Validation Planning: Ensuring System Performance and Compliance

At Sagax Team, we are committed to providing comprehensive laboratory solutions that empower biotech companies to optimize their operations, maintain regulatory compliance, and drive innovation. Expert team provides tailored GxP lab and lab informatics services, supporting all aspects of laboratory processes, data management, and technology implementation for high-level client assistance.

Our Validation Planning Process

Collaborate to establish project goals, system identification, and specific testing requirements. Targeted validation efforts aligned with your organization’s needs and priorities.

Conduct Functional Risk Assessment

Our team conducts functional risk assessments for high and some medium-risk systems. We identify potential risks, focus on critical aspects, and maximize efficiency while safeguarding quality and patient safety.

Develop Validation Plan

A detailed validation plan with clear acceptance criteria ensures an organized, efficient, and well-documented process, outlining validation activities, methods, responsibilities, and timelines, providing a benchmark for success.

Select Testing Approach

We help you choose between scripted (formalized, predefined test scripts) or unscripted (exploratory) testing methods based on your system’s risk level. This ensures the most suitable testing approach, optimizing resources and reducing the risk of system failure.

Coordinate Resources & Schedules

Our team works closely with your organization to coordinate the resources, personnel, and schedules needed for the validation process. This collaborative approach helps ensure that validation activities are seamlessly integrated into your operations, minimizing disruption and maximizing efficiency.

Monitor and Review Progress

We maintain continuous monitoring and review during validation, promptly addressing any deviations or issues. This ongoing oversight ensures the integrity of the process and supports project objectives.

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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.