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Quality and Compliance Consulting

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Every solution you need for Computer System Validation, Auditing, CSV Methodology Design, Implementation, Enhancements, Project Quality Management Design, and Regulatory Compliance.

We understand the complex, ever-changing regulatory environment and markets with the challenges in healthcare, devices, and research industries to blend our expertise with business acumen to provide innovative and compliant solutions for various maturity levels of your organization.

Consulting best practices approach to reduce risk,
improve quality and optimize cost.

Validation Services

  • End-to-End Computer System Validation
  • Validation Testing Services
  • Equipment, Instrument, and Process Qualification
  • Automated Validation Tools Implementation

CSV Methodology Design, Implementation, and Enhancements

  • Adapt to any SDLC lifecycle
  • Assisting with the transition of traditional computer systems validation
  • Experts that bring robust experience with implementing proven computer systems validation lifecycle methodologies

Project Quality Management Design and Implementation

  • Quality solutions to design and implement compliance within your project management methodology
  • Introduce robust quality checks
  • Implement dashboards, lessons learned, and realization at the overall program level

Regulatory Compliance

  • Roadmap and strategize a phased appropriate Quality Management System (QMS) design
  • Develop quality manuals or policies
  • Support SOPs or WIs and forms
  • Support you with inspection and regulatory audit preparation

Automated Validation Tools Implementation

  • Enable real-time capturing of validation artifacts or deliverables
  • Control and maintain validation lifecycle phases from concept, project, operations, and retirement

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