The purpose of a Validation Plan is to document the goals and deliverables for the software validation effort (including how to create the objective evidence). Even with the adoption of the new Computer Software Assurance (CSA) guidance and a new risk-based approach to validation, the basic elements of a strong validation plan have changed very little.

Here are some important elements to include when creating your validation plan.

• Validation Scope and Strategy – What are all the elements of the system? Does the validation include migrations and integrations?

• System Functions and their priorities – Which functions are high-risk (impacting patient safety, product quality, or data record integrity), and which are low-risk? How will you use scripted and unscripted testing?

• Training – Beyond UAT Testers, who will be trained and how (e.g., system users)?

• Deliverables – What will be included? Who will be reviewing and approving each? If it is a SaaS implementation, will the IQ and OQ come from the software vendor?

• Error handling – What will be the process? Do you have good traceability to the requirements to determine which need to be fixed prior to go live?

• SOPs, SOIs and WIs – Do you have a full list of business and IT related policies and procedures for system go live?

• System Acceptance Criteria – Who approves the system to be rolled out to production: QA? Business? Combination of both?

A well-written plan is critical to the success of a system validation effort. Ensure that you include all these elements, and you will be sure that the implementation successfully supports the needs of the business.