In Earlier post we understood What is Design Specification, Its Type & Elements in Computer System Validation.
Now in this article we are going to understand What is project validation plan(PVP) & What Content should include in PVP?.
What is Project Validation Plan(PVP):
CSV processes should be guided by a good plan that is created before the project starts. Project Validation Plan should be developed during this planning phase of the SLC
Validation plan will define the objectives of the validation, the approach for maintaining validation status over the full SDLC & satisfy all regulatory policies & industry best practices (e.g., GAMP 5).
It also defines roles and responsibilities along with the most important part, the Acceptance Criteria.
A project validation Plan shall be created to identify and define the Validation strategy and deliverable s generated as an outcome of the execution of the strategy.
The PVP should be project specific and describes the approach for the validation of the system, required activities and deliverable s
The validation plan will be created by people who have a good knowledge of the technology involved (i.e., informatics systems, instruments, devices, etc.) and serve to minimize the impact of the project on day-to-day lab processes.
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A Validation Plan should include:
- Deliverable (Documents) to be generated during the validation process
- Resources, departments & personnel to participate in the validation project
- Testing Approach – Defines the types of data that will be used for testing, along with the kind of scenarios that will be tested.
- Time-lines for completing the validation project
- Acceptance criteria to confirm that the system meets defined requirements
- Testing Team and Responsibilities – Lists the members of the validation team, along with their roles and responsibilities in the validation process.
- Compliance requirements for the system, including how the system will meet these requirements
The plan should be written with an amount of detail that reflects system complexity.
The plans should be approved, at a minimum, by the System Owner and Quality Assurance. Once approved, the plan should be retained according to your site document control procedures.
Following deliverable’s must be generated as a result of execution of these planning phase/stages-
- Project Plan (schedule)
- Change control Approval
- Updated Inventory List
- GxP Assessment & system Categorization checklist
- System level risk assessment
- Electronic Record & Electronic signature Assessment
- Vendor survey form (if applicable)
- Vendor Audit report (if applicable)
- SOW/NDA ( if applicable)
- User Requirement Specification (update if required)
- Project Validation Plan/Validation Master Plan
- Updated Inventory List
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