Computerized systems engineering, quality, compliance

Project management support

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PHARMASYS project management includes the following steps:

  • Requirement analysis
  • Solutions and architectures definition
  • Writing of RFQ / RFP / URS and management of submissions
  • Audit and choice of solutions
  • Project management
  • Requirements traceability matrix
  • Audit of project quality, White Paper
  • Quality audit – best practices (GAMP, Cobit, ITIL, CMMI…)
  • GxP Regulatory audit
  • Quality project plan, setting of a repository
  • Design Spécifications
  • Tests procedures
  • Operations SOP’s and validated state maintenance procedures
  • Assistance for implementation and training