Computerized systems engineering, quality, compliance

With the SiemensPolarion ALM™ solution : ensure requirements traceability

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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)
  • 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.