CTG’s GxP Compliance Services support companies within the healthcare and life sciences industries to ensure their products are safe for use.

Whether you are a start-up company in need of professional expertise to set up and implement a business model for Quality, Validation, and Compliance, or a global life sciences company in need of resources to execute and manage validation and compliance projects, CTG’s Regulatory Compliance consultants are fully equipped to get the job done and satisfy your expectations.

Our services are based on lean, scalable and risk-based concepts, and designed using industry best practices.

That’s why CTG developed GxP Compliance Services

Our offerings enable clients to achieve and maintain their regulatory compliance objectives by providing a range of services in multidisciplinary environments like IT, Compliance, Risk, QA, and other.

  • Performance

    Enhancement of Process of Supplier Approval/Rejection

  • Risk

    Successful FDA and EU Inspections

  • Operations

    Compliance with GaMP 5 Expectations and Guidelines

  • Advantage/Strategy

    Significant Reduction of Validation Time Effort and Cost

  • Safety

    Cost Savings due to Process Improvements and Standardization

  • Security

    Minimization of Risks such as Data Loss or Corrupted Data

  • Script

    Delivery of Ready-to-Use, Correct, Secure and Compliant Spreadsheets

INTRODUCING CTG’S

GxP Compliance Services

Patient safety is paramount when performing clinical studies or using pharmaceutical products or medical devices. By applying Good Practices (GxP) quality guidelines and regulations, companies within the healthcare and life sciences industries can ensure their products are safe to use.

CTG’s approach to GxP compliance

To accommodate your organization to meet GxP compliance, we offer a variety of GxP Compliance Services. These services are based on lean, scalable, risk-based, and agile concepts, all following the latest standards in the market.

  • Process

    Agile Computer System Validation

    Ensures the validated state of your entire system

    • Risk based
    • Scalable
    • Lean
    • Successful FDA and EU inspections
    • Significant reduction of validation time, effort and cost
    • On-call assistance during inspections
  • Cloud Migration

    ERP/SAP Validation

    Leverages ERP/SAP knowledge and documentation to enhance validation

    • Excellent Baseline based on SAP specific supporting processes
    • Successful FDA and EU inspections
    • Significant reduction of validation time, effort and cost
    • On-call assistance during inspections
  • Analytics

    Outsourced Spreadsheet Validation

    Takes full ownership of the validation of your spreadsheets.

    • Successful FDA and EU inspections
    • Ready-to-use, correct, secure and compliant spreadsheets
    • No validation effort is required from your part
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    Agile Development & Computerized System Validation

    Ensures the validated state of agile developed applications.

    • Time and cost savings due to process improvements and standardization
    • Meet GaMP 5 expectations
  • Security

    IT Infrastructure Qualification

    Realizes a secure and easily maintainable IT infrastructure.

    • Increase of transparency and efficiency
    • Cost savings due to process improvements and standardization
    • Minimizes risks such as data loss, corrupted data to an acceptable level
  • Safety

    Compliance Assessment and Remediation

    Provides a detailed picture of compliance gaps and remediation measures.

    • An Assessment Report to enable monitoring of the remediation effort
    • Ready-to-go Roadmap for Remediation
  • Slides

    Vendor Audit

    Identifies the risks that can impact your business.

    • Enhancing process of supplier approval/rejection
    • Audit Report to enable you to monitor the remediation effort with your supplier
  • Technology Industry

    Equipment Qualification

    Qualifies a wide range of your laboratory equipment

    • Experienced Subject Matter Experts on all types of equipment
    • Deliver equipment that is qualified according to current best practices and regulatory requirements
    • Free of charge after care within a year
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    Training and Coaching

    Helps your organization get a better understanding of compliance topics.

    • Increase in effectiveness and efficiency
    • High ROI
    • Training that is tailored to your specific business needs

View our GxP overview collateral for more information about how CTG can help you in your validation and compliance projects.

View Collateral

Case Studies
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The CTG partner network is built to combine today’s leading technologies with CTG’s digital transformation IT solutions and services to accelerate our clients’ transformation initiatives.

Given the accelerated pace at which new technologies emerge and the specialized and evolving needs of our clients, it’s essential that we leverage industry partnerships to amplify the value we provide to clients.

Our strong partner network provides clients with even greater speed, adaptability, and confidence that their IT and digital transformation initiatives will be powered by the technologies, skills, methodologies, and industry experience necessary to achieve their desired business, technology, and operational outcomes.

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How CTG can help you achieve your desired business outcomes through digital transformation.

Send us a short message by completing the contact form and we’ll respond as soon as possible, or call us directly.

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