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 Software and System Validation

 

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Ensuring Compliance, Precision, and Reliability in Every System

1

IT Systems and Network Validation

IT Systems and Network Validation is the process of ensuring that computerized systems, software, and networks used in regulated industries (such as pharmaceuticals, biotechnology, and healthcare) function correctly, securely, and in compliance with regulatory requirements.

2

Laboratory Equiment Software Validation

Laboratory Equipment Software Validation ensures that instrument software functions correctly, consistently, and complies with regulatory requirements, maintaining data integrity and accuracy in pharmaceuticals, biotech, and healthcare.

3

Compliance Services for New/ Legacy Systems 

Compliance services for new and legacy systems ensure that both newly implemented and existing (legacy) IT, laboratory, and manufacturing systems meet regulatory, security, and data integrity requirements in pharmaceutical, biotech, and healthcare industries.

4

Builiding Management & Environment Control System Validation

 Building Management System (BMS) & Environmental Monitoring System (EMS) Validation ensures that automated systems controlling facility conditions (temperature, humidity, airflow, pressure, etc.) function correctly, consistently, and comply with regulatory requirements in pharmaceutical, biotech, and healthcare industries.

Topic Walkthrough

What is Software Validation?

Software validation is the process of establishing documented evidence that software consistently performs as intended and meets predefined specifications and quality attributes. It ensures that the software is fit for its intended use, complies with regulatory requirements, and maintains data integrity throughout its lifecycle.

What is System Validation?


System validation is the process of establishing documented evidence that a computerized system (including hardware, software, and associated processes) consistently performs as intended and meets predefined specifications and quality attributes. It ensures that the entire system is fit for its intended use, complies with regulatory requirements, and maintains data integrity throughout its lifecycle.

How AUXO enhance tailored approach?

Automation: Streamlines validation tasks such as document generation, testing, and reporting.

Standardization: Provides templates and workflows to ensure consistency across validation projects.

Risk Management: Offers tools for risk assessment, tracking, and mitigation.

Efficiency: Reduces manual effort and accelerates the validation process.

Compliance: Ensures alignment with regulatory requirements and industry best practices. ​