Blog

Regulatory Trends in Computer Systems Validation and Data Integrity

Written by Gaurav Walia | Aug 29, 2022 9:00:00 AM

The Evolution of Gap Assessments, Remote Audits, Inspection Readiness and Remediation during the Covid 19 Pandemic

The Covid 19 pandemic created immense challenges for the Pharmaceutical, Biopharmaceutical and Medical Device Industries, and for companies researching, developing, and manufacturing Rx products around the world. In 2020 and 2021 (and to some degree, continuing today) all processes were dramatically impacted by the pandemic as many employees, consultants, and others were restricted from physically working in the office or manufacturing facility, resulting in skeleton crews and largely remote workers.

Critical processes throughout the development lifecycle of pharmaceutical, biotech and medical device products were required to transition from in-person to virtual procedures and processes. And of course, the virtual programs and platforms, which were available but not as widely used prior to the pandemic, required time to be developed or enhanced to a point where they could be utilized properly for the important, and highly regulated, practice of bringing a pharmaceutical or biotech drug, or medical device, to market.