Moving Beyond Paper-based Validation – An Industry Transformation
Author – Bryan Ennis, Co-Founder & CEO, BTR
Over the last 10 years, the majority of life sciences organizations have successfully transitioned their regulated systems into the cloud, and almost all new companies are entirely cloud-based from the start.
As technology proliferates across business units, the volume of validation work is increasing exponentially.
This challenge is amplified by a global staffing shortage, including validation experts. Historically, these resources have followed the industry practice of Computer System Validation (CSV), which is paper-driven, largely manual, and resource intensive.
Regulators have acknowledged the cost and resource burden CSV is causing the industry, and are encouraging a transition to Computer Software Assurance (CSA) to help organizations improve product quality, product safety and patient safety. This transition provides a path away from time- and personnel-intensive, burdensome validation to a risk-based, digital, structured, workflow-driven process that preserves data integrity.
Learn how to assess your current state, build a team to embrace change, simultaneously update processes and technology, and scale and measure enterprise-wide performance.