Data integrity
- 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.
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- 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