Qualification (IQ), Operational
Qualification (OQ) and Performance
Qualification (PQ), which specify what the
system is required to do and how the required
functionality is to be tested.
If the system is developed in a series of stages
which see a step-by-step rise in the level of detail, the
system validation process follows an inverted course (the
Waterfall Model – see figure). The software and
hardware modules are first tested alone and then in more
and more complex functional combinations until the
functionality of the whole system is tested against the
original system requirements.
The Waterfall Model
The validation must demonstrate
and document the system’s compliance with all
legal requirements, as well as stating the parties
involved and specific responsibilities.
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