Streamlined Compliance with Innovative Technology

At Sagax, we recognize the ever-evolving landscape of the pharmaceutical industry and the crucial role that technology plays in maintaining compliance with regulatory requirements.

Our Computer System Assurance, Validation and Compliance services are designed to keep your pharmaceutical operations running smoothly while adhering to the latest industry standards and the new guidance on Computer System Assurance (CSA) by the FDA.

Leveraging our expertise in Quality by Design, we ensure that your systems not only meet compliance requirements but also enhance efficiency and reliability.

Our Services

Computer System Assurance & Validation

Our team of experts utilizes a risk-based approach to Computer System Assurance, streamlining the validation process to reduce time, effort, and costs. We align with the FDA’s new guidance on CSA, which prioritizes risk management and a lifecycle approach to ensure consistent and reliable system performance.

Our Services Include

Quality by Design

We incorporate Quality by Design principles into our Computer System Assurance and Validation services, ensuring that quality is built into your systems from the outset. By focusing on proactive measures and continuous improvement, we help you minimize risks and enhance overall system efficiency.

Our Services Include

  • Quality Risk Management 
  • Process Performance and Product Quality Monitoring
  • Continuous Improvement Initiatives
  • Design and Development Reviews 
  • Corrective and Preventive Action (CAPA) Management

Compliance Consulting & Training

We provide comprehensive compliance consulting and training services to help your organization stay up-to-date with the latest regulatory requirements and industry best practices. Our team of experts will work closely with you to develop customized training programs and provide guidance on navigating complex regulatory frameworks.

Our Services Include

  • Regulatory Compliance Gap Analysis
  • Standard Operating Procedure (SOP) Development and Review 
  • Customized Training Programs
  • Compliance Audits and Inspections

Why
Choose Sagax?

Industry Expertise

Our team of professionals has extensive experience in the pharmaceutical and IT industries, ensuring that we understand the unique challenges and requirements of your operations.

Tailored Solutions

We recognize that each client has specific needs, and we are committed to providing customized, end-to-end solutions that align with your organization’s objectives and compliance requirements.

Proven Track Record

Our successful track record with clients in the pharmaceutical industry is a testament to our ability to consistently deliver high-quality, compliant, and efficient IT solutions.

Strategic Partnerships

We collaborate with leading industry partners to stay abreast of the latest technological advancements and regulatory updates, ensuring that your systems remain compliant and up-to-date.

Commitment to Excellence

We are dedicated to providing the highest level of service and support to our clients, continually striving to exceed expectations and drive success in the pharmaceutical industry.

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Contact Us & FAQ

    Q1. How long have you been offering services in Q&C

    Since 2018.

    Q2. Do you have in-house consultants to set up Validation requirements

    Yes, we have in-house CSA specialists.

    Q3. Is your team well versed with regulatory compliance format

     Yes, we have completed many successful projects due to our process and updates driven approach.

    Q4. What is the average experience of your consultants

    10 Years.

    Q5. How do I connect with you

    You can write to us at info@sagaxteam.com OR fill in the form on the “contact us” page and our team will get back to you.