Background and Challenges
The implementation of CPV in the pharmaceutical sector has become a necessary requirement within process validation by regulatory authorities (FDA, EMA). Even though manufacturers of pharmaceutical products have always implemented relevant GxP in the interest of patient safety, they are confronted with special framework, process and organizational conditions in this context:
- Complexity: The manufacture of drugs and pharmaceutical products involves a variety of processes (including manufacturing, processing, packaging, and storage) that must be monitored and verified, and between which there are interactions.
- Regulatory requirements: The pharmaceutical industry is subject to stringent regulatory requirements. CPV must be implemented in compliance with these requirements.
- Data integrity and data management: pharmaceutical companies must ensure that all data is captured, stored and transmitted correctly, completely, consistently and unalterably. The CPV solution must ensure appropriate data management systems and processes, as well as compliance with strict security and data protection standards.
- Validation: The necessary validation of analytical methods can be time-consuming and resource-intensive, as extensive testing and data comparison is required to confirm the reliability of the methods.
- Change management: changes to processes and manufacturing methods are common, whether due to optimization, product improvement, or regulatory requirements. CPV must be able to effectively manage such changes and ensure that monitored and verified process performance continues to meet requirements.
How StatSoft can help you
We guide our customers through the complexity of this task: StatSoft combines many years of expertise with CPV in the pharmaceutical sector with in-depth know-how in implementing appropriate solutions with TIBCO Data Science / Statistica software. At the same time, we provide support in discovering and harnessing the opportunities that arise in renewing processes: If processes are designed flexibly, the analytical spectrum can be significantly expanded in the future.
Together with you, we evaluate which solution is suitable and how the architecture should be designed, based on the specific conditions of your company and the concrete process requirements. In doing so, our focus is on an integrative view of the requirement, because the embedding of CPV-compliant processes always moves in the context of existing, diverse data sources and systems and processes.
The analytical software Statistica can establish connections to any data source and meets the stringent requirements of the pharmaceutical industry, so that the solutions provided can be validated with little effort.