1.0 PURPOSE: To define a procedure for control of data integrity issues at manufacturing location. 2.0 SCOPE : 2.1 This procedure applies to all the employees working in all the departments and applicable to all GMP documents throughout its lifecycle, of …………….. 3.0 REFERENCE(S) & ATTACHMENTS 3.1 ...

1. Objective 1.1. To lay down a procedure for data integrity as part of quality management system. 1.2. To establish guidelines and procedures to ensure data integrity in regulatory activities. 1.3. To prevent unauthorized access, loss, alteration, or falsification of data throughout the regulatory processes, ...