New Requirements for Validation of Computerized Systems Used in Clinical Trials (for trial sponsors)
June 1, 3-4:30 PM BST / 10-11:30 AM EDT
In April 2020 the EMA issued a letter announcing requirements that could be interpreted to mean that clinical trial sponsors must have full visibility on the software vendor’s specificity and testing documentation for cloud-based applications used in PV and GxP processes. Some Pistoia Alliance pharma members involved in IT Quality Assurance and Compliance anticipate that software vendors may not be prepared to provide such documentation. A roundtable discussion for trial sponsors will be held to discuss this issue and share interpretations and proposed solutions as well as experiences requesting such documentation from specific vendors.
Contact Mark Livingstone to be invited to this roundtable discussion.