21 CFR 211.68: Automatic, mechanical, and electronic equipment
Requires drug manufacturers to calibrate, inspect, and check automated, mechanical, and electronic equipment (including computers) under a written program with records, restrict computer record changes to authorized personnel, verify data input/output, and keep secure backups.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart D, Equipment
23%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.68, from the 483s we hold.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.Most used
Appropriate controls are not exercised over computers or related systems to assure that changes in taster production and control records or other records are instituted only by authorized personnel.211.68(b)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.211.68(a)
Cited over time
483s citing 211.68, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 211.68
- Greenwich Rx · Tomball, TexasInadequate I (6)(4) I testing on (!5) (4 ) used to sterilize diug products… Sep 9, 2026
- RC Outsourcing, LLC · Lowellville, OhioRoutine calibration, inspection and checking of automatic, mechanical and… Sep 3, 2026
- Shilpa Medicare Limited · Bengaluru, Karnataka, IndiaAppropriate controls are not exercised over computers or related systems to assure… May 29, 2026
- Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao Town, Linhai · Linhai, ChinaBackup data is not assured as exact, complete and secure from alteration, erasure… Apr 24, 2026
- PQ Pharmacy LLC · Brooksville, FloridaRecords of the inspections of automatic, mechanical or electronic equ ipment,… Apr 20, 2026
The regulation text
§ 211.68 Automatic, mechanical, and electronic equipment.
(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]
Questions
What does 21 CFR 211.68 require?
Requires drug manufacturers to calibrate, inspect, and check automated, mechanical, and electronic equipment (including computers) under a written program with records, restrict computer record changes to authorized personnel, verify data input/output, and keep secure backups.
How often is 211.68 cited in Form 483s?
It appears in about 23% of the drug-manufacturing 483s we hold from 2023 onward, which makes it one of the ten most-cited sections in those 483s.
How do FDA investigators word a 211.68 observation?
The most common opening is: “Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.”
Which sections are cited alongside 211.68?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 211.160 (General requirements), 211.67 (Equipment cleaning and maintenance).