RQA Data Integrity & Risk- A Practical Approach To Managing Issues
Presentation given in the DIGIT committee for the 2018 RQA Manchester conference by Ian Ramsay. Practical and pragmatic approach to evaluating GxP data integrity issues
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21 October 2018
Data Integrity
Background
Regulators have developed excellent
guidance on the topic
Increasing focus on the quality culture
Increasing focus on the driving factors
behind fraud/falsification
Heavy emphasis on pressure applied to
individuals and people in the business
However…..determining whether an issue is
deliberate falsification or a simple error is
very difficult
Principal Determining factor is INTENT
Difficult to determine Intent
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Ian.Ramsay@Ramsaypharma.co.uk
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21 October 2018
Data Integrity
Background
Inability of regulators to
effectively evaluate intent makes
it hard to evaluate a data
integrity issue
Difficulty in determining intent
leads to an assumption that any
DI issue is deliberate and/or
falsification
Companies often left to prove
their innocence- very challenging
Resources being diverted to
manage low risk events because
they are not fully understood
Other critical areas often suffer
as a result
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Ian.Ramsay@Ramsaypharma.co.uk
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21 October 2018
What Do We
Need?
A mechanism or framework for more
effectively evaluating data integrity
issues
A mechanism or framework for
prioritising data integrity issues
according to risk
A process for determining Intent much
more effectively
Get regulator buy-in
Prioritise what's important
Don’t forget the rest of the business
Reintroduce proportionality to Data
Integrity
Help Determine Intent
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Ian.Ramsay@Ramsaypharma.co.uk
1111
21 October 2018
What Do We Need?
Good News!......we don’t have to reinvent
the wheel here
Criminal justice has been thinking about
this topic for hundreds (if not thousands) of
years
There is an established approach to
classifying intent and degrees of deliberate
action
Often referred to as “Mens Rea” in common
law jurisdictions
Establishes a widely accepted framework
for determining the level of intent in any
misdeed 11
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21 October 2018
Summary &
Conclusions
Establishing a PROPORTIAL approach to data
integrity findings is key
Regulators need Industry to take the lead
Influence your regulators
Establish detailed procedures for how to
handle and investigate issues before they
happen
Ensure you have detailed, pre-defined
questions and topics to explore
Summarize your overall controls on Data
Integrity (Governance)
Document everything and make your case
regarding the risk
Don’t neglect other parts of your operations
Don’t ignore other risks