Reach compliance in the pharma sector by using a requirements software

Requirements Software for Medical and Pharmaceutical Sector

Our Benefits

  • Support to automated system validation activities, in accordance with GAMP 5 guide.
  • Manage the system validation process by defining requirements, specifications, test and risk and traceability between them.
  • Automated templates and documents for the validation project. This translates to a low validation cost and effective time management.
  • Support to bottom-up risk analysis (define attributes for each system function or user requirements in such a manner that the key factors for determining the risk can be identified) and top down risk analysis (obtain the risks identified to the attributes and mitigate them).
  • Manage intuitively the following matrices: URS – FS, FS-TEST OQ/PQ, URS-TEST OQ/PQ
  • Import and export requirements from Word and Excel by simply clicking a button.
  • Manage traceability and impact analysis.
  • Reuse requirements,validation procedures and requirements specification services in different projects by using reusable components functionality.