Skip to content

Before a GMP manufacturing facility implements a software system into their operations, that system must go through a comprehensive software validation process. 

This multi-part process ensures that a manufacturing facility’s software is compliant with all FDA regulations, and all Good Manufacturing Practices (GMP) and Good Automated Manufacturing Practices (GAMP) standards. 

In addition to confirming that the system was installed correctly, the validation process also assures that the software itself is performing without error. In order to confirm that the system is performing correctly, manufacturers perform a series of tests. This crucial part of the process is known as operational qualification. 

While operational qualification is an integral part of the software validation protocol, many systems still rely on the use of a paper-based operation process. Unfortunately, this method is time-consuming and prone to human error. Or manufacturers can rely on the services of a third-party validation service to perform operational qualification. However, this option can cost up to $500,000.

To help manufacturers save time, avoid operator errors, and reduce expense, InstantGMP™ PRO, our cloud-based all-in-one manufacturing and quality system, includes built-in FDA and GMP software validation with an automated operational qualification feature. 

In the following article, we’ll explain why validation is necessary, delve into the specifics of operational qualification, highlight the benefits of InstantGMP PRO’s automated operational qualification feature, and take a closer look at GXtest, the software that helps make this automated and accurate process possible. 

Why Is FDA and GMP Software Validation Necessary?

Prior to going live in daily operations, manufacturers have to confirm that their newly installed software system is FDA-compliant, fulfills its intended purpose, and has no installation or performance issues that could adversely affect the production cycle, ingredients, materials or product.  

The software validation protocol verifies that not only is the system installed correctly, but that it is also performing optimally. It accomplishes these goals through two processes: Installation Qualification (IQ) and Operational Qualification (OQ). InstantGMP PRO’s built-in validation system performs both of these processes.

During IQ, our systems follow every step of an installation qualification document to confirm that the software was successfully installed according to all necessary system specifications, user requirements and FDA regulations. 

After performing the IQ, the validation process advances to the next phase. 

What is Operational Qualification 

After confirming that the system is installed correctly, but before it can be released for operational use, the validation process requires that manufacturers ensure that the software is functioning properly. This is called Operational Qualification (OQ). 

In a paper-based OQ process, an operator follows a script that outlines all of the steps required for each test and performs those steps manually. If the test is successful, the intended result will occur and the operator will advance to the next page of the software, follow a new script and text that respective page. 

For example, the first script may be designed to test the software’s login page. In this example, the operator follows a sequence of written steps to open the software, type in their credentials in the respective empty fields, and click the “confirm” button to ensure that this page is operating. If the expected result occurs (the login was successful) the operator advances to the next page of the software, follows the script, and performs the next text to determine if the intended result transpires.   

As you can see, this method of OQ is time-consuming and open to human error. The system may actually be operating as designed but the operator may have keyed in the wrong information or missed a step in the script. Also, the operator needs to manually record all of the results of each test in a paper document. With this method, crucial test results may be inaccurately recorded in the final document which can disrupt and delay the validation process. 

Rather than rely on this outdated, inefficient and inaccurate method, InstantGMP PRO software offers manufacturers a more effective, reliable and accurate solution: Automated Operational Qualification. 

The Benefits Of Automated Operational Qualification 

In order to make certain that our InstantGMP PRO software is operating properly after a successful installation, our built-in validation feature executes an automated operational qualification program. 

This innovative computerized testing program automatically follows 40+ test scripts to execute every keystroke, populate every empty field with the necessary information, fill out every required form, click every button, and verify every error message. 

In the event that the program encounters an error, it will alert our development team. A developer then investigates the error, establishes a solution, and corrects the defect. Then the automated operational qualification testing begins again. These tests are conducted until any and all errors are corrected and our team is completely satisfied with the results of the tests and the performance of the software system. 

As you can see, this highly efficient automated testing feature saves time, avoids operator oversights, and takes swift action to correct any identified errors. Upon completion of the automated operational qualification program.  manufacturers are presented with a detailed report that confirms all test scripts ran properly and all expected results were achieved. 

Although InstantGMP PRO software is the only system with an automated operational qualification program, this innovative feature will not be possible with the use of the equally innovative GXtest software. 

GXtest Helps Make Automated Operational Qualification Possible

From day one, our goal was to create an all-in-one manufacturing and quality system that efficiently and effectively executes all the necessary Good Manufacturing Practices processes. To achieve this goal, our developers turned to a state-of-the-art 4th generation language software to write the code for our InstantGMP PRO software: GeneXus. 

When our team began to develop our automated operational qualification program, they once again relied on GeneXus to help them make this feature possible. 

Using GXtest, GeneXus’ automated testing product, InstantGMP PRO is able to automatically run tests throughout the entire process of the software in sequence to identify errors early in the process, reduce downtime and ensure validation. 

With GXtest as part of our automated operational qualification program, manufacturers benefit from: 

  • Tests designed for CI / CD (Continuous Integration/Continuous Delivery) and in accordance with InstantGMP PRO’s exact requirements 
  • Reductions in cycle times
  • Documentation of every corresponding test and result in each stage of the software 
  • Ability to confidently release the software without issue 

Thanks to GeneXus and its GXtest product, our team is able to include this automated operational qualification program as part of InstantGMP PRO’s built-in FDA and GMP software validation feature.  

While software validation is a necessity for manufacturing facilities, it’s also a time-consuming and costly process that’s prone to human error when conducted internally or via a third party service. 

However, manufacturers can avoid these issues with InstantGMPTM PRO. Whereas other software solutions require a paper-based system, our cloud-based software includes a built-in validation feature with an automated operational qualification program that reduces expenses, production disruptions, and errors, while improving efficiency, accuracy and outcomes. 

And it does all of this in full compliance with all FDA requirements and GMP/GAMP standards. 

To learn more about InstantGMP PRO and its innovative features such as automated operational qualification, please contact our team today! 

Back To Top