Best Practices in Preparation for an FDA Computer System Audit - March 10, 2021 - CA US
March 10, 2021 - CA US Compliance4All Phone:8004479407 Overview: As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the...
Source: lifescienceleader.com