Ensure requirements traceability

PHARMASYS provides and deploys SiemensPolarion ALM™ Life Sciences. A complete and customizable collaborative solution of Application Lifecycle Management  (ALM) which includes Requirements Management and Questions Analysis (QA). Polarion is a software solution edited by SIEMENS.

A web 2.0 & unified solution which meets the projects and regulatory challenges :

• Manage the requirements in collaborative and shared modes (between departments, AQ, computing, IT contractors or integrators)
• Manage dynamic traceability from business requirements to tests
• Respond to audits and inspections
• Pilot each project progress through dashboards
• Correctly manage the validated status and project changes
• Manage the regulatory dynamic bases
• Evolve toward test automation
• Comply to 21CFR part 11 requirements
• Simple and user friendly tool setting which does not require administrator skills.
• Reversibility, open and standard environment, full web architecture, ability to generate Word, Excel or PDF for all deliverables

PHARMASYS implementation includes :

• Installation and configuration
• Project model definition and customization
• Implementation of a pilot project
• User help and assistance
• Full validation with POLARION ALM (TM)

SiemensPolarion ALM™ Life Sciences top functionalities are :

• Requirements definition and management : capture, lifecycle dynamic traceability matrices, use of models
• Risk analysis management
• Tests management
• Collaborative with Office (Word, Excel) in import / export mode
• Change management and impact analysis
• Malfunction & defect management and follow up
• Builds and release management
• Compliance and regulatory bases management
• Methodological baselines management (GAMP5, CMMI, SPICE…),
• Management of workflows, tasks, projects and plannings
• Variability management
• Project route map : metrics (KPI, dashboards) and audits…

SiemensPolarion ALM™ Life Sciences is built on a full web architecture with a centralized database and a secured access management.