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  • This procedure provides a form for creating a Computer System Project Proposal and provides directions for completing it as required byVAL002.
  • A computer System Project Proposal provides information about the system that management needs to authorize the initiation of a formal project. Information is given on the value of the system, the risks it poses, the applicability of 21 CFR Part 11 regulations, whether the system must be validated, and the magnitude of the implementation. The form is to be completed for every new system that an individual wants to bring into the organization.
  • The evaluation of the form by the system owner, IT, and QA enables the organization to determine if it wants the new systems, to fit it into the priorities for new systems, and to plan ahead for its implementation.

It Provides information on:

  • Responsibilities
  • Method
  • Quality records


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