PROCEDURES AND DOCUMENTATION: GETTING IT RIGHT

The Life Science industry is an ever-evolving industry which has seen amazing growth and innovation over the past two decades. One thing that has not changed within our industry is the need for quality procedures and documentation. Procedures and documentation are the foundation of how we operate and how we prove our operations are compliant. The FDA cites each year on their metrics dashboard the most frequent 483 observations. As we have examined these findings year over year, we see one set of observations that are consistent – procedures and documentation.  Numbers for the 2020 and 2021 are 75% and 69% of the observations are related to procedures and documentation. Why can’t we get those right?