Data Integrity: Points of view from a regulator
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- Aileen Ball
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1 Data Integrity: Points of view from a regulator David Churchward, Expert GMP Inspector, MHRA UK Copenhagen, Denmark November
2 Introduction Important daily decisions regarding safety, efficacy and quality of medicines are based on data Unreliable data has become a global issue Significant barrier to providing safe and effective medicines Good data and record management has always been a requirement Ensures that data supporting decisions is complete and reliable.
3 Agenda Data Integrity: impact to patient, healthcare and industry MHRA inspection experience Benefits of good data management Developing a data integrity action plan Organisational behaviour Risk identification Technical measures.
4 Data integrity: definition The extent to which all data are complete, consistent and accurate throughout the data lifecycle. 4
5 Data integrity failure: patient and healthcare impact Safety / efficacy risks from substandard or falsified medicines Unavoidable regulatory action may lead to shortage Less effective / more expensive alternative treatments Treatment errors (unfamiliar administration regimes) No treatment.
6 Data integrity failure: industry impact Recall Regulatory actions Cost of remediation Reputational damage Loss of future business Financial impact.
7 Reputation impact on share price Company A; growth
8 Reputation impact on share price Company A; data integrity failure = share price decline Inspection
9 ????? Data integrity in the supply chain Data Integrity failure Supply chain reputational damage Shortage, poor quality medicine Health impact
10 Regulatory response Detection of data integrity failure is increasing International convergence in data integrity norms Inspectorates better equipped to: Identify data integrity failures Manage post-inspection actions and remediation plans Cooperate with other regulators Exchange information Joint inspections Coordinated market actions.
11 Inspection experience: spectrum of issues System Failure Bad Practice Wilful falsification 11
12 Benefits of good data management Reduce defects Increase process understanding Increase efficiency Quality medicines & consistent supply
13 Action plan: Good data management practices Culture Behaviour Risk identification Risk Lifecycle Governance Organisational Technical Operational Procedures, System design System surveillance Data checking Computerised system control Automation
14 Organisational behaviour and system maturity Ineffective data controls Poor decision making Learning Awareness Management understanding Policing Monitoring for failure Advanced systems System maturity Automatic good practice Unaware Basic controls 14
15 Management understanding Understand that it can happen here Not someone else s problem Being prepared to challenge the existing culture Organisational behaviour Embedded into the Pharmaceutical Quality System Senior management responsibility Open reporting culture Proportionate investigation of data integrity failure.
16 Organisational behaviours and values Leadership and empowerment Communicating realistic expectations Organisation and individuals Understanding importance of reliable data My actions impact the patient and our organisation Management trusting employees.
![Data Lifecycle Generation / recording [Disposal]](/docs-images/76/73144803/images/17-2.jpg "Processing Retrieval Reporting / checking Retention")
17 Data Lifecycle Generation / recording [Disposal] Processing Retrieval Reporting / checking Retention Decision
18 Risk Based Review Detection Risk Balance. Data impact Data Vulnerability Decision
19 Action plan: Good data management practices Culture Behaviour Risk identification Risk Lifecycle Governance Organisational Technical Operational Procedures, System design System surveillance Data checking Computerised system control Automation
20 Operational and technical measures Applicable to electronic and paper-based systems Procedures Training Data lifecycle controls Controls ensuring that ALCOA principles are achieved Technical guidance from regulators in progress.
21 Published guidance MHRA Data Integrity Guidance: MHRA Data Integrity Blog: WHO consultation on good data management practices:
22 Summary: Data integrity action plan Communicate the benefits of compliance (not just risks from non-compliance) DI compliance plan acknowledging gaps, and risk based actions to address Data lifecycle and risk management approach to implementing guidance Planning for success, not just monitoring for failure Data integrity in supply chain audit and self inspection.
23 Questions?
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