Blogs
Our latest content
Check out what's new in our company !
Your Dynamic Snippet will be displayed here... This message is displayed because you did not provide both a filter and a template to use.
Computer System Validation
Don’t fall behind in the digital transformation of the life sciences industry. AUXO brings deep expertise in regulatory requirements, business processes, and IT to ensure seamless Computer System Validation (CSV).
We provide tailored validation solutions and comprehensive services to help you achieve the perfect balance between compliance and operational efficiency. Stay ahead of evolving regulations and accelerate your path to market with confidence.
Our Computer System Validation Solutions
Ensuring Compliance, Precision, and Reliability in Every System
Gap and Risk Analysis
It ensures that computer systems operate consistently, reliably, and in compliance with regulatory requirements. Gap and risk analysis are essential components of CSV, helping organizations identify deficiencies, assess risks, and implement corrective actions to ensure system integrity and compliance.
IT Infrastructure Qualification
Ensures that the IT infrastructure supporting GxP (Good Practice) systems is properly qualified to meet regulatory requirements, perform as intended, and maintain data integrity. Below is a detailed explanation of IT infrastructure qualification, its purpose, key components, and the overall process.
Software and System Validations
Validation is a critical process in regulated industries like pharmaceuticals, biotechnology, medical devices, and healthcare. It ensures that software systems meet regulatory requirements, perform as intended, and produce reliable, accurate, and secure results.
Utilities and Facilities
We provide infrastructure and support systems necessary for the production, testing, and storage of products. Proper qualification and validation of utilities and facilities ensure they meet regulatory requirements, operate consistently, and maintain product quality and safety. Below is a detailed explanation of utilities and facilities, their importance, key components, and the qualification process.
Technical Support
Assistance provided to users for resolving technical issues related to hardware, software, or other IT systems. It ensures that systems operate smoothly, minimizes downtime, and helps users effectively utilize technology
Read More...
Why to choose AUXO?
AUXO brings years of expertise across diverse GxP environments. Our validation approach is designed to adapt to emerging technologies, including machine learning and artificial intelligence, ensuring compliance in today’s rapidly evolving digital landscape. We help you understand the processes where your computerised systems are applied, providing deep insights into system functionality through a transparent, white-box approach. By defining optimal software validation and lifecycle strategy, ensuring data integrity, consistency, and full regulatory compliance with standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. With a focus on efficiency and precision, we minimise risks, reduce costs, and accelerate timelines, delivering validation processes that are both seamless and future-ready. Partner with AUXO to transform your validation challenges into opportunities for innovation, compliance, and long-term success.
15+
Years of Experience
Team specialised in delivering expert computer system validation / assurance services
125+
Systems / Softwares /
Servers Validated
Global Network
With decades of global experience in computer system validation, we deliver industry-leading expertise to meet regulatory needs.