ABSTRACT
This chapter explains how to perform record control and describes the role of department manager, QA Manager, and users. The responsibilities of the department manager are to create records for conducting the activities in the department, to ensure accuracy of information in the record, to file the records in the department for identifications and easy retrieval, and to inform the QA Manager whenever new records are created. The responsibilities of the QA manager are to keep a master list of all records with details from regulatory agencies. Records are maintained in the department where it was created. Department Manager ensures the integrity and safety of records within his or her responsibility. Any person requiring access to a record initially makes the request to the Department Manager responsible for managing the record. If the request is denied he or she may approach the QA Manager whose decision is final.
