SOP on Records Safety
1.0 Purpose: This SOP describes the guidelines for safety of records.
2.0 Scope: This SOP applies to Production and Quality Control staff.
3.0 Responsibility: Quality Control Manager to ensure that the procedure is followed.
4.0 Materials and Equipment: As required.
5.1 Data is recorded by electronic data processing systems or as hard copies.
5.2 Only authorized persons are allowed to enter or modify data in the computer.
5.3 All the changes / deletions are recorded and access is restricted by passwords or other means and the entry of critical data is independently checked.
5.4 All the records electronically stored are protected by back up transfer, paper print outs etc.
5.5 The data are readily available during the period of retention.