Join us for the Computer Systems Validations & Software Assurance University Conference on December 10-12, 2024 in Washington, DC

Featured Talks

Date/Time: December 12 | 1:00pm
Title: Case study: Successful Implementation of AI in GMP environment
Speaker: Loganathan Kumarasamy, Head – Informatics & Compliance Services @ Zifo

Date/Time: December 11 | 11:10am
Title: Scripted vs. Unscripted Testing – Requirements Criticality Assessment
Speaker: Vignesh Srinivas,  Manager – Compliance Services@ Zifo

Event Description
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.