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Agile Methodology of Development and How to be Compliant

Agile Methodology of Development and How to be Compliant
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Author(s): Yerramalli Subramaniam (CliniOps Inc., USA), Avik Pal (CliniOps Inc., USA)and Arindam Dey (HCL America Inc., USA)
Copyright: 2016
Pages: 16
Source title: Software Innovations in Clinical Drug Development and Safety
Source Author(s)/Editor(s): Partha Chakraborty (Cognizant Technology Solutions, India)and Amit Nagal (GVK Bioscience, India)
DOI: 10.4018/978-1-4666-8726-4.ch013

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Abstract

Given that Agile software development is preferred methodology for products and services in life science industry, in this chapter we will describe how to adopt Agile software development process and still be compliant. We will focus on few Agile methodologies and provide details on what design controls we can adopt in order for the product and process to be compliant. We will also focus on some of the tools that can be used to help put such design and process control in place where we can have complete transparency and traceability.

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