High-Quality CQV Services with ASTM E2500 Compliance

At Sagax Team, we are dedicated to providing the highest quality Commissioning, Qualification, and Validation (CQV) services to our clients in the biotech industry. As part of our commitment to excellence, we follow the ASTM E2500 standards in all aspects of our CQV work. Ensure compliant facilities, systems, and equipment with our risk-based approach. Leverage ASTM E2500 for efficient validation processes, ensuring safe products. Trust Sagax Team’s CQV solutions for quality and compliance.

Governance

Validation Program Development

Comprehensive plan for systems, equipment, and processes meeting performance criteria and regulatory guidelines. Define scope, acceptance criteria, and validation activities with necessary documentation.

Quality Risk Management

Our experts help identify, assess, and control potential risks in your processes, equipment, and facilities. By proactively mitigating risks, we ensure your operations maintain the highest quality standards and comply with relevant regulations.

Policies and Procedures

Develop, review, implement compliant policies and procedures. Ensure system and process performance consistency, while maintaining proper documentation adhering to industry standards and regulatory requirements.

System/Equipment Impact and Criticality Assessments

Thorough assessments identify equipment/system impact on quality and compliance. Evaluate criticality to prioritize validation and maintenance, optimizing resources for enhanced reliability and efficiency.

Data Integrity Planning and Assessments

Support in establishing data integrity plans, ensuring accuracy, consistency, and completeness. Safeguard data integrity throughout its lifecycle for regulatory compliance and informed decision-making.

Execution

Commissioning

Structured commissioning plan ensures systems and equipment meet design specifications. Create protocols, execute tests, and document results for seamless services.

Cleaning Validation

Develop and execute cleaning validation protocols to confirm effective removal of residues and contaminants. Ensuring products meet highest quality and safety standards.

Process Validation

Process validation ensures consistent product quality. Design, execute studies to demonstrate manufacturing processes meet predetermined attributes. Support throughout validation stages.

Temperature Mapping Services

Accurate temperature mapping for storage and processing areas. Identify hot and cold spots, ensuring products remain within required temperature range for quality and stability.

Packaging Qualification

Design, test, validate packaging systems to preserve product quality during distribution. Assess materials, seal integrity, and package performance under diverse conditions.

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. What are your services

    We offer Lab Informatics and Quality & Compliance as our two key services. We can work on end-to-end managed projects or/and provide staff augmentation support

    Q2. Do you have an in-house team of consultants

    Yes we have an in-house team of consultants to support these services

    Q3. What is your offer structure

    Our offer structure depends on your specific need which our team of consultants can evaluate.

    Q4. How do I connect with you

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

    Q5. Do you do product development as well

    No we do not develop any product. We offer consulting services.