Digital Enablement, Quality, Risk and Compliance Services

Our comprehensive approach allows us to anticipate and meet industry needs

What We Do 

Digitization and Automation for eQMS: Transforming Quality Management Systems through cutting-edge digitization and automation.

IT Quality Management System Development: Crafting bespoke IT Quality Management Systems to meet regulatory requirements and organizational needs.

Digital Compliance Transformation: Guiding organizations through transformative compliance journeys to meet industry standards.

IT General Controls, Privacy, and Audits: Ensuring robust IT governance through comprehensive controls, privacy measures, and audits.

Enterprise Risk Management: Strategically identifying, assessing, and mitigating risks to optimize business performance.

Data Integrity, Governance, and Framework: Providing end-to-end solutions for ensuring data integrity, robust governance, and sustainable frameworks.

Information Security Assessment: Conducting comprehensive assessments to identify and fortify against cybersecurity threats.

HIPAA, GDPR Assessment and Compliance: Navigating complex healthcare and data protection regulations to ensure compliance.

Cybersecurity Compliance: Aligning organizations with the latest cybersecurity standards and regulations.

483/Warning Letter/Audit Finding Remediation and Management: Expertly addressing regulatory findings and audit issues with precision.

IT Vendor Audit Support: Assisting organizations in conducting thorough audits of their IT vendors for robust partnerships.

IT Integration: Facilitating seamless IT integration to maximize the benefits of technological investments.

Quality Management System (QMS)/eQMS/GxP Audits: Conducting audits to ensure compliance and continuous improvement in quality management.

Device Safety and Security Dashboard: Offering advanced dashboard development assistance for real-time monitoring and management of device safety and security.

We Focus On

Systems Selection/Implementation Planning: Streamlining the process of selecting and implementing IT systems for enhanced efficiency.

IT Quality Operating Model Assessment: Evaluating and optimizing IT quality operating models for sustained success.

Technology Risk Management Dashboard: Providing a comprehensive dashboard for managing technology-related risks.

M&A Due Diligence: Ensuring thorough due diligence in mergers and acquisitions to mitigate risks and optimize value.

Computer System Implementation and PMO: Guiding organizations through seamless computer system implementations with effective project management.

Helpdesk and IT System Setup Support: Providing assistance in setting up robust helpdesk systems and supporting IT infrastructure.

Interim Quality and IT Leadership: Offering interim leadership support to drive quality and IT initiatives during transitional periods.

  • Simplified Quality / Compliance Processes and Controls
  • Built-in Compliance Frameworks
  • Reduced Risk and Increased Compliance

  • Reduced Product Quality Issues
  • Speed and Agility

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