i need detailed information on validation protocol and report .can anybody provide me the link or file .
Could you be more specific? there’s a lot of diferent kinds of validation. Diferent purposes, diferent products…
Zeeshaan,
Please forgive me if I’m not interpreting your request correctly.
Generally speaking, protocols are developed to assess how well the design meets the established requirements and specifications. Various scenarios or conditions for software operation exist, however, so the need here is to develop a robust series of tests and negative tests that ensure that the product conforms to the design specifications. You must also develop scenarios/protocols that ensure that user needs and intended uses are achieved.
High-level overview:
· Develop a series of scenarios for the uses, abuses and misuses of the software application. The more scenarios, the more robust your testing is likely to be.
· Develop test cases or protocols for the scenarios that establish input criteria and prerequisite requirements and controls (controls for the test) along with expected outcomes (predetermined acceptance criteria). Be sure that you can trace a tested parameter to a requirement in the Requirements Specifications document backwards and forwards.
· Execute the protocols using independent testers (if available) under the watchful eye of a validation engineer. Resolve issues as they occur while keeping a detailed log.
· Analyze the data gathered to ensure that the outcomes met your predetermined acceptance criteria
· Develop a summary report that states the outcome of your validation effort (pass, fail, undetermined) including your resolutions for issues found during validation. Make sure that to a degree, it mirrors the detail and validation strategy stated in your Test Plan.
As Sterile points out, there are various types of verification and validation activities, so the needs for each may be subtly or significantly different. The look and composition of the protocols could be significant as a result.
Good luck with your effort!
Regards,
Kevin
can any one me provide auto-coater and RMG performance qualification protocoal copy?
or give me parameter which required to fulfill the partial regulatory requirment.
bhavdip