Adapting Agile in Regulated (Pharmaceutical) Environment

Author

Prachiben K. Shah, Harrisburg University of Science and Technology

Completion Date

10-2017

Document Type

Thesis

Degree Name

Master of Science (MS)

Program or Discipline Name

Project Management

First Advisor

Dr. Thomas Sheives

Abstract

Pharmaceutical software industries practice traditional approach for years, and when it comes to a change they are struggling to adapt new software methodologies such as agile; which is most commonly used by IT industries. The most significant factor required for successful agile adaptation is to make sure new practices should be aligned with the pharmaceutical regulations and the process should be validated and properly documented as per the guidelines. Apart from this, there are few challenges that Pharmaceutical companies are facing to adopt new changes. Those challenges mentioned in various research articles are highlighted in this research paper. This research paper also mentions the possibility to overcome those challenges while adapting the agile practices for regulated software developments projects. This research contains the proposal of actionable items to make transition easier by making changes to traditional approach. The adaption plan will be developed by using findings from Diagnostic Grifols successful adaptation plan. This research paper highlights the insights of agile approach and the way to customizing the agile activities to meet safety and regulatory needs. Besides, QA activities and its contribution will be explored to ease adaptation processes.

Recommended Citation

Shah, P. K. (2017). Adapting Agile in Regulated (Pharmaceutical) Environment. Retrieved from https://digitalcommons.harrisburgu.edu/pmgt_dandt/16