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MHRA GDP SymposiumNovotel London West, London

8 & 10 December 2015

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Expectations of a GDP Inspection – Data IntegrityPresented by: Terry Madigan, GDP Inspector

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Aim

To answer:

• What is data integrity?

• Why is data integrity important?

• What does data integrity look like?

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What is data integrity?

The extent to which all data are complete, consistent and

accurate throughout the data lifecycle

- from initial data generation and recording, through

processing (including transformation or migration),

use, retention, archiving and retrieval (and

destruction).

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What is data integrity (DI)?

Simply put, data integrity is

Good documentation practice for records (hard

copy and electronic).

Data governance is

maintaining data integrity throughout the lifecycle.

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Why is data integrity important?

It is hard to make a good decision based

on data you cannot trust

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What are we looking for?

(1) Organisational culture, risk awareness and leadership

(2) Encouraging the right behaviours at all levels in the

organisation

(3) Designing systems to comply with DI principles

(4) Data review and system monitoring.

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What are we looking for?

(1) Organisational culture, risk awareness and leadership

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Organisational culture, risk awareness

and leadership

Organisational culture

The skeleton in the

cupboard – attempt to

hide stock from inspector

Hidden stock records?

Hidden complaints?

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Organisational culture, risk awareness

and leadership

Risk awareness

Multiple products stored in

same location

Stock with different status not

segregated (UK sale, export,

customer returns)

Reflected in poor record

management

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Organisational culture, risk awareness

and leadership

Leadership

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Organisational culture, risk awareness

and leadershipPositive Culture

• Quality is the understood and owned by everyone

• The wellbeing of the patient / consumer is paramount

• Risk is managed in a controlled manner

• Leadership drives good behaviour and practices

Negative culture

• “Quality” is seen as no more than a cost

• Patient / consumer wellbeing is not considered

• Risks are not appreciated or managed

• Poor leadership drives mistrust and lack of improvement

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What are we looking for?

(1) Organisational culture, risk awareness and leadership

(2) Encouraging the right behaviours at all levels in the

organisation

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Encouraging the right behaviours at all

levels in the organisation

Can staff give their supervisor ‘bad news’ without fear?

– I made a mistake…

– Internal reporting is encouraged

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Encouraging the right behaviours at all

levels in the organisation

Clear understanding of importance of data integrity at all

levels

• How do staff react to DI system weaknesses?

– Scraps of paper, unofficial note books

– Ignoring system alarms

– Sharing passwords

– Leaving computers logged on.

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What are we looking for?

(1) Organisational culture, risk awareness and leadership

(2) Encouraging the right behaviours at all levels in the

organisation

(3) Designing systems to comply with DI principles

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Designing systems to comply with DI

principles - paper

Attributable

Legible / Permanent

Contemporaneous

Original

Accurate

Aliases;

Process limitations

System design:

documents in right

place at right time

Verified ‘true

copy’ scans

Reflective of the

observation;

Data checking

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Designing systems to comply with DI

principles - paper

Poor paper system

design applied to inter-

branch delivery sheets

Attributable?

Legible/Permanent?

Contemporaneous?

Original?

Accurate?

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Designing systems to comply with DI

principles - electronic

Attributable

Legible / Permanent

Contemporaneous

Original

Accurate

Audit trails;

Metadata

System clock

synchronisation

Metadata which

permits

reconstruction

Data capture;

Manual data

entry

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Designing systems to comply with DI

principles - electronic

Poor electronic system

design leading to DI

problems

A single stock control unit

was allocated to reference

both sweetened and

sugar-free formulations

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Designing systems to comply with DI

principles - electronic

Is there evidence of non-

contemporaneous recording?

• Human/Machine interface

• Having to ‘remember’ values

and then record somewhere

else

Data conversion and

manipulation.

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What are we looking for?

(1) Organisational culture, risk awareness and leadership

(2) Encouraging the right behaviours at all levels in the

organisation

(3) Designing systems to comply with DI principles

(4) Data review and system monitoring

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Data review and system monitoring

Airway bill – evidence of

history of product movement

No review process to identify

missing data

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Data review and system monitoring

Does the data make

sense

– is it believable?

Certificate of authority

to wholesale medicines

in Kenya.

• Supplied direct from

the customer

• Not notarised or

authenticated

• Expired

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Data review and system monitoring

Does the data make

sense?

• Form design drives

incorrect behaviour.

• Data not reviewed to

assess if it makes

sense.

• Data is not

continuous.

• Daily temperature

range is not recorded.

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Data review and system monitoring

Data review – Paper and electronic

• Check source data and derived data

• Does it make sense?

• How critical is the data?

• Does it follow ALCOA principles?

Iterative data governance system review

• Quality Risk Management - type approach

• Self-inspection, review of deviations and

complaints…

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What does good data integrity look like?

Data you can trust

full knowledge of limitations in the data and data

generation process.

Data integrity measures are commensurate with criticality

of data and risk.

Weaknesses and errors are used as indicators for

improvement.

Generated in an open, honest, no-blame culture where

Quality principles are a normal way of being for everyone.

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Summary

• What is data integrity?

• What is data governance?

• Why is data integrity important?

• What does good data integrity look like?

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Thank you

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