090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar
Harsh Thakkar, CEO of Qualtivate, explains how life sciences companies can automate quality management systems (QMS) using no-code tools like Zapier and Make to reduce manual reporting burdens. He details the regulatory framework for software validation, distinguishing between out-of-the-box, configured, and custom software categories defined in GAMP 5. Thakkar emphasizes that validation should focus on intended use and risk rather than validating the entire system, citing the FDA's Computer Software Assurance (CSA) guidance as a way to reduce documentation burdens.