Computer System Validation

Ensuring regulatory compliance in HLS
with Computer System Validation processes

Computer System Validation

Learn more about Microexcel’s Computer System Validation solutions, and the way they enable statutory compliance in the HLS sector.



Computer System Validation (CSV) is a compliance process to ensure that the software tools and technology environment in Healthcare and Life Sciences (HLS) industries comply with FDA norms and meet the standards set down for the industry.

CSV is essential to validate that software and applications are certified for safety and efficacy and meet the intended requirement with precision and accuracy.

The Food and Drug Administration (FDA) defines CSV as

“Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled” – General Principles of Software Validation: Final Guidance for Industry and FDA Staff

The validation is carried out in regulated companies to prove that their systems, software, and processes are working as per the intended functionality, and do not deviate from the prescribed norms. The compliance with FDA regulation and guidelines is crucial in the Healthcare and Life Sciences sector, owing to the criticality of their operations.



Benefits of Computer System Validation

Improved_Efficiency

Improved Efficiency

A defect free software environment improves the efficiency of your operations. It also ensures that your products are manufactured in compliance with regulatory norms. This leads to optimized operational processes that ensure efficacy and improve quality of the entire operational lifecycle.
Early_Defect_Analysis

Early Defect Analysis

The validation process identifies defects in functionality, accuracy, and usability at an early stage. This helps in defect resolution and improves the quality of your products. It also identifies risks that can affect your operations, which can be mitigated at an early stage.
Regulatory_Compliance

Regulatory Compliance

Computer System Validation ensures that your software environment performs in the intended way and is compliant with FDA regulations. It is a requisite for SAP GxP validation and ensures that the end-products are safe to use.
Less_Errors

Less Errors

Computer System Validation performs a rigorous check on your software and applications, to weed out any anomalies and enable corrections that will lead to fewer errors in the future. The aim is to have a defect-free technology stack that will ensure error-free operations.
System_Reliability

System Reliability

This validation stage ensures that your systems and operational processes are working as per the intended requirements and are free from errors in the entire lifecycle of procurement, production, storage, sales, and distribution.
Data_Integrity

Data Integrity

A complete Computer System validation ensures the accuracy of your data and associated processes and is a major requirement for SAP GxP compliance. This stage incudes a complete audit of your data storage models, integration processes, and operational systems which access data.

What Microexcel offers

Microexcel, An SAP Solution Partner, with a vast experience in providing custom solutions in the SAP environment, understands the criticality of operations in the Life Sciences and Pharmaceuticals sector. We have enabled numerous clients in the above vertical to improve their operations with bespoke solutions and have enabled them to seamlessly achieve compliance with regulatory norms, leading to efficient operations and increased productivity.

Microexcel offers comprehensive Computer System Validation services for your SAP environment. We help in identifying defects and resolving them to ensure that your operations are complaint with FDA norms. This would be an added advantage for your SAP GxP compliance requirements.

If you are looking for a right technology partner for your Computer System Validation requirements, Microexcel enables you to meet regulatory norms with solutions that attune to your custom needs. Contact us for more information on how we can add value to your business and give you the perfect advantage.

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