Computer System Assurance/Validation (CSA/CSV)
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 Approach
In today’s life sciences landscape, system assurance and validation are critical for
compliance and operational integrity. Our CSA/CSV services help you qualify and validate
your systems, infrastructure, and equipment to ensure they meet industry regulations and
perform as required for your business.
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.
Computer System Assurance:
A risk-based approach to validating computer systems, focusing on critical areas that impact patient safety and product quality.
Infrastructure Qualification
Infrastructure Qualification
Comprehensive qualification of IT infrastructure, ensuring it’s audit-ready and fully compliant with GxP requirements.Lab Instrument
Lab Instrument Qualification
We qualify lab instruments to ensure they produce accurate, reliable data and meet compliance standards.Facilities, Utilities, and Equipment
Facilities, Utilities, and Equipment Qualification
Thorough qualification of physical spaces, utilities, and equipment to ensure regulatory compliance and operational efficiency.CQV
Commissioning Qualification & Validation (CQV)
Ensuring that all systems and equipment are designed, installed, and operate according to predefined specifications.SaaS Continuous Compliance
SaaS Continuous Compliance
Ongoing validation and monitoring of SaaS systems to ensure they meet compliance requirements without interruption.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
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.
