§ 213.68. Automatic, mechanical, and electronic equipment.
129 words·~1 min read·
/us/cfr/t21/s§ 213.68·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Automatic, mechanical, and electronic equipment used in the manufacture, processing, packing, and holding of medical gases shall be routinely calibrated, inspected, and checked according to a written program designed to ensure proper performance. Written procedures and records of calibration, inspections, and checks shall be maintained.
(b)Computerized systems that record, store, or use data shall be appropriately validated.
(c)A backup file of data entered into the computer system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes.
(d)Appropriate change control shall be used whenever modifications are made to computer systems to assure that any changes do not adversely affect data integrity or product quality. Records of such modifications shall be maintained.