Within today’s complex fields, more specifically the pharmaceutical and healthcare and food sectors, it is imperative to meet GxP standards. Determination of compliance involves an agreed set of specifications and satisfying a requirement for replicability of results, thereby making validation testing a fundamental concept in GxP operations. To ensure compliance as well as to optimize the operations of the organization, the knowledge of validation testing strategies cannot be overemphasized.

GxP validation testing therefore covers a very broad area including software and computer systems, equipment qualification validation, and process validation. The first objective is to present the documented evidence that systems and processes satisfy the requirements for the intended use and will produce desired results over and over. Not only does this rigorous approach meet the requirements of necessary regulation, but it also positively affects the final product and patient protection.

This is one of the major hurdles to be met in GxP validation testing: a vast amount and extent of tests to be conducted. When testing is done manually, then it involves various challenges including; it is slow, prone to errors, and costly. This is where innovative solutions such as Opkey appear which provides the GxP-validated testing tools in the form of the automated testing platform.

Opkey solutions make it easier for an organization to conduct validation tests within a shorter duration and with less effort compared to standard methods. Thus, testing has higher efficiency and Opkey can help to deliver products with less time-to-market, which will be valuable for every company.

A comprehensive GxP validation testing strategy should include several key elements such as:

Risk-based approach: It is recommended that testing efforts should focus on levels that have a strong likelihood of affecting the quality of the product and the safety of the patients.

Test plan development: Ensure that the test plans developed are detailed and include the following aspects, namely; objectives, scope, and acceptance criteria.

Test case design: Since the critical software is associated with a complex system and high risk, it is essential to create comprehensive test cases that address features and failures in the functionality of the system.

Test execution: Carry out tests in a routine manner with due records of the result and any variance practicing good record keeping.

Results analysis: Compare the test results to the prerequisite-defined pass/fail criteria.

Documentation: It is crucial to document any testing-related activities such as test procedures, test conclusions, and all resolutions that were made regarding the various tests carried out.

Conclusion

Regulatory compliance of GxP processes through the efficient validation of testing is a complex issue that must be methodically approached to be solved properly. It is here where Opkey delivers a breakthrough by showcasing a full-fledged solution that responds to the requirements of GxP validation testing. With the implementation of Opkey’s automation features, organizations have the opportunity to maintain compliance, while also being able to cut down on costs and time to market. Thus, within the framework of industry development, Opkey continues to evolve to become a reliable partner for businesses, ensuring the organizations are always prepared for the new requirements, defined by the legislation, as well as providing the highest quality and security of commercial operations.