Data integrity continued to be a focus of the FDA, though the reduced inspections definitely led to fewer 483s.
|Reference Number||Short Description||Long Description||2020 Frequency||2019 Frequency||2018 Frequency|
|21 CFR 211.194(a)||Complete test data included in records||Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Specifically, , ***||15||38||33|
|21 CFR 211.194(a)(4)||Complete Test Data||Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***||10||24||28|
|21 CFR 211.68(b)||Backup data not assured as exact and complete||Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems. Specifically, ***||6||6||71|
|21 CFR 211.194(a)(4)||Data secured in course of each test||Laboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product tested]. Specifically, ***||4||1||28|
|21 CFR 211.68(b)||Written record not kept of program and validation data||A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes. Specifically, ***||1||6||71|