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.

Benefits

Unified Processes

Quality management processes harmonization, through all departments and subsidiaries

Minimize risk

Monitor and control quality processes to minimize the risks of non-compliance

Optimization

Facilitate continuous improvement activities

Digital control

Eliminate paper based and uncontrolled workflows

Standardized Processes
Insight

Improve quality reporting

Compliance

Increase inspection and audit readiness

Features

  • 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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