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Warning letters, 483s, Recalls, Import Alerts, Audit observations

Updated on August 8, 2025

Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability Mapping of Drug Products.

The Apps are supported by Qvents Quality Insights Posts which detail the GMP and Regulatory requirements. Often regulatory guidance’s and requirements are very generic with minimal practical implementation guidelines. Qvents Quality Insights and Templates provides useful templates for documentation and evaluation of complex GMP elements and QMS processes.

Check out the Qvents Apps Tools Here:

 

FDA 483 to Chinese API Manufacturer Sichuan Deebio cites Data Integrity issues (Qvents News).

  • For APIs, Excipients, Process Water, Drug Products
  • Provides structured user-friendly solutions. Guides you through the Risk Assessment Questionnaires
  • Fill in the Questionnaire responses, Get the Nitrosamine risk results and carryover potential for Nitrites, Amine residues
  • The tools assess the Nitrosamine formation risk, generate Recommended actions
  • The tools are aligned with current US FDA and EU guidelines, IPEC Questionnaire for Nitrosamine Risk Evaluation

Click Here for the Nitrosamine Risk Assessment Tools

  • Designed in line with USFDA’s 2011 guidance on Process Validation
  • Generate Control Charts with Signal identification, Shifts, Drifts, Outliers, CpK, Control Limits (LCL, UCL), Coefficients of Variation
  • Fill in your CPV Criteria – Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs) and defined limits. Enter Batch details. Define the number of batches to be considered for setting Control limits
  • Submit and generate the Control charts.
  • The Qvents Post Continuous Process Verification (CPV) and Evaluation Templates guides you through the
    • Selection of CPV Criteria
    • Interpretation of the CPV Criteria – CpK, %RSD, Detection of process variability through Signals, Shifts, Drifts in the Control charts and the CPV Parameters

Click Here for the Qvents CPV Tool

Supply Chain Traceability Mapping Tool

  • EUGMP, EudraLex, Annex 16 require complete Manufacturing and Distribution supply chain of medicinal products to be documented and available
    • APIs, Excipients, Packaging Materials, Key Components, Manufacturers,
    • Intermediaries involved – EU Importer, Warehouses, EU Testing Labs, QP Certifying the batches
  • Qvents Supply Chain Traceability Mapping Tool provides a useful tool for generating the Supply Chain Traceability Tree and Visual Map.
  • Fill in the details, generate the supply chain tree and traceability map. Move and adjust the nodes in the map to get the best visual representation of the supply chain map.

Click Here for the Qvents Supply Chain Traceability Mapping Tool

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