Quality Process Management

QualityExpert™ includes a preconfigured set of business processes designed for the quality management needs of life sciences companies dealing with industry-specific quality challenges in R&D, Clinical, Regulatory, Pharmacovigilance, Manufacturing. It incorporates best practices into common quality processes.



  • Quality Event Management through different types of Quality Events (Deviations, Complaints, Non-Conformances, Out of specification, …)
  • Investigation and Root Cause Analysis processes
  • Extension Request processes
  • CAPA processes and Effectiveness checks
  • Creation of Audit Plans, Audits, Audit Activities
  • Creation and approval of documents such as Audit Agenda and Audit Report
  • Automatic creation of Quality Events from audit findings
  • Change Control process linked to every other relevant process
  • Supplier Qualification process
  • Dashboards providing actionable QMS insights

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