Validation Plan Template for Single System Validations (RiskVal)

• “The purpose of this Validation Plan (VP) is to define the validation approach and validation requirements for the phase-one implementation of the Electronic Document Control System.
• This Validation Plan is compliant with the requirements of VAL003 and VAL004. ”
• Provide a high level description of the major elements of the system, so that the validation approach can be determined.
• An understanding of how the system will be implemented is important to identifying the training needed during the implementation process, and may also be helpful in understanding the approach taken to the PQ.
• Contingency plans and procedures will be prepared so that the processing of the information can be performed through an alternative method if the system needs to be temporarily or permanently inactivated during the PQ.

It Provides information on:

• Responsibilities
• System definition and description
• Implementation strategy
• System maintenance and support strategy
• Training requirements related to responsibilities