Support Digitalization of Processes with a smart Validation Approach
When a process is digitized with the help of a software, validation of this software is mandatory. This is required by ISO 13485 and also by the FDA in 21 CFR Part 820. However, there are significant differences in the concrete approach and the required effort, e.g. depending on the
- specific process (production vs. design control vs. document control)
- implemented software solution (off-the-shelf vs. customized software vs. in-house development)
- implementation approach (plug'n play vs. customization vs. inhouse development)?
Therefore, it is crucial to have an appropriate software validation process established that allows flexibility for the different use scenarios.
Agenda
The FDA published a new guidance for Computer Software Assurance for Production and Quality System Software recently. Jason Spiegler from Siemens, formed an FDA-Industry CSA team (FICSA) in 2016, to clarify industry misperceptions of CSV. This team has collaborated with the FDA in providing many recommendations and examples of how critical thinking can be applied in developing a risk based CSA approach, including the use of value added assurance approaches (e.g. unscripted testing) to right size the documentation burden. Many of these recommendations have been incorporated into the new FDA Draft CSA Guidance Document. He will provide background information including:
- Reason for the new guidance
- Current pain points in the industry
- The value of the risk-based assurance approach
Furthermore, Sarah Panten will speak about peculiarities in the medical technology industry and her experience in process software implementation projects:
- Risk-based approach: Assessment of risks related to the safety and performance of medical devices
- For which cases is a direct link to the risk analysis according to ISO 14971 required?
- Recommended approach for the validation of different use cases for a software such as Polarion
- Preparation of validation activities as part of the software implementation project
- The use of instructions manuals for support of validation activities
This On-Demand Webinar is relevant for people working in the medical device development.
