Optimizing Global Pharmacovigilance Operations Management and Risk-based Compliance Governance
PVSentinel is a collaborative platform for programs/vendor oversight, managing ePSMF / digital SDEA, periodic safety reconciliation, agency audits/inspections, and continuously monitoring quality, compliance and risks across all PV activities.
PRINCETON, N.J. (PRWEB) April 08, 2019
Establishing the capability to make risk-based informed decisions with well-orchestrated pharmacovigilance (PV) processes is a key requirement for sponsors and affiliates. To stay compliant with evolving global safety and pharmacovigilance regulations while working with multiple vendors, business partners, affiliates and service providers, sponsors are striving to develop risk-based operational intelligence with integrated and insightful digital PV process management.
Common challenges faced by cross-functional pharmacovigilance teams such as manual tracking of reconciliation activities, cumbersome review and approval of SDEAs, maintaining physical Pharmacovigilance System Master File, missing important process alerts, poor coordination with multiple stakeholders, last minute preparation for audits and inspections and the biggest risk of getting Form 483s for non-compliance can be mitigated with Techsol’s PVSentinel Solution.
PVSentinel was designed to coexist with other PV process systems including Drug Safety, QMS, LMS, PQC, ERP and CRM applications allowing disparate information processed in each of these systems to be centrally managed with standard API-based integrations.
"Using PVSentinel, sponsors can seamlessly plan, execute, report and oversee all their pharmacovigilance programs, business process outcomes, partner and vendor activities and get notified immediately on compliance risks," said Jay Canter, Vice President of North American Business Development and Strategy, Techsol Corporation.
Cross-functional activities such as safety reconciliation, vendor oversight, quality and risk management, process and vendor compliance monitoring can be orchestrated with configurable workflows. The centralized PV Sentinel Inbox will unify stakeholder communication exchange and eliminate the usage of multiple email systems.
The PVSentinel Business Intelligence Studio module allows stakeholders to develop powerful operational intelligence and monitor trends of key performance indicators (KPIs), Key Risk Indicators (KRIs), Key Quality Indicators (KQIs) and Key Compliance Indicators (KCIs) using interactive local and global dashboards.
Additionally, the solution has a flexible business rules engine which can be easily setup to send automatic alerts and notifications to user groups. Stakeholders can stay informed and avoid missing or delaying critical events which can lead to process deviations, compliance shortfall and quality deficiencies.
"Advanced features such as collaborative Digital SDEA Management allows online drafting, review and approval of agreements using electronic signatures. Sponsors can leverage the electronic Pharmacovigilance system master file (ePSMF) to draft and update various module contents. With our client network, we are further advancing PVSentinel's capabilities by infusing artificial intelligence for process automation,” said Saad Rahman, Director of Product Management at Techsol Corporation.
About Techsol Corporation
Techsol Corporation specializes in offering cloud-based information technology services and innovative software solutions to global pharmaceutical, life sciences and healthcare companies. Founded in 2010, we are a market leader in providing highly configurable process-oriented technology solutions for digitally transforming pharmaceutical business operations across medical affairs, clinical development, drug safety and medical information management. Our domain-specific business solutions are focused on establishing cross-platform integrations, business process automation, facilitating stakeholder collaboration, risk-based validation, and providing operational insights with advanced data analytics. As a trusted technology partner, we continuously engage with our clients to provide strategic consulting services for solutions implementation, systems validation and cross-platform integration.
CONTACT:
Jay M. Canter
Techsol Corporation
M: +1 (518) 893-2515
E: jay.canter (at) techsolcorp (dot) com
W: http://www.techsolcorp.com
