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Agile Software Development and Validation in a Regulated Environment

Agile Software Development and Validation in a Regulated Environment

Agile development methods are growing in popularity with a recent survey reporting that more than 80% of organizations now following an agile approach.

However, in regulated environments, computer system validation requires documented processes and detailed requirements that are traceable and tested thoroughly. How can agile work in such environments given the underlying assumptions behind the manifesto of the methodology? What can we learn from agile methodologies to help streamline traditional approaches?
Xybion Corporation © 2017

About Xybion Corporation

Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries.  Our unique solutions focus on regulatory compliance, GRC, quality management, GLP, integrated preclinical lab management, early-stage drug discovery, content migration and systems validation. Xybion specializes in helping companies improve their overall compliance processes and provides a complete view into organizational risk across global organizational models.

 

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"This white paper provides insights on how an agile approach can help you meet the user needs and can make sense in GxP environments."