This procedure applies to electronic and hard copy GMP and cGMP documents. It applies to all activities performed in each department.
Sponsors, vendors and manufacturers are responsible for complying with this SOP except that Sponsors, vendors or manufacturers may use their document management system if available. Responsibilities will be defined in a Quality Agreement.
This procedure describes how to record and manage any raw data or documentation that is generated during the execution of the procedure. Quality department is responsible for maintaining a list of the location of any additional forms, log books, templates, data tables or copies of additional documents associated with the procedure when applicable.