Data integrity is becoming increasingly important under cGMP regulations. Without reliable data, the quality of raw materials, in-process materials, and finished products cannot be ensured. Data integrity issues constitute both 21 CFR Part 11 and serious cGMP violations. If laboratory data integrity is compromised, products may not comply with regulatory terms or be released for sale. Regulatory agencies like the FDA have increased their focus on data integrity and reliability in recent years. Inspectors examine data based on multiple standards including cGMP, GLP, GCP, and data application integrity policies using a "guilty until proven innocent" approach.

1. DATA INTEGRITY
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Monday, April 27, 2015
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2. DATA INTEGRITY
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 Data Integrity is assuming greater
importance in cGMP’s.
 Quality of raw materials, in process
materials and finished goods can not be
assured with out data integrity.
 Data integrity issues are 21 CFR Part 11 and
severe CGMP violations.

3. DATA INTEGRITY
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 If the integrity of laboratory data is
compromised.
o Products may not comply with regulatory
authorization terms.
o Products can not be released for sale.
 In recent past FDA has Increased its focus on
data integrity and reliability.
 Similarly MHRA and Other regulatory bodies
have increased focus on data integrity.

4. DATA INTEGRITY
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 Inspectors are examining data based on
multiple regulations and standards.
o CGMP
o Good Laboratory Practices (GLP),
o Good Clinical Practices (GCP) and
o The Application Integrity Policy.

5. DATA INTEGRITY
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 “Guilty until proven innocent” approach.
 Historical approaches based on technical
justification and scientific rationale not
adequate.
 Emphasis on providing evidence that the
analytical results are not fraudulent.

6. What is DATA INTEGRITY?
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Data integrity is the assurance that data
records are accurate, complete, intact and
maintained within their original context,
including their relationship to other data
records.
This definition applies to data recorded in
electronic and paper formats or a hybrid of
both.

7. Ensuring DATA INTEGRITY:
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 Protecting original data from
 Accidental modification
 Intentional Modification
 Falsification
 Deletion

8. DATA INTEGRITY:
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 Data Integrity key to
 Reliable and trust worthy records
 Record that will withstand scrutiny during
regulatory inspections.
 According to FDA, which uses the acronym
ALCOA, data need to be “attributable,
legible, contemporaneous, original, and
accurate.”

9. Data Integrity: ALCOA
Attributable Legible
Contempora
neous Original
Accurate
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10. Revealing list of DATA INTEGRITY observation in
FDA Audits:
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 “…..trial injections…..”
 “results failing specifications are retested
until acceptable results are obtained….”
 “…..over-writing electronic raw data…..”
 “…….OOS not investigates per XYZ SOP….”
 “……appropriate controls not established…..”
“……records are not completed
contemporaneously…”
 “….observed back-date entry in logbooks.”

11. INTEGRITY issue 1:
A) This is an Integrity issue
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12. INTEGRITY issue 2:
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13. INTEGRITY as per FDA:
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14. DATA INTEGRITY:
Data integrity is the assurance that data a consistent
,accurate , reliable and accessible
Data
Assuring
Accuracy
Completeness
Consistency
Accidental-Un intentional
Unauthorized-Malicious
Generating
T
ransforming
Maintaining
Reliable
Entire life cycle
NOT
Altered
Destroyed
Modified
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15. Reasons:
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16. Reasons:
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17. EXAMPLE 2:
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18. DOUBT:
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19. DOUBT:
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20. DOUBT:
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21. DOUBT:
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22. Data Integrity Regulations:
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 FDA inspects for electronic data integrity
during the pre- and post market product
approval process.
 21 CFR Part 11 commonly referred to as
the “data integrity regulation.” Four goals
listed by FDA.
 Assess the industry’s comprehension or
continuing misinterpretations of Part
11.
 Determine how firms are ensuring the
integrity of electronic records.
 Extend scrutiny of data, quality-related
and computerized system validation-
related Form 483 inspectional
observations since 2007.

23. Electronic & Paper Data:
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 Comparisons between secure electronic data
and data in paper format
 For software compliant to 21 CFR Part
11 (9) & with appropriate technical
controls.
 Electronic data are more secure, more
difficult to manipulate or change, and
any changes are easier to detect.
 Changes to paper data, such as a
printed chromatogram, are simpler to
make, but much harder to detect.

24. Electronic & Paper Data:
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 Comparisons between secure electronic data
and data in paper format.
 Defining paper records as “raw data”
(the so-called typewriter rule) does not
satisfy the predicate rules.
 Printed paper copy of the
chromatogram will not be considered a
true copy.
 Although this comment was made
about chromatographic data, the
principles have much wider
implications.

25. Thank you very much your valuable time!
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