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PVSentinel Audits and Inspections

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Proactively Manage PVops Oversight and Stay Ready for Audits and Inspections

There are several laws and guidelines govern the pharmacovigilance audits and inspections defined by agencies across the world such as FDA, EMEA etc. The aim of these laws such as directive 2001/20/EC, GVP Modules III (PV Inspections) and Module IV (PV Audits) and 21 Code of Federal Regulations 312.32. These regulations allow manufacturers to be more transparent and to encourage patients to participate more actively in the process.

Preparation and conduct of PV audit/ inspections is a tremendous time consuming, costly process and pose high risk for the manufacturer. As part of audit preparation, today, PV team members, QPPV, safety officers at global sites along with outsourcing team members rely on a manual collection of information/ updates from various siloed data sources and team members located across the globe. The team further spend time on numerous meeting/ conference calls and share information via emails, shared folders etc. trying to collect the most recent, accurate information. In addition, response and CAPA tracking is managed manually and in siloed/ dis-integrated systems often not owned by the Pharmacovigilance departments.

PVSentinel Audits and Inspections

PVSentinel Audit & Inspection solution is designed to help manage Pharmacovigilance audit data, and processes in a single, comprehensive framework. Audit & Inspection enable you to implement industry best practices for efficient audit execution and ensure integration of the audit process with the risk and compliance management system.

Key Product Features

  • Digital processes: 100% digitalization of information needed to plan, prepare, conduct, manage, report, follow-up, close and archive audits of pharmacovigilance department
  • Provides the flexibility to support all types of audits, including internal audits, operational audits, IT audits, supplier audits, and quality audits.
  • End-to-end functionalities for managing the complete audit lifecycle – from audit planning and scheduling, to the development of standard audit plans and checklists, to field data collection,
  • Comprehensive functionality to manage recommendations by auditees and implementation of audit recommendations
  • Seamless Collaboration: Collaborate with global team members both internal and external seamlessly
  • Signal management: Based on the suggestions from agencies, PVSentinel facilitates tracking and managing of Signals that are marked as Ongoing Signals
  • Track all product label updates and changes in coordination with regulatory departments
  • Facilitates a closed-loop audit cycle for recording findings, developing recommendations, and implementing action plans
  • Version Controlled: Access and manage version of audit reports with archived older versions
  • Alerts & Notifications: Get alerted and notified on work assignment, expiry and changes
  • Insights & Analytics: Ready to use and extendable dash boards, performance indicators. Share reports in various formats PDF, ppt, through various channels

System Integrations for Process Automation and Audit Support

The PVSentinel Audit & Inspections module supports the listed source system integrations to enable 100% process automation and helps companies to stay audit-ready.

  • Enterprise Quality Management System
  • Drug Safety Database
  • Signal Management System
  • Label management/ Regulatory management system
  • Training Management System
  • Other organization wide operational data source systems

How Do We Deliver

PVSentinel Audit & Inspection is a component of our PVSentinel platform. It can be deployed on its own or in combination with all of the PVSentinel platform areas for 100% digitalization and proactive management of Pharmacovigilance audits and inspections.

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