8th August 2018

Expert Advice: Clarity Compliance Solutions – Data Integrity

Data Integrity – Weaving into the Fabric

The issue of Data Integrity (DI) has been with us for several years since the regulatory bodies started to raise concerns. Draft and final guidance’s have been issued and recently in March the MHRA issued its “GXP Data Integrity Guidance and Definitions”, formally extending the DI issue into GCP/GLP/GDP/GPvP areas.

The world of DI is becoming clearer, but there is still variety, inconsistency and effectiveness of how companies are implementing DI into their organisations.

Project/Programme Approach

The DI activity at several of the companies encountered could be described as “Uncontrolled, sporadic activity being delivered by untrained people using inconsistent and unapproved methodologies”. Exactly the opposite of regulator expectation.

Taking a Programme approach with clear Strategic objectives, supported by a well thought out Project plan is essential. The plan should cover activities for creating a robust Governance led approved framework of SOPs/Templates WI’s in which to operate the Assessment of existing systems and the associated Gap Analysis and Remediation activities.

It should also include components to build DI into the fabric of the organisation – from new projects to system retirements, ongoing audit activities and repeatable DI training.

The objective being to create a description statement of “a well-structured and controlled program being delivered by trained people using well thought through approved methodologies, supported by a company Data Governance Committee”

Behavioural and Organisational Culture

Becoming more and more important to the regulators is building an open quality focussed behavioural and organisational culture into which DI can operate.

The majority of companies encountered are looking at this but not in any real drive or focus.

However it is essential to build an environment which from an individual perspective removes the fear of failure (or indeed the failure of others – since it’s not the lab analysts fault the batch is out of specification), and from an organisational perspective that by raising quality issues or failures there will be no bonus or career impacting outcomes.

This is commonly called the fraud triangle – of which we need to address:

• Organisational Culture
  Remove the Pressure – Financial or emotional force pushing towards fraud
• Behavioural Culture
  Remove the Justification – Personal justification of dishonest action
• DI Assessments
  Remove the opportunity – Ability to execute the plan without being caught

Finally, if we ensure a robust DI framework, we are not just operating compliantly, we are delivering effective robust processes for efficient business operations and ensuring we are focus on the key phrase “It’s all about the patient!”

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