Departments or individuals often bring applications into the company, or build their own using software like Access. Two types of problems result: the company is out of compliance because QA was not told and the system was not validated. In addition, the need to support a new system is sprung on IT. This procedure provides a computer system project proposal form and instructions. The form is used to assess if validation is required and the IT support needs before a new system is purchased or created. It also provides an early view into computer system implementations so that the organization can plan for the needed resources. 9 pages
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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.
