§ 211.68 Automatic, mechanical, and electronic equipment.
Cited in 1 FDA warning letterHow BatchGlow handles this
(a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.
(b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related 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. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained.
(c) Such automated equipment used for performance of operations addressed by §§ 211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11) can satisfy the requirements included in those sections relating to the performance of an operation by one person and checking by another person if such equipment is used in conformity with this section, and one person checks that the equipment properly performed the operation.
[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995; 73 FR 51932, Sept. 8, 2008]
Cited in FDA warning letters
1 of the 6 FDA warning letters in this collection (2023–2026, cosmetic and OTC manufacturers) cite this section as a violation.
- CDL Services, Inc. dba Technichem · 24 Nov 2025
violation 3: 21 CFR 211.68(b)
How BatchGlow handles this
A scale is used only while its calibration is current. BatchGlow asks for a check with a calibrated test weight before the first weighing of each shift, and a scale whose check failed is blocked until a check passes. A weight captured from the scale is refused if the reading is unstable, too old or from another device.
What it asks for, in plain words
- 21 CFR 211.68
- Automatic, mechanical and electronic equipment, computers included, is calibrated, inspected or checked under a written program, with records. In a computer system only authorized people change master and other records, input and output are checked for accuracy, and the data are backed up securely. Where some sections require one person to do a step and another to check it, such equipment doing the step and one person checking that it did it correctly is enough.
- 21 CFR 211.68(a)
- Automatic, mechanical or electronic equipment, computers included, may be used; it is then routinely calibrated, inspected or checked under a written program designed to assure proper performance, and the checks are recorded.
- 21 CFR 211.68(b)
- Controls over computer systems ensure that only authorized people change master production and control records and other records. Input and output of formulas and other data are checked for accuracy, and an exact, complete and secure backup of the data is kept.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.