Kneat Sponsors and Presents at KENX Computer Systems Validation & Software Assurance University 2023 in San Diego, California taking place Dec 5-7
With the 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, the 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. Kneat is excited to be a gold sponsor and to present at this event. Visit the Kneat team and meet our digital validation experts Shauna Clizbe and Samantha Morrison at our booth!
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