Data Integrity Program Management

Minimising risk

Providing assurance

At Integrity, we understand how an effective Data Integrity program can deliver the required culture, governance, quality system and technologies needed to minimise data integrity risks. Therefore, making the Data Integrity Program a fundamental aspect of any regulated companies quality system.

It provides assurance that regulated data is effectively governed throughout the data lifecycle, ensuring it meets the ALCOA+ attributes.

Data Integrity programs can be large and expensive if not focussed on the key areas of risk.

Critical products and business processes must be identified to focus on the most critical GxP data and records.

Governance structures are established to direct and oversee the Data Integrity program and transition to “business as usual”.

Recognising there will be many functions across your organisation viewing data through a different lens, so it’s essential there is collaboration across the business to make sure the data governance strategies are aligned.

Our Data Integrity Program requires a multi-faceted approach that addresses culture, quality systems and technologies, to provide you with a balanced framework.

Our program will ensure your organisation has an open attitude to reporting and addressing potential data integrity risks and issues.

  • Organisation leadership must adopt appropriate behaviours across the organisation.
  • Education and training programs must highlight the relevance of data integrity within different organisational roles.
  • Process controls should be integrated into the Quality System to ensure that data integrity is part of the overall quality approach.
  • Process and technical controls should be matured to minimise data integrity risks and to improve the overall monitoring and detection of potential data integrity incidents.

We provide a team of experts to manage and support the delivery of your Data Integrity program.

Effective knowledge transfer from our team of experts to our client is essential to sustaining the data integrity controls environment long into the future.

The Data Integrity program should consider:

  • Identification of critical products and processes
  • Identification critical GxP records supporting the products and processes
  • Leverage historical learning (e.g. internal audits, regulatory inspections, Deviations, CAPAs, internal audits, Incident, and Issues)
  • Business process and data flow mapping
  • Business process and data flow risk assessment
  • Maturity assessments (culture, organisation, records design, processes, technologies / systems)
  • GEMBA walks to observe data integrity controls and risks
  • Stakeholder workshops
  • Digital strategies

Risk-based remediation plans are established to improve the maturity of the data integrity controls environment. Quick wins such as establishing data integrity policies, training, governance committees, data review procedures should be implemented to achieve a near term improvement in controls. Plans should focus on the key risk areas and should adopt an approach to improve maturity over time rather than delaying improvements until the perfect solution can be implemented.

Maturity assessment, GEMBA reviews, audits and workshops are used to evaluate the status of data integrity controls.

GEMBA reviews are an effective way of identifying data integrity control deficiencies quickly by observing live operations.

It is really important that at the end of the Data Integrity program our clients are able to sustain the controls established by the program.

And it is therefore essential that Data integrity training is delivered across the organisation to reinforce the risks from data integrity incidents.

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