We deliver a custom approach to computer system validation (CSV), computer software assurance (CSA), and software quality assurance (SQA). We can deliver a new validation program or simply target those areas where you need additional help.
Our consultants have extensive pharmaceutical, biotech, medical device, and software industry experience. They provide leadership to companies seeking to meet FDA, EMA, MHRA, and other agency expectations.
We can validate for you. Whether you are short on time or expertise, our experienced software validation project managers and engineers are available to get your validation project finished on time.
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Ensure the success of your validation projects… before you begin. Our consultants can help you implement a proven validation methodology and prepare your staff to use the latest computer system validation (CSV) and computer software assurance (CSA) techniques.
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If you know that your approach to software validation could be more efficient or more compliant, our consultants can help you identify process improvements and incorporate risk-based practices into your methodology.
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Know that your equipment is operating properly and that it meets both user and product-requirement specifications. Qualification testing provides you with this assurance.
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