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
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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