Downloadable Resources

Downloadable Resources

  1.  “Bridging Chasms In Equipment Qualification And Software Validation”
    Click here for a System Requirements Document Template for equipment qualification and software validation.
  2. “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.
  3. “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