Computer Systems Validation
Software Assurance University
6th – 8th DECEMBER 2022, PHILADELPHIA, PA
With FDA’s heightened focus on Software Assurance and Data Integrity – Computer Systems Validation has taken on a new movement initiated by regulatory authorities. In fact, FDA has taken the lead with a proposed guidance on Computer Software Assurance and is asking firms to rethink their approach. With that said, the challenges remain high in our rapidly changing environment
In fact, inspectors continue to find serious findings such as – interrupted, missing, deleted and lost data, inadequate records for risk analysis, failure to exercise appropriate controls, failure to validate computer software, failure to establish validation procedures, manipulation and deletion of audit trails, and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures.
Key Industry Leaders at the Event: