The Validation of software tools used in the conduct of clinical trials is listed as a requirement described in ICH-GCP guidelines. It ensures that clinical data generated by these systems is done in a structured way, and makes sure the data created is reliable and has integrity.

Does Validation Affect You?

Is Validation required of you, or your trial software? The answer is pretty straightforward. If you are a sponsor acquiring or using software purchased through a vendor, or a company building software being used in clinical research, then you are responsible for having the correct qualification documentation. This information can be requested during audits and inspections, and absent validation documentation is a common finding.

But what is Validation, and how do you go about validating your software?

What Is Validation, And Why Is It Necessary?

Validation is the process used to check whether each step or functionality in a system fulfills its purpose and function, essentially proving that your system is performing the way it is supposed to work. Validation is vital when using the software within clinical trials, as EMA guidelines clearly state:

Failure to document and demonstrate the validated state of a computerized system is likely to pose a risk for data integrity, which may result in regulators not accepting the data within the context of a marketing authorization application.”

Sponsors are ultimately responsible for the Validation of the computerized system and for providing adequate documented evidence of the validation process during clinical trials. It is critical when using vendor software to make sure the qualification documentation is provided and to assess whether both the process and documentation are adequate. Validation is essential for all systems used within a clinical trial.

So, how do you validate your system? 

Validation In 6 Steps

Step 1: Write your validation plan

Define and document what will be validated and how to carry out the Validation of your system. It is essential to define the roles and responsibilities, as well as the acceptance criteria.

Step 2: Document your system requirements

Spend some time defining the devices and browsers that need to be taken into account for Validation. Do you know the most used operating systems and browsers in your sector?  You will need to validate your system in all operating system/ browser combinations and record these requirements in an RDD (Requirement Design Document) or URS (User Requirement Specification) document.

Step 3: Create the test script

Define how you will confirm how that function does what it is meant to do. The creation of test steps can be more complicated than you think, so be careful and precise in this part of the process.

Step 4: Execute the test steps

In this step, you perform the test steps, which are then used to confirm that the operating system meets the requirements. This phase is all about documentation.

Step 5: Write the validation report

Your Validation Summary Report provides the proof that everything you have documented in your validation plan is completed. It sums up the test results and is proof that the acceptance criteria are met.

Step 6: Maintain your validated system

Validation is not just a one time process of updating all the documents. For each new functionality that is added or test scripts, you need to document the Validation steps for these. Validation is a life long process that requires time and proper documentation.

Our Validation Insights

These are the six essential steps you need to take to validate your system, but along the way, we learned so much more about the process when validating GCP Centrals myGCP learning system ourselves.

Validating myGCP led us to realize that there are few “How To Validate” step by step instruction manuals online. There is a lot of information about why you should validate and what needs to be done, but not many step by step guides. We were fortunate enough to have a validation expert on the team, but this inspired us to share our insights and learnings in a webinar and whitepaper. We’ve made these available for everyone.

Do you need more information about the validation process, or are you interested in the process of Validation for myGCP?

Our step by step, insightful white paper shares critical information needed for completing the validation process as well as our learnings, can be downloaded here.

Interested in hearing our CEO Marieke Meulemans speak about the validation process for myGCP?  Why not sign up for the replay of our latest webinar here.