Data Integrity is greatly important because data without integrity puts our patients at risk.

Data Integrity is a ‘hot topic’ because many of the standard controls implemented decades ago for paper records, have not yet been implemented for electronic records and computer systems.

FDA, EMA, MHRA, WHO, PIC/S, ISPE, PDA – All of these organizations have recently published data integrity standards and guidelines.

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How We Approach Data Integrity Compliance

  • Data Integrity Gap Assessments

    Data Integrity Gap Assessments

    If you haven’t thought about data integrity before now, the best place to start is with a Gap Assessment. This will let you know where current systems and practices are already ensuring data integrity and where there are gaps to address.

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  • Data Integrity Policies and Procedures

    Data Integrity Policies and Procedures

    One of the first steps in ensuring data integrity is the implementation of a Data Integrity Policy and the development of procedures to embed data integrity best-practices into daily activities.

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  • Data Governance Programs

    Data Governance Programs

    As your data integrity practices mature, a Governance Program will ensure ongoing compliance and provide a forum for continuous improvements.

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