CSV at Medical Devices, Systems under Two Regulations
- Technical presentations from gempex
- GAMP Conference in Mannheim on 01. December 2022
In the pharmaceutical industry, the validation of computer-based systems in order management, production, laboratory and the entire process technology has been standard for more than 30 years. In the meantime, data integrity plays a central role in inspections by authorities. New keywords such as cloud computing and artificial intelligence are taking up space, regulations and their implementation, which are described in the quasi-standard GAMP®5, are now also finding their way into the medical device industry.
With the meanwhile valid regulations in the medical technology the computer system validation (CSV) is also set as a big challenge. With the various regulatory requirements and industry standards that have thus come into force, a QA system must be implemented in accordance with 21 CFR Part 820 and/or ISO 13485, and the IT systems relevant to product quality must be validated accordingly. For this purpose, it is advisable to apply the above-mentioned quasi-industry standard of the pharmaceutical industry, GAMP®5, although this is not mandatory.
For medical devices with integrated software or, if the software even directly represents the medical device, additional requirements such as EN ISO 62304 and possibly EN IEC 82304 are relevant. The medtech companies concerned are therefore well advised to implement the requirements from both worlds in their QM system in a lean and targeted manner.
The 2nd GAMP Conference Medical Devices, which will take place on 1.12.2022 in Mannheim, is dedicated to this topic. The event offers valuable information for validation managers, quality managers and IT project managers in medical device companies. Those concerned are those who are involved in the development of new devices / instruments in research & development, who are later responsible for their operational use or who use computer-based systems for this purpose in a quality-relevant way.
Introduction Medical Devices (MD) and GAMP - Part 1
Dr. Peter Schober, Principal Consultant of gempex GmbH, will give a lecture in a team with two other speakers, which deals with the variety of topics around the processes as well as their design and the use of computerized systems. The contribution will examine the relevant standards and regulations and build a bridge to GAMP®5, the industry standard for the validation of computerized systems. Practical examples are also presented and the pitfalls that need to be avoided.
In a second presentation, the team of speakers will address the Operational Management Processes for Medical Devices. In particular, they will discuss error handling, risk assessment and evaluation and explain how to ensure good documentation. There will also be reports on trends and thus on the development of new regulations, which must be prepared for at an early stage.
Finally, the team of speakers will run through the exemplary Development of a Medical Device as a case study. In a workshop atmosphere, the respective phases are examined and the contents of the required documents and activities are highlighted. The practical application of the regualtory standards, processes and GAMP instruments will be illustrated.
The overall conference program also provides fundamental information around the lifecycle of mobile applications and at the same time also about cloud-based apps.
Further information and the possibility to register are provided by the organizer Concept Heidelberg.
The gempex team of experts will be happy to answer any questions you may have on the subject of CSV Medical Devices via contact@gempex.com.