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 …