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Completing a Final Validation Package in Risk Based Software Validation

Part 6: What should be included in my final validation package?

So, you’ve gone through the process and are completing the final validation package in Risk Based Software Validation. The question now is, what should be included in the final validation package? Consider the need for documentation which provides evidence that you completed your validation, records how you will use the system, and documents how you will mitigate any associated risks.Completing a Final Validation Package in Risk Based Software Validation

Your final validation package should include the following:

1. Process Mapping

  • Process maps for each critical business process identified within the facility
  • List of touch points to the critical software systems within each business process
  • User Requirements document for the software system

2. Risk Assessments

  • Risk Management Plan
  • FMEA for the software system
  • Risk Management Report for the software system

3. Functional Requirements document for the software system

4. Installation Qualification (IQ) Protocol for the software system

5. Operation Qualification (OQ) Protocol for the software system

6. IQ/OQ Execution protocols for each software system

7. Summary Report and Traceability Matrix

  • Summary Report for each software system
  • Traceability Matrix for each software system

Summary Report and Traceability Matrix

The Summary Report and Traceability Matrix are key documents. These documents will link all of the other documents together and will be the means by which you can quickly find all documentation related to each of the critical process that you have validated. Both you and any auditor that reviews your validation will find this document to be an invaluable tool in determining what documents and evidence exist and how they relate to the each process.

With the above documents, you’re now well positioned for any compliance audit that may occur. You also now have the tools for accomplishing the validation of any updates that you may need to make as you develop the use of your software, using the same Risk Based Software Validation process that you used for the initial validation – but that’s a whole new blog.

What about Performance Qualification (PQ)?

There is one document that we haven’t listed – the Performance Qualification (PQ). Why? Well, strictly speaking, at the completion of the validation, the performance qualification will not have been done. This is something that you would typically do once the system is ‘Live’. The PQ will provide you the verification that your process(es) and mitigation’s are consistently working as intended and will provide the means to document any changes that you may need to make if they aren’t. Do you have to wait until you are ‘Live’ before you do the PQ? No, you can run the PQ in your pilot environment prior to go live if you want but, since the PQ is designed really to be something that you typically complete over a period of perhaps weeks or even months, deciding to maintain your pilot environment for that length of time without going live, may not be something that you are willing to do.

In the next blog, we’ll look at what you need to consider when dealing with those pesky software updates that your vendor just loves to keep handing you.Managing Documentation within a Quality Management System E-Book_IQS

<<Read Part 5: What about Qualification Protocols and Execution?

<<Read Part 1: What is Software Validation?

Michael Heaps

Michael Heaps was born and raised just outside of Manchester, in the United Kingdom. He started his first job for a computer manufacturing company at 20 years old, after completing a year-long technical college program in Computer Sciences and has been in the Manufacturing and Quality Management Software Industry for over 30 years. In 1998, the company Heaps worked for furthered their expansion and asked him to move to the United States with his family; his wife of 28 years, daughter and son. Heaps started working with IQS, Inc. full-time in 2008 to help provide Project Management Leadership and Customer Account Management. Since then his responsibilities have grown to include: VAR Channel Support and Development, IQS Validation Services and IQS Internal Quality Assurance and Release Management. Between the close-knit working environment and interaction among customers Heaps enjoys what he does for IQS, Inc. On a personal note, Heaps enjoys reading, camping and hiking and is heavily involved in supporting the local community theatre where his wife is the Business Manager. His children are now both grown with one working in the field of law and the other an Actor/Director.

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