Data integrity is the really complex and challenging in Pharmaceutical industries.

1. DATA INTEGRITY OVERVIEW IN PHARMACEUTICAL INDUSTRY

2. 2
There can be no friendship without confidence (Trust),
and no confidence without integrity.
Transparency is the key to Trust.
Real Integrity is doing the right thing, knowing that no
body is going to know whether u did it or not.
Ethical View

3. 3
Data of Known & Document Quality
Representative, Comparable and
Complete
Defensible and Usable for its
Intended Purpose, The first time
Data With Integrity

4. 4
Expectations and Standard for Evidences
GLP requirements pertaining to Data Quality Elements,
particularly 21CFR 58.130(e) which articulates virtually all the
elements of ALCOA.

5. 5

6. 6
Complex issues in industry
Personnel integrity is a complex issue, influenced by various behavioural factors which may alter over time as a
person’s circumstances change. It is therefore important that while organisations should be able to trust the
integrity and expertise of their employees, this is no substitute for well-designed data governance systems,
robust data checking and senior management oversight.
Data integrity failure due to inadequate personnel understanding of the impact to product and patient should
be addressed by initial and on-going training. This training should also foster the correct behavioural
environment within the organisation, encouraging open reporting of errors and non-conformances without
fear of retribution.
In the event of a detected data integrity issue, the root cause(s) of failure may be identified by considering:
- What was the person’s incentive for falsifying the record? a thing that motivates or encourages someone to do
something.
- What was the person’s justification for doing so (why did they think that it was acceptable to do it)?
- How did the opportunity arise which enabled the person to falsify the record?
The situation described where ‘records are complete’ but testing may not have been performed should be
detectable by checking raw data (including metadata such as audit trails) and material reconciliation. Verification
of acceptable data governance at contractor and supplier organisations is an important aspect of data integrity
throughout the supply chain; Contract givers should include data integrity verification as part of their external
audit programme, and give a clear message regarding their expectations regarding Data Governance.

7. 7
Imp-Links
ISO/IEC 17025: Data Integrity Begins with Employee Integrity
http://www.qualitydigest.com/inside/metrology-article/isoiec-17025-data-integrity-begins-employeeintegrity.
Html
Private Labs Fake Environmental Tests
http://www.mindfully.org/Water/2003/Labs-Fake-Tests22jan03.htm
http://www2.ljworld.com/news/2002/oct/17/watertesting_lab_owner_sentenced/
Laboratory Fraud
http://enviro.blr.com/environmental-news/water/laboratory-testing/Environmental-Laboratory-Fined-9-Million-in-Fraud-/
EPA’s Integrity Policy February 2012:
http://www.epa.gov/osa/pdfs/epa_scientific_integrity_policy_20120115.pdf
Laboratory Ethics: What makes some scientist cheat?
http://www.csmonitor.com/2005/1222/p02s01-stss.html

8. 8
Todays Necessity
Laboratory Mission statements
“Ethics Statement” that all staff must sign?
Is there a policy to minimize ‘undue pressure’ on staff?
Is workload controlled to prevent ‘shortcuts
Able to differentiate Improper practices and Fraudulent activity
Quality Metrics score Card

9. 9
State of Ethics