Data integrity refers to Completeness,

Consistency and
Accuracy of data.
And this data should be,
Attributable,
Legible,
Contemporarily recorded, ALCOA
Original or true copy and 1990
ALCOA+
Accurate 2010

+
Complete, Consistent,
Endure & Available

-Harshad Suryawanshi
 Principle Meaning Reference from CFR (*not limited)

21 CFR Part 58.130(c)- Specimens shall be identified by test system, study, nature, and date of
Who recorded data: Performer/ Signer collection.
When recorded data: Date & Time (e) All data entries shall be dated on the date of entry and signed or initialed by the person
entering the data. Any change in entries shall be made so as not to obscure the original entry,
What relate: Type of data or test shall indicate the reason for such change, and shall be dated and signed or identified at the
A Attributable Where recorded: location (Ex. A. Lab) time of the change. In automated data collection systems, the individual responsible for direct
What action: Creation/Modification data input shall be identified at the time of data input. Any change in automated data entries
shall be made so as not to obscure the original entry, shall indicate the reason for change,
/Deletion shall be dated, and the responsible individual shall be identified.

21 CFR Part 58.130(e)- All data generated during the conduct of a nonclinical laboratory study,
L Legible Recorded data should be human except those that are generated by automated data collection systems, shall be recorded directly,
readable format promptly, and legibly in ink

21 CFR Part 21.100 (b)- Written production and process control procedures shall be followed in
Contemporarily Record at the same time when executed the execution of the various production and process control functions and shall be documented at
C recorded the time of performance
21 CFR Part 21.160 (a)- The requirements in this subpart shall be followed and shall be
documented at the time of performance

21 CFR Part 21.180 (d)- Records required under this part may be retained either as original
O Original Original as recorded first time without records or as true copies such as photocopies, microfilm, microfiche, or other accurate
any data loss reproductions of the original records.

21 CFR Part 58.35 (b)(6)- Review the final study report to assure that such report accurately
describes the methods and standard operating procedures, and that the reported results accurately
A Accurate Complete and free from errors, as per reflect the raw data of the nonclinical laboratory study.
GDP, verified for calculations 21 CFR Part 211.194 (a) (8) The initials or signature of a second person showing that the
original records have been reviewed for accuracy, completeness, and compliance with established
standards
21 CFR Part 211.180 (c)- All records required under this part, or copies of such records,
Available Available as per required – Internal shall be readily available for authorized inspection.
/ External inspection Records that can be immediately retrieved from another location by computer or other electronic.
means.

Enduring Data shall be store in secure manner 21 CFR 211.68 (b)-A backup file of data entered into the computer or related system shall
and unchanged during retention be maintained
+ period

21 CFR Part 211.194 (a) Laboratory records shall include complete data derived from all tests
Complete Complete as origin to recreate the necessary to assure compliance with established specifications and standards, including
event examinations and assays

Consistency in data creation with 21 CFR 58.130 (b) - The test systems shall be monitored in conformity with the protocol- this is
Consistent date & time
to verify the consistency on intended use & result generation.
21 CFR 11.10 (a) - computer systems must be validated to ensure accuracy, reliability, consistent
intended performance.

-Harshad Suryawanshi