Best Practices for an Effective Quality Documentation Process

Introduction

Drug development has gone through a lot of change over the past decade. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. There is always a balance between speed and compliance, while others struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. Needless to say, developing a quality and compliance posture that meets the needs of both masters (business stakeholders and auditors) is a tall order. In this piece, we will chronicle the trends that successful Quality & Compliance teams adopt to keep pace with the speed of discovery.

“If it’s not documented, it didn’t happen”

This is a well known saying to Quality teams in biotechnology. What it means is that every step in the development, clinical, and manufacturing processes needs to be documented or else regulators can’t accept that it happened. In the eyes of the FDA, without documentation, the research, the clinical trials, or the manufacturing process needs to be repeated. This results in added expense, costly delays, and an erosion in trust from regulators, investors, and consumers.