DSI provided a turnkey process for completing a system validation for a medical device customer working in a GLP regulated environment.
DSI provided a turnkey process for completing a system validation for a medical device customer working in a GLP regulated environment.
1 PagesCASE STUDY ©2016 Data Sciences International. The DSI logo is a trademark of Data Sciences International. Efficient JET System Validation DSI Validation Services provided a turn-key process for completing a system validation for a medical device customer working in a GLP regulated environment. The Challenge. A medical device company, with little experience using DSI technology, required validation of their JET ECG system to successfully execute a study. This particular study involved monitoring ECG data from minipigs to develop a new implantable cardiac medical device. Although the company was familiar with GLP and 21 CFR Part 11 compliance, it did not have the time or in-house experience to successfully complete a system validation. As a result, they were faced wit
