How do you plan and execute computer system validation projects within budget and timeline?

Most importantly, actually try and understand what specific CSV deliverables need to be delivered, at what point in the lifecycle and by who. Be very clear on what falls under CSV scope, automation scope, and IT scope. Sounds simple but can cause so many headaches if not clearly defined.

The intended Business purpose of the software is a very crucial and most important thing to decide the scope and objective of the project. Initial assessments gives the idea of the scope and out of scope scenarios, functions, integrations and ultimately clarify the overall activities, timelines, budget, resources and so on.

In my 23 years of experience, a clearly defined and understood User Requirements Specification is the cornerstone of a successful CSV project. Without this key document, it will be difficult to identify the scope and objectives of the project, perform the risk assessment, and define the validation strategy and content of key deliverables in the project. This one document will ensure that all stakeholders are on the same page and understand the requirements to ensure the validation activities meet the intent of the project.

First best define a number system types, that need CSV. E.g. Everything with just proprietary software needs less and different tests. Smart skids with specific software written at the unique request/intrest of the single customer, needs much more validation. OS systems usually something in between but different once more. If you have these types defined, you can decide for every system what protocols/tests are needed. A tracking of doc-prep and execution is then easy...

A risk assessment is required to determine the scope of validation. Impact assessment is required to be performed as per GAMP 5 Edition 2 to determine the GAMP category. Based on the category, scope of the validation will be determined. In addition to the impact assessment, Data Integrity, ERES, and Component Criticality assessments are required. These can be merged into one or can be created separately based on the complexity of the project.

A validation plan is required to be developed on the basis of URS / UFRS and outcome of risk assessments. Guidelines and regulations like GAMP 5 edition 2 and 21 CFR 11 should be followed in creating the validation plan.

A clear and concise validation plan is critical to ensure a thorough process. While drafting the plan be sure to get all players together to ensure all needs are met. The planning starts with a comprehensive design specification (DS). Make sure the DS includes all aspects Hardware design, Hardware functionality, User requirement. Then using the GAMP requirements and the those specified in 21 CFR part 11create a traceability matrix. All of these aspects will ensure a complete and comprehensive plan.

A pre approved and pre defined Test protocol is required before tests can be executed. Protocol should cover all the criterias including worst case scenario. Test protocol should cover all the requirements that are documented in the URS. It should also be based on the risk assessments and validation plan. If tests are required to be executed in the order, it needs to defined in the test protocol. Each test should have acceptance criteria.

Review and approval stage of validation documents and test results is an important step as it determines the outcome of the validation. Therefore, it is necessary to include all the key stakeholders including an independent validation personnel (who was not involved in executing the tests), system owner and QA as a minimum. If additional reviewer and approvers are required, they can be added based on the scope of the project. This is usually captured in the validation plan.

Maintaining the validated state of the system is as important as the initial validation. It ensures that system is still performing as expected. Therefore, approved documented procedures are required to maintain validated systems. Periodic reviews should be performed based on the risk associated with the system (impact of the system). Regular audits of the system should be carried out and outcome should be clearly documented to ensure system is still operating as originally intended and data integrity is not impacted.