As a regulated company, you need to ensure your computer applications meet your needs for functionality, patient safety, product quality, and data integrity. Unneeded documentation, redundant testing, and perceived regulatory burden distract us from our primary goals to protect public health and encourage technological advancement in our manufacturing systems.

In this white paper, we compare Computer Systems Assurance (CSA) and Computer Systems Validation (CSV) and provide valuable information on the history, validity, purpose, and implementation strategies for CSA. 

Table of Contents

    • Different paths to the same destination
    • What is the difference between CSA and CSV?
    • 5 things you need to know about CSA
    • CSA/CSV comparison
    • Benefits of CSA
    • How do you move from CSV to CSA?
    • How do you think critically about risk?
    • Trusting your team
    • Adjusting to a new approach
    • Hiring consultants
CSA vs CSV white paper

Download the CSA vs CSV White Paper today!

As a global leader specializing in CSA consulting services, PSC Biotech® works to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines. Our goals are to provide tailored professional services, act as a seamless extension of life science companies, assist you in producing the highest quality products possible, and ensure processes are functional and in full compliance.

We look forward to hearing about your needs in CSA and whether we can be of service. Please get started by emailing us at info@biotech.com or using our contact form online.

See Also

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ACE

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