ABSTRACT
The first phase in the project life cycle is Project Initiation. This is the responsibility of the pharmaceutical or healthcare company. It consists of five main activities that may be conducted sequentially or concurrently. These are:
• Definition of the Project Scope • Determination of the Validation Requirements • Drafting of the Validation Master Plan • Drafting of other subordinate Validation Plan(s) • Definition of the Validation Strategy
The magnitude of validation effort1 should be commensurate with the risk associated with the computer system, the computer’s dependence on software for potentially hazardous or critical functions, and the capability of the software supplier. For example, while all software modules should be validated, those modules that are critical should be subjected to a more thorough and detailed design, development, and testing. Such assurance is derived far more securely from the methodology by which the code was developed and is supported than from functional testing by the user. Likewise, size and complexity is an important factor in establishing the appropriate level of effort and associated documentation for the software. The larger the system, the more extensive procedures and management controls are required. Small and large firms alike cannot justify a superficial validation on the basis of scarce resources.
