Documentation requirements 4.2.1 General: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 135 of 248 The quality management system documentation shall include— (a) documented statements of a quality policy and quality objectives; (b) a quality manual; (c) documented procedures required by this Schedule; (d) documents needed by the manufacturer to ensure the effective planning, operation and control of its processes; (e) records required by this Schedule, and where this Schedule specifies that a requirement, procedure, activity or special arrangement be "documented", it shall, in addition, be implemented and maintained. For each type of medical device or in vitro diagnostic medical devices, the manufacturer shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements. These documents shall define the complete manufacturing process and, if applicable, installation. The manufacture shall prepare documentation for device or in vitro diagnostic medical devices in a form of a Device Master File containing specific information as referred to in Fourth Schedule. Data may be recorded by electronic data processing systems or other reliable means, but documents and record relating to the system in use shall also be available in a hard copy to facilitate checking of the accuracy of the records. Wherever documentation is handled by electronic data processing methods, authorized persons shall enter or modify data in the computer. There shall be record of changes and deletions. Access shall be restricted by 'passwords' or other means and the result of entry of critical data shall be independently checked. Batch records electronically stored shall be protected by a suitable back-up. During the period of retention, all relevant data shall be readily available.