According to the FDA a lot of pharmaceutical companies are struggling how to embrace the new ways of working and how adapt and implement new (digital) technologies. They have questions like:
- Should we transition to Agile way of working;
- Should we use tooling for our validation documentation;
- Should we automate our testing.
Based on my experience companies are still focusing too much on meeting regulatory requirements via heavy loaded documentation packages. Not adopting best quality practices like the new technologies and ways of working has the potential to increase risk to patients. With the current focus we focus too much on having it documented (Good Documentation Practices) and not having a safe product for our customers. The compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing, product development (both medicines and automated systems) and validation practices.
The FDA has acknowledged this struggle a few years ago and is currently focusing on Computerized System Assurance instead of Computerized System Validation. A draft version of this guideline will be available in September 2020.
With this blog I will start to give our vision on how to implement this CSA approach in the daily CSV practices. Our vision is in line with the new thoughts from the FDA and the proposed guideline.
The Rescop vision on the CSA approach will be detailed out in the following blogs which I will write in the coming months:
- Paradigm shift (less documentation more testing);
- Risk based testing;
- New testing techniques and how to capture evidence;
- Using tools;
- Vendor assessment.
Please contact us for more information via firstname.lastname@example.org