Audit Trail - Standard Operating Procedure

摘要

PURPOSE Describe the purpose or the intent of the audit. SCOPE Define the scope. What is the range of what you areattempting to accomplish. Out of Scope. Briefly define what is out of scope such as indicating “Non-GMP or Non-GxPsystems or equipment. RESPONSIBILITY Define the responsibilities for those involved in this audit.DEFINITIONS/ABBREVIATIONS Key definitions as indicated below Data Integrity: Completeness, consistency, andaccuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded,…