Reach the Ultimate Level of Data Integrity With the Sartocheck® 5 Plus
Filter integrity test values are part of the batch protocol and are used to justify the drug release. Long term reliable data is therefore crucial to avoid quality deviations and potential 483 warning letters.
Devastating malware incidents and the continuing threat of computer viruses have created an urgent need for data protection and security. The completeness, consistency and accuracy of data during its entire life-cycle are critical aspects of regulatory compliance in all systems that generate, store and retrieve data.
The integrity and security of filter integrity test data must therefore not be seen only as an IT problem but also as a potential global business risk. Low standards of data integrity & security may not only jeopardize the activities of the drug manufacturing company, but what is more critical, endanger the health of patients.
The Sartocheck® 5 Plus Filter Tester is designed in accordance with the ALCOA principles as mentioned in the FDA “Data Integrity and Compliance with Drug CGMP Questions and Answers: Guidance for Industry” from December 2018 and the ALCOA+ principles as referred to in the MHRA “GXP’ Data Integrity Guidance and Definitions” from March 2018. Additionally, the custom Linux Operating System and write-protected root file system of the Sartocheck 5 Plus, along with the unalterable data formats associated with test results and audit trail, protect against malware and virus infections, ensuring data integrity is always preserved.
Key Learning Objectives:
- Get full understanding of the importance of data integrity and data security related to filter integrity test results
- Get an insight into how the Sartocheck®️ 5 Plus Filter Tester has been designed for inherent resistance against data virus and malware
- See how the Sartocheck®️ 5 Plus Filter Tester fulfills the ALCOA+ principles
Meet Our Experts
Manager - Integrity Testing
Kirit Chatterjee is the Manager for all Integrity Testing projects in Product Development at Sartorius Stedim Biotech. He was the Technical Lead during the development of the new filter integrity tester from Sartorius Stedim Biotech. Kirit regularly interfaces with multiple internal departments as well as pharmaceutical companies to answer technical questions related to Data Integrity, QRM and Filter Integrity Testing. He started in Sartorius Stedim Biotech in August 2014 as an Electronics Engineer and has worked exclusively on the filter integrity testing.
Manager – Software – Integrity Testing
Miika Lönnqvist is the Software Manager for Integrity Testing devices at Sartorius Stedim Biotech. He is responsible for all facets of the software – developers, processes, testing, domain application, software quality, and releases. Miika holds a Bachelor’s degree in engineering in Information Technology and has extensive experience in embedded software and product development. Miika joined Sartorius Stedim Biotech in Göttingen in December 2014, and has been working exclusively on filter integrity testing.