Post on 17-Aug-2015
System & Processes Sw
apan B
andyopadhyay
Data is the proof of evidence that we did it
as per guidelines and submitted-filings.
Data integrity must be maintained
across the entire process of business.
data is generated out of;
People
Processes
Computerized systems
Communications
What is “DATA” B
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Why “Data Integrity” ?
• To have evidence that the work has been done in the
manner as has been stated in the SOP/ Dossier / DMF.
• To get back the right data when needed for analysis.
• To save losses from Business due to data fraud.
• To establish the right work culture at work stations.
• Spent money is utilized the way it was Designed in the
approved processes.
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“Data Integrity” - Challenges
Data Integrity
Inadequate procedures in
SOPs.
Poor Training System / Employee
Engagement
Invalidated & uncontrolled
software systems
Improper equipment
procurement due to lack of
knowledge
Fraudulent intensions / following shortcuts/
Business Pressure
No system or poor system of Data checks &
Data Audit
Organization's action Organization's action
Organization's action Employee's action
Org
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“Data Integrity” – Assessment & CAPA
• New Assessment system
• Risk Based Approach
• Preventive Measures
• Intermittent Audits
• Data management system Development
• Evaluation of new equipment for data integrity system
• Audit , FAT & PAT based on Data Integrity system
• New SOPs, Documents describing Data Integrity system
• Modified Chang control approval process.
• Analysis on existing methods
• Market data assessment
• Review of failures
• Complaint Management system review
• CAPA system review
• Investigation system review
• Analysis System review
• Data Management System Audit
• Evaluation of Current Processes
• Training of Personnel
• Management focus
• Survey of data Fraud Linkages
• Organization’s Aim assessment
Current status Checks
Current status Checks
Risk Evaluation
Risk Evaluation
Designing CAPA Actions
Designing CAPA Actions
Continuous Improvement
Actions
Continuous Improvement
Actions
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“Data Integrity” – Management Supports M
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Boosting Of Employees Morale & Motivations
Boosting Of Employees Morale & Motivations
Audit by External / Internal Agency
Audit by External / Internal Agency
Focus on System Development &
Making a Part of MIS
Focus on System Development &
Making a Part of MIS
Necessary Investment
&
Administrative Actions
Necessary Investment
&
Administrative Actions
“Data Integrity” – Employees’ Contributions E
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Employees &
Data Integrity
System
Act the way of SOP
Be Ethical
&
Report Issues
Prevent Fraud by reporting
cases
Learn the Process
Be In System Be Open
Be Innovative Be In Policies
“Data Integrity” – Vendors management V
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Training for the Data importance &
Data Management at their Place
Making agreement incorporating data transparency & integrity
requirements.
Vendor Audits & rewarding good vendors by means of increased price or any other ethical means. Involving
good vendors in the organization’s celebration of events
“Data Integrity” – Customers Education C
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Take part in Customer’s satisfaction
survey
Listen to Customers Visit Customer’s Place and guide
them
Sharing Knowledge
&
Issues
Support
Customers in learning
Training by calling them in-
house
Support them with system
requirements
Design Actions for Your Organization
Obtain Regular feed back
“Data Integrity” – System Requirements C
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* Fraud Control
mechanism
* Mistake Proof
Systems
* Password protection
* Training & Evaluation
Data Acquisition systems on hardware
Data safe Software
(Tamper Proof)
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Thanks