Data Integrity

Data integrity within a CGMP environment is defined as “the assurance that data records are accurate, completed, intact, and maintained within their original context, including their relationship to other data records”. This requirement applies to paper, electronic, and hybrids of both electronic and paper records to ensure that data is reliable, true and accurate. The FDA and other regulatory agencies …

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 …

Good Clinical Practice Compliance Solutions

Practical Hands-On Experience Kymanox has a diverse body of work, practice, and professional experience – exclusively focused on the life sciences. We understand your business in a way that translates into collaborative, cost-effective solutions. We provide: • Clinical Quality Management System Development and Optimization • Clinical Compliance Gap Assessments • SOP Development, Training, and Implementation based on our KymanoxWORKS™ Good …