Microsoft Team Foundation Server
Microsoft Visual Studio Team Foundation Server is the collaboration platform at the core of Microsoft’s application lifecycle management (ALM) solution. Team Foundation Server automates the software delivery process and gives you the tools you need to effectively manage software development projects throughout the IT lifecycle.
The Challenge
The Life Science industry is challenged by an ever increasing pressure to deliver cost-effective and efficient healthcare products and services that meet the strict requirements of global regulatory agencies such as the Food and Drug Administration (FDA).
Responding to this growing demand requires that organizations look closely at their existing Product Development Life Cycle methodologies and find ways to continuously increase productivity while maintaining the highest levels of quality and compliance.
One way many organizations have made significant inroads in this area is to implement automated Application Life Cycle Management (ALM) solutions.
Our Solution
QDS offers custom tailored solutions that help organizations transition to an electronic ALM environment while complying with FDA requirements for Validation and 21 CFR Part 11.
Our solution accelerator for Microsoft Team Foundation Server (TFS) enables development and IT professionals to focus on the Technology aspects of the implementation while realizing the benefits of having a fully validated production environment.
The Benefits
Our Solution Accelerator for Team Foundation Server includes the following elements:
- Verification of Regulatory Compliance Requirements against internal SOPs
- Synchronization of Business Processes and IT Compliance Requirements
- Mapping of Compliance Design Controls (21 CFR Part 820.30) to Technology Features, Functions, and Services
- Integration of existing Software Development Life Cycle Processes to Team Foundation Server Process Templates
- Validation of TFS Process Templates including configured/customized workflows
- Validation of Visual Studio Team System configuration (Source Control, Team Build, and Reporting Services)
- Validation of Windows SharePoint (WSS 3.0) Web Services, Portal, Content Management, and compliance configuration elements
- Validation of Technical Infrastructure components
- Comprehensive Validation Documentation including Validation Plans, Requirement Specifications, Technical Systems Design and Configuration, Traceability Analysis, Installation, Operational, and Performance Qualifications
- Project Asset and Code Migration Validation
- Development of supporting Business Process Instructions (BPI)
- Turnkey Project Management services