Effective System Risk Assessments for Efficient Assurance

At Sagax, we understand that striking the right balance between risk management and documentation is crucial for effective and efficient Computer System Assurance. Our System Risk Assessments are designed to prioritize product quality and patient safety while minimizing unnecessary documentation.

We achieve this by employing the following best practices:

Risk-Based Approach

Risk-based approach for validation and documentation. Allocate resources to systems with high impact on product quality and patient safety, ensuring efficient compliance.

Cross-Functional Collaboration

Expert team with IT, quality, regulatory, and pharmaceutical industry specialists. Cross-functional collaboration for comprehensive and tailored risk assessments meeting your organization’s needs.

GxP Relevance

Targeted risk assessment for GxP systems impacting product safety and quality. Prioritize efforts and streamline documentation to ensure critical systems receive necessary attention and compliance.

Identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA)

Collaborative identification of CPPs and CQAs for processes and products. Assess risks linked to computer system failure, guiding validation and documentation decisions for optimal performance.

Use of Risk Assessment Tools

We employ widely-recognized risk assessment tools such as Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), and Risk Ranking and Filtering, to systematically identify, evaluate, and prioritize potential risks.

Risk Mitigation Strategies

Tailored risk mitigation strategies address impacts on product quality and patient safety. Designed to minimize system failure likelihood, reducing excessive documentation requirements.

Periodic Review and Updates

Dynamic risk assessments adapt to technology, regulations, and best practices. Periodic reviews ensure ongoing relevance and effectiveness, maintaining compliance and safeguarding product quality and patient safety.

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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.