Getting Global Development Teams Together Using Rational

Black Diamond Clears Regulatory Hurdles by Getting Four Geographically Separated Teams to Work Together

The Challenge

A Fortune 100 pharmaceutical company had four geographically-separated application development teams forced together by acquisition. Each team had its own institutionalized software development process with different documentation sets. Software documentation was subject to review by internal quality groups and the FDA. The company’s multiple processes lead to serious inefficiencies, especially for global projects. Software that was certified for use at one site was not accepted at the other sites. Therefore, software had to be re-certified for each site using the sites’ particular process and documentation.

The Solution

Black Diamond was engaged to create and deploy a standard, FDA-compliant system development process. The process was based on the Rational Unified Process. The customized process was supported by integration and automation with the Rational tool set where appropriate. Hundred of stakeholders were trained and learned to use the new process and Rational tools.

The scope of the solution included:

• assessing the existing processes at all four locations
• running workshops to integrate the requirements of all four groups
• using RequisitePro to manage requirements for the new standardized, RUP-based process
• writing customizations for the Rational Tools
• running pilots of the new process on live projects
• training and mentoring project teams
• writing and managing communications plans to pull the four organizations together
• estimating and scheduling the project
• augmenting the team with the necessary skill sets to customize RUP and the Rational tools

The Result

Black Diamond aligned executives from all four organizations in support of the project. We facilitated requirements-gathering sessions with all four development teams and established their agreement on the requirements for a standard process. FDA requirements were also integrated into the process. The Rational Unified Process was customized to create a single standard system development lifecycle that met all the requirements. The Rational toolset was customized with integrations to support the new process. The customized toolset was deployed at each location.