Best Practices for an Effective Quality Documentation Process

October 13, 2021

“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.

Best Practices for 21 CFR Part 11 and GxP Validation for Electronic Records

October 13, 2021

Drug development has dramatically changed over the past ten years. Specifically when it comes to GxP compliance and validation. Many biopharma companies struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. In this white paper, Egnyte will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

Best Practices Guide to Data Privacy in Clinical Trials

October 13, 2021

As life sciences companies grow, the regulatory compliance requirements and risks expand as well. These responsibilities extend beyond conventional health-related frameworks (e.g. GxP, HIPAA, etc.) into the realm of data privacy. For high-growth institutions with limited resources & bandwidth, the question arises: what should you do? In this document, Egnyte chronicles some of the regulations affecting the life sciences industry and share 5 activities to help your organization comply with these new and dynamic laws.