Downloadable Resources
Downloadable Resources
- “Bridging Chasms In Equipment Qualification And Software Validation” Click here for a System Requirements Document Template for equipment qualification and software validation.
- “Developing GCP SOPs: Common Pitfalls And How To Avoid Them” Click here for a template that serves as a starting point to guide you through the process of developing clear and concise SOPs.
- “Employing GMP Techniques In GCP For More Robust, Compliant Clinical Studies” Click here to download a simple Excel spreadsheet tool that can serve as a starting point to guide you through the process of:
- Outlining critical attributes and data to obtain by using the study synopsis
- Classifying and prioritizing the risks associated with obtaining that data
- Rating the severity and likelihood of occurrence and detectability of these risks
- Developing a plan to mitigate any moderate or high-risk events
