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Data Governance & Data Integrity

The whole is greater than the sum of its parts.

HG supports organizations in the design and build of effective, risk-based Data Governance aimed at sustainable compliance and innovation. From pilot-level data integrity projects to full-scale, global Data Governance programs, HG brings experience and practical methodology to foster the right culture and integrate the right risk-based procedural requirements and technical controls within the Pharmaceutical Quality Management System to assure data integrity compliance.

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Offerings Include:

  • Data Culture/Quality Culture initiatives

  • Design and implementation support for Data Governance to include Corporate strategy, policies and procedures, Data Governance “System Review”/Management Review (metrics and monitoring)

  • Data Culture, Data Governance, and Data Integrity Training

  • Data Integrity Risk Management:

    • Data Integrity Risk Assessments/Data Process Mapping

  • Cultural Governance

  • Data Integrity Present State Analysis’, audits, and assessments

  • Data integrity investigations

UPCOMING EVENTS

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2024 PDA/FDA Joint Regulatory Conference

09 September – 11 September, 2024 | Washington, DC

2024 PDA Annual Meeting

25 March – 27 March, 2024 | Long Beach, CA

48th Annual International Good Manufacturing Practices Conference

Monday, March 4, 2024 – Thursday, March 7, 2024 | Athens, GA

  • My organization needs training. How do I get started?
    HG offers a number of subject trainings for your organization including but not limited to: Data Governance, GMP, Quality Culture, Quality Assurance, and Data Integrity. If you would like to learn more about coordinating training for your organization, simply email max@thehenricigroup.com to request a consultation and we will connect you with the Subject Matter Expert on our team who can supply you with a proposal and outline of training options.
  • What size companies do you work with?
    Great question. HG works with all types of pharma, biotech, and medical device companies – from startups to large scale Fortune 500 manufacturers.
  • What geographical areas do you service?
    While HG is based in the United States, we travel around the world to support our clients. We provide both onsite and remote services to support the needs of your organization.
  • Can you provide staffing solutions?
    From time to time, every organization can use some assistance and support. HG can help source appropriate and trained candidates for short-term and long-term resource support in order to help your organization bridge its staffing gaps.

FAQs

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