Enabling FDA Regulatory Compliance and Quality of Operations through Computer System Validation


Learn more about Microexcel’s Computer System Validation solutions, and the way they enable statutory compliance in the HLS sector. Download this checklist to understand the compliance process, ensure that the software tools and technology environment comply with Food and Drug Administration (FDA) norms and meet the standards set down for the industry.

For companies in the Healthcare, Life Sciences, and Pharmaceuticals industries it is critical their products meet the regulatory standards for quality, effectiveness, and are defect-free without any adverse effects on patients using them. The regulations are set by the Food and Drug Administration (FDA) and require all companies in the Healthcare and Life Sciences (HLS) vertical to abide by it and be compliant with the mentioned standards.

The standards include operational processes, systems, software, and hardware assets, and cover the entirety of operations. Quality cannot be determined at the end point, but needs to cover the entire lifecycle of manufacturing, storage, and distribution. Failure of compliance requirements can lead to the cancellation of licenses and other legal penalties, making it a compulsory process for the HLS vertical.

Benefits of Computer System Validation


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

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

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

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

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

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.

The Role of Computer System Validation in the Health and Life Sciences

The FDA mandates compliance to Computer System Validation guidelines for all organizational entities in the HLS vertical, which include manufacturers, distributors, storage providers, companies that sell vaccines and biologicals, and medical devices. Computer System Validation follows a step-by-step process that is like SDLC or testing processes but is carried out in-depth. The regulatory requirements include the outlined steps, and the validation needs to be supplemented by necessary documentation and metrics.

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