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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