Software validation plan template fdating
Performing software validation right the first time will save medical manufacturers both time and money now and in the future. Project in this context is a generic term. Plus they are easier to format and work with testing wise. Penny has helped numerous Omnify Software customers with their validation procedures with outstanding audit results.
Your initial system assessment should provide you with a list of systems which require validation. It serves to demonstrate that you understand how your system is configured for your implementation. This report should include both a summary of all the validation activities and define how the system will be managed in production.
This is a required document that can be helpful going forward when a change occurs, as it makes it easier to assess and identify where there is impact. In this case you need to review the previous validation, add new functionality, update the test cases to match current business processes, or update work instructions and re-test. Validation Plans are different than Validation Master Plans.
Many times software vendors will try to sell prepackaged validation documentation. Sometimes plans are also named for the applicable subject area, such as a Software Validation Plan. Software Validation Protocol Validation Plan This document outlines the project deliverables and responsibilities. Then either append the original test case document or add new module test cases as an attachment. These systems allow you to configure the software to meet your business needs.
Risk Analysis This document evaluates application safety and identifies potential hazards, the causes and the effect each hazard has on the application safety and use. Again, it looks like a great deal because they can show you all of these test cases that you are going to get with their packaged validation. Verification Protocol Test Plan This document defines the type of testing to be completed along with the procedures and schedules for those tests.
If it has been more than one year since the original validation, follow your change control procedure and include an assessment of other changes which may warrant full revalidation. In practice, the validation plan describes how the validation project is going to be performed.
These documents may be combined so long as you capture all of the information. If these are separate or maintained as an attachment to the Verification Protocol it makes it easier to add modules or new phases to the validation package while limiting revision time. Test Specifications Test Cases This document contains the system level test cases, based on the functional requirements set forth in the Requirements Specification. The collection of documents produced during a validation project is called a Validation Package. Again, this is when those process-based test cases pay off.
The Validation Plan is written at the start of the validation project sometimes concurrently with the user requirement specification and is usually specific to a single validation project. Network Diagram This required document provides a visual layout of how the system is configured on the network. Final Validation Report The validation report should provide a summary of all documentation associated with the validation of the software and test case results. In essence it puts a bow on the validation package.
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