As we have talked about through this series, by definition, Quality Systems Validation is the action of proving, in accordance with applicable Good Practices (GxP), that any procedure, process, equipment, material, activity or system produces expected results. In application, Quality Systems encompasses Packaging and Labeling, Materials Management, Facilities and Equipment, Production, Laboratory Controls, Quality Operations and IT systems which support those functions. With all of these functional areas potentially in scope, ensuring your Quality Systems is in a state of continuous validation and, therefore, always compliant can be daunting.

Ensuring continuous compliance is an on-going activity that requires the right people, processes and supporting technologies.  However, often overlooked is the development of a long term strategy, which requires the appropriate allocation of resources and a comprehensive understanding of the state of your current Quality Systems.

Outlined below are some simple steps to follow along this journey:

1. The first step is completing an assessment of your Quality Systems. The assessment should result in a documentation of your current process flows and the gaps in your current Quality System including upgrades and changes not validated. This assessment will accurately portray your company’s Quality System strengths and areas for improvements, while also identifying areas to streamline for lean processes.
2. At this point, you will need to determine whether or not you have the right internal resources to implement your long term strategy and whether or not you may require reallocating resources or hiring external experts to start you on the path of continuous compliance.
3. Next up is gaining an understanding of the potential risks associated with the project, developing a plan to mitigate those risks and evaluating the potential cost impacts associated with the validation efforts.
4. Finally and often overlooked, after the implementation is complete, it is critical to create and document a monitoring program which should include revalidation activities and ensure that all previously validated systems remain in compliance. The sustainability of your long-term compliance strategy is dependent upon such a monitoring program.

Carefully following these steps will move your company from a reactionary stance to compliance and ensure that you are proactive in exploring all potential validation activities.

• What are the challenges your company encounters regarding validation activities?
• What resources have been the most beneficial to your company’s quality systems compliance?