Your Pathway to Excellence

• ​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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