Agile Software Development in Regulated Environment

For years now, pharmaceutical companies struggle with the adoption of various iterative software development methodologies for computer system applications that support regulated activities and must be validated. Industry best practices for computer system validation are structured around the standard “Waterfall” software development life cycle (SDLC) approach, in which there’s a clear linear progression, and the deliverables of each phase are completed before the team moves to the next phase of the SDLC. Iterative SDLC methodologies are based on multiple iterations of requirements definitions, software development, testing, and user experience with the system that lead to a refined software product that meets the users’ needs.
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Commercial Compliance in the Cloud: Countering Concerns, Celebrating the Promise for Digital Asset Management

Fewer than 50% of pharmaceutical companies have adopted cloud computing technology, based on data from the International Data Corporation (IDC).
This doesn’t surprise me because when the subject of managing commercial compliance in the cloud is raised, questions are typically asked with great trepidation.
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Vendor Control with Partnerships, Not Checklists

More than ever before, pharmaceutical companies leverage the expertise of software, infrastructure, and service providers as an alternative to building equivalent capabilities in-house. Indeed, outsourcing and partnerships with external service organizations, cloud infrastructure providers, and software vendors have become strategic initiatives in most organizations’ plans.
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