Drafting validation scripts is one of the key activities in a validation exercise designed to provide document evidence that a system performs according to its intended use. The FDA and other global agencies require objective evidence, usually in the form of screen shots that sequentially capture the target software process, to provide assurance that systems can consistently and repeatedly perform the various processes representing the intended use of the system.
Since the advent of the PC, validation engineers have been writing validation test scripts manually. The manual process of computer systems validation test script development involves capturing screenshots and pasting them into Microsoft Word test script templates. To generate screen captures, some companies use tools such as Microsoft Print Screen, TechSmith SnagIT, and other such tools. A chief complaint of many validation engineers is that the test script development process is a slow, arduous one. Some validation engineers are very reluctant to update/re-validate systems due to this manual process. So, the question posed by this blog article is simply this: “Why are you still generating test scripts manually???”
I have been conducting validation exercises for engineering and life sciences systems since the early 1980’s. I too have experienced first-hand the pain of writing test scripts manually. We developed and practice “lean validation” so I sought ways to eliminate manual, wasteful validation processes. One of the most wasteful processes in validation is the manual capture/cutting/pasting of screenshots into a Microsoft Word document.
The obvious follow up question is “how do we capture validation tests in a more automated manner to eliminate waste and create test scripts that are complete, accurate and provide the level of due diligence required for validation?”
In response to this common problem, we developed an Enterprise Validation Management system called ValidationMaster™. This system includes TestMaster™, an automated testing system that allows validation engineers to capture and execute validation test scripts in a cost-effective manner.
TestMaster™ is designed to validate ANY enterprise or desktop application. It is a browser-based system and allows test engineers to open any application on their desktop, launch TestMaster™, and capture their test scripts while sequentially executing the various commands in their applications. As the validation engineer navigates through the application, TestMaster™ captures each screenshot and text entry entered in the application.
Once the test script is saved, TestMaster™ allows the script to be published in your UNIQUE test script template with the push of a button. No more cutting/pasting screenshots from manual processes! You can generate your test scripts in MINUTES as opposed to the hours it sometimes takes to compile documents based on a series of screenshots. If you are one of those validation engineers that does not like screenshots in your scripts, you can easily create text-based processes both quickly and easily using TestMaster™.
So, what is the biggest benefit of using TestMaster™ versus manual processes? There are three key benefits which are summarized as follows:
- Automated Test Script Execution– for years, validation engineers have wanted a more automated approach for the execution of validation test scripts. ValidationMaster™ supports both hands-on or hands-off validation testing. Hands-on validation testing is the process whereby a validation engineer looks at each step of a validation test script and executes the script step-by-step by clicking through the process. Hands off validation allows a validation engineer to execute a test script with no human intervention. This type of regression testing (hands off) is very useful for cloud-based systems or systems that require more frequent testing. The validation engineer simply selects a test script and defines a date/time for its execution. At the designated time with no human intervention, the system executes the test script and reports the test results back to the system. Automated testing is here! Why are you still doing this manually?
- Traceability– TestMaster™ allows validation engineers to link each test script to a requirement or set of requirements, thus the system delivers automatic traceability which is a regulatory requirement. With the click of a button, TestMaster™ allows validation engineers to create a test script directly from a requirement. This is powerful capability that allows you to see requirements coverage through our validation dashboard on demand. This validation dashboard is viewable on a desktop or mobile device (Windows, Apple, Android).
- Test Script Execution– One of the biggest problems with manual test scripts is that they must be printed and manually routed for review and approval. Some companies who have implemented document management systems may have the ability to route the scripts around electronically for review and approval. The worst-case scenario is the company that has no electronic document management system and generates these documents manually. TestMaster™ allows validation engineers to execute test scripts online and capture test script results in an easy manner. The test script results can be captured in an automated way and published into executed test script templates quickly and easily. If incidents (bugs/anomalies) occur during testing, users have the ability to automatically capture an incident report which is tied to the exact step where the anomaly/bug occurred. Once completed, ValidationMaster™ is tightly integrated with a 21 CFR Part 11-compliant portal (ValidationMaster Portal™). Once the test script is executed, is it automatically published to the ValidationMaster™ Portal where it is routed for review/approval in the system. The ability to draft, route, review, approve, execute and post-approve validation test scripts is an important, time/cost saving feature that should be a part of any 21stcentury validation program.
- Reuse Test Scripts For Regression Testing– manual test scripts are not ‘readily’ reusable. What I mean by this is that the Word documents must be edited or even re-written for validation regression testing. Validation is not a one-time process. Regression testing is a fact of life for validation engineers. The question is, will you rewrite all of your test scripts or use automated tools to streamline the process. ValidationMaster™ allows validation engineers to create a reusable test script library. This library includes all the test scripts that make up your validation test script package. During re-validation exercises, you have the ability to reuse the same test scripts for regression testing.
Given the rapid adoption of cloud, mobile and enterprise technologies in life sciences, a new approach to validation is required. Yes, you can still conduct validation exercises on paper but why would you? In the early days of enterprise technology, we did not have tools available that would facilitate the rapid development of validation test scripts. Today, that is not the case. Systems like ValidationMaster™ are available in either a hosted or on-premise environment. These game-changing systems are revolutionizing the way validation is conducted and offering time/cost-saving features that make this process easier. So why are you still generating test scripts manually?
