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Computer System Validation

At HG, we specialize in ensuring the reliability and compliance of your critical computer systems in the pharmaceutical and life sciences industries. Our team of CSV experts is ready to collaborate with you, whether it's for new digital initiatives or addressing the complexities of existing systems.

Offerings Include:

  • System Assessment and Risk Analysis

  • Validation Planning and Strategy

  • User Requirements Specification (URS)

  • Functional Requirements Specification (FRS)

  • Traceability Matrix Development

  • Test Protocol Preparation and Execution

  • Change Control and Documentation

  • Validation Reporting and Compliance



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 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.


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