GxP Labs

Empowering GxP Labs: Expert Qualification and Compliance Solutions

Are you struggling to optimize your GxP lab’s data management and ensure compliance with industry standards? Sagax, a leading IT consulting company, specializes in providing top-tier services to the Life Sciences industry.

Expert GxP lab qualification for QC or R&D. Ensure compliance with guidance, system requirements, and business goals. Let’s tackle your challenges together.

Our Approach

Setting up a compliant, reliable, and secure lab environment is essential for GxP-regulated industries. Our GxP Lab services help you build, configure, and qualify your laboratory networks and instruments, ensuring they meet all regulatory standards for quality, safety, and data integrity.

Quality Culture

Our guiding principle places quality at the forefront, not an afterthought. We empower clients to adopt this perspective, elevating performance across all operational levels.

Compliance

Our quality management system development and implementation services are designed to help our clients comply with rigorous regulatory requirements, including FDA, EMA, and other relevant guidelines.

Efficiency

We work to improve our clients’ operational efficiency by optimizing their quality systems, thereby reducing waste and minimizing errors.

Flexibility

Flexible solutions for unique businesses. We understand your specific needs and develop strategies tailored to fit your culture and goals. Quality matters, and we deliver accordingly.

GxP Labs

Setting up a compliant, reliable, and secure lab environment is essential for GxP-regulated industries. Our GxP Lab services help you build, configure, and qualify your laboratory networks and instruments, ensuring they meet all regulatory standards for quality, safety, and data integrity.

Network Buildout

Network Buildout

Comprehensive network design and buildout to support your lab’s IT infrastructure with a focus on scalability and security.

Network Segmentation

Network Segmentation

We ensure your lab’s network is properly segmented to protect sensitive data and maintain regulatory compliance.

Network Qualification

Network Qualification

Verifying that your lab’s IT network meets all regulatory and operational requirements for secure, reliable performance.

Instrument Setup

Instrument Setup, Configuration, and Qualification

Full setup, configuration, and qualification of lab instruments to ensure they are compliant, reliable, and ready for operational use.

Periodic Reviews

Periodic Reviews

Regular evaluations of your quality systems to ensure ongoing compliance and alignment with the latest regulatory requirements.

Vendor Oversight

Vendor Oversight

We provide oversight to ensure that your vendors meet regulatory standards and align with your business goals.

Our Benefits

Our Quality Management System development and implementation services offer the following benefits:

Compliance With Regulatory Requirements

Our services are designed to help our clients comply with FDA, EMA, and other relevant guidelines, reducing the risk of non-compliance and potential regulatory penalties.

Improved Operational Efficiency

By optimizing quality systems, reducing waste, and minimizing errors, we help our clients improve their operational efficiency and reduce costs.

Customized Solutions

We understand that every business is unique, and we offer customized solutions tailored to meet our client's specific needs and requirements.

Why Choose Sagax?

Industry Expertise

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

Tailored Solutions

We recognized 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.

CONTACT US & FAQ

We start by thoroughly reviewing the validation documents provided by the equipment supplier and identifying any gaps relative to regulatory requirements and the client's operational needs. Our team then conducts supplemental qualification activities to address those gaps, ensuring full compliance and optimal performance of your infrastructure. Learn more about our Lab Instrument Qualification services.
Infrastructure Qualification ensures your IT systems and environments (networks, servers, data centers) are installed correctly, operate as intended, and meet regulatory requirements for life sciences companies. It's fundamental to maintaining data integrity and regulatory compliance. Without proper qualification, your critical systems and data are at risk, which can lead to compliance violations, data integrity issues, and costly operational disruptions Contact us to find out more.