Data integrity refers to the completeness, consistency, and accuracy of data. The data should follow the ALCOA principles: Attributable, Legible, Contemporaneous, Original, and Accurate. A lack of data integrity can lead to warning letters from regulators, import alerts, and no further product approvals. Typical contents of warning letters include failing to investigate complaints, falsifying documentation, and improperly recording batch information. Maintaining data integrity is important to avoid regulatory consequences.

1. Presented by
Ch. S S N D Balakrishna, M.Pharm
Dept. of Pharmaceutical Regulatory Affairs
Shri Vishnu college of pharmacy (SVCP)

2. What is Data Integrity
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Data Integrity refers to the completeness, consistency,
and accuracy of data.
The data should be ALCOA

3. ALCOA principle
ALCOA is an acronym representing the following data integrity elements:
A - Attributable
L - Legible
C - Contemporaneous
O - Original
A - Accurate
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4. “Attributable”LCOA
Clearly indicates who recorded the data or performed the activity
Signed or dated
Who wrote the document and when
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5. A “legible”coa
Clear and understandable must be possible to read or interpret data after it is
recorded
Permanent
No unexplained hieroglyphics symbols or codes
Properly corrected if required in a proper way
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6. AL“Contemporaneous”OA
Data must be recorded at the time it is generated
Close proximity to location where data generated
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7. ALC“Original”A
Data must be preserved in unaltered state
If not, it is explained as to why not
Certified copies
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8. ALCO“Accurate”
Data must correctly reflect the actions/observations made
Data checked where necessary
Modifications explained if not evident
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9. What are lead to Data integrity
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10. What are lead to Data integrity
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11. Consequence of Data Integrity
Warning letter
Import alert
No further approvals
Debarment / imprisonment –individual
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12. Typical content in Warning Letter
Failing to investigate consumer complaints.
The FDA found an operator performing in process weight
checks memorizing two " weights" , going to the next
room where the batch records are kept and documenting
The documentation is first done on loose sheets of paper
and recorded in batch record.
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13. References
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1. Under the spotlight: Data Integrity in life sciences [Internet]. Deloitte LLP. 2017. [Cited: 4 March 2020].
Available at: https://www2.deloitte.com/content/dam/Deloitte/uk/Documents/life-sciences-health-
care/deloitte-uk-data-integrity-report.pdf
2. Guideline on Data Integrity [Internet]. World Health Organisation. October 2019. [Cited: 4 March 2020].
Available
at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_819_data_integrity.pdf?
ua=1
3. FDA ALCOA Guidance [Internet]. Beckman Coulter Life Sciences. Undated. [Cited: 5 March 2020].
Available at: https://www.mybeckman.uk/resources/industry-standards/alcoa
4. [Cited: 3 March 2020]. Available at: https://www.news-medical.net/news/20190729/Data-Integrity-in-the-
Pharmaceutical-Industry.aspx
5. Data Integrity in the Pharmaceutical Industry [Internet]. News-medical.net. 29 July 2019. [Cited: 5 March
2020]. Available at: https://www.forbes.com/sites/groupthink/2015/08/30/why-your-employee-training-is-
a-waste-of-time-and-money-and-what-to-do-about-it/#788f044028cf
6. Data Integrity and Compliance With Drug CGMP: Questions and Answers Guidance for
Industry [Internet]. US Food and Drug Administration. December 2018. [Cited: 6 March 2020]. Available
at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-
compliance-drug-cgmp-questions-and-answers-guidance-industry

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Thank you