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Data Integrity Assessments

  • ​Conducting gap analysis to identify arias of non-compliance.

 

  • Reviewing current data management practices and systems.

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  • Providing detailed reports with actionable recommendations.

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Implementation of Data Governance Programs

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  • Developing comprehensive data integrity policies and procedures.

 

  • Establishing roles and responsibilities for data governance.

 

  • Implementing controls to ensure data accuracy and traceability.

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Training and Education

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  • Conducting training programs on data integrity principles and best practices.

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  • Providing guidance on handling data in compliance with ALCOA+ principles.

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  • Educating teams on identifying and mitigating data integrity risks.

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Remediation Support

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  • Assisting in the resolution of data integrity issues identified during audits or inspections.

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  • Developing corrective and preventive actions (CAPA) ti address deficiencies.

 

  • Supporting the implementation of long-term solutions to prevent recurrence.

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Regulatory Compliance Support

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  • Preparing for regulatory inspections with a focus on data integrity.

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  • Ensuring compliance with FDA, EMA, MHRA, WHO, and other regulatory guidelines.

 

  • Developing and reviewing SOP's and documentation related to data management.

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Deliverables

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  • Comprehensive data integrity assessment reports.

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  • Custom-tailored data governance frameworks and policies.

 

  • Training materials and certification for personnel.

 

  • CAPA plans and implementation support documentation.

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