Good Documentation Practices

The Golden Rule: If it wasn’t documented, it didn’t happen! Good Documentation Practices (GDPs) are requirements for documenting and managing information in a Current Good Manufacturing Practice (CGMP) environment. Every employee, contractor, or guest who documents their activities on CGMP documentation must apply GDP. The FDA (Food and Drug Administration), EMA (European Medicines Agency), and other regulatory agencies inspect CGMP …

Good Writing Guidelines

Have you ever had to read a sentence two, three, or even four times to understand the point being made? If so, you know how frustrating this can be. We want to avoid this problem when writing investigation reports. What is obvious to you, as the person who experienced the unexpected event, may not be obvious to a third-party reviewer …