Best Practices for an Effective Quality Documentation Process
“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. In this piece, Egnyte chronicles the nine elements that successful Quality & Compliance teams adopt to keep pace with the speed of discovery. Learn the best practices for an effective quality documentation process.
Unlocking Oncology Insights - Innovations in Evidence Generation With RWE Solutions
November 15th 2023The rapid evolvement of precision oncology requires real-world data generated at a scale that unlocks insights that can not be provided from clinical trial evidence. Machine learning and large language models can be used to quickly identify information, supporting custom integrated real-world evidence solutions to make informed decisions.
