Bangalore based MetricStream, a market leader in the enterprise-wide Governance, Risk and Compliance (GRC) and Quality Management solutions, has announced that Kendle International Inc. (NASDAQ: KNDL), a leading global clinical research organization (CRO), has selected the MetricStream platform and solution for compliance and quality management, automating and streamlining its auditing and corrective action/ preventive action (CAPA) processes.
As one of the world’s largest global providers of Phase I-IV clinical development services, Kendle is focused on innovative solutions for its clients that reduce cycle times and accelerate the delivery of life-enhancing medicines to market. Tools such as the MetricStream platform enhance Kendle’s worldwide, class-leading operational practices, which are designed and executed to ensure compliance with both worldwide regulatory and client requirements.
“We are pleased to have Kendle as a customer and we look forward to this implementation,” said Shankar Bhaskaran, Senior Director & Head of International Business Operations at MetricStream. “Kendle presents an exciting opportunity for MetricStream. We are thrilled that our platform will play a critical role in further enhancing Kendle’s quality management processes, while at the same time, driving down the cost of compliance for Kendle and its clients.”
MetricStream’s solutions allow organizations such as Kendle to automate the tracking and management of compliance and quality events to ensure that operational activities are continuously measured, monitored and improved upon. As part of Kendle’s commitment to continuous improvement, MetricStream will deploy its advanced, risk-based audit management module to automate and streamline all aspects and functions of Kendle’s Clinical Quality Assurance audit program, from the management of periodic and ad-hoc audit schedules through the tracking of audit observations, findings, recommendations and the resulting audit responses.
The MetricStream solution will assist Kendle’s Clinical Quality Assurance auditors in planning and executing audits even more efficiently by providing a powerful, integrated tracking system and workflow engine, automating all steps in the audit lifecycle, including audit scheduling, audit preparation, audit execution, audit report approval, audit report issuance, audit response and any associated corrective action tracking.
In tandem with the MetricStream audit management module, MetricStream’s CAPA management module will be used to manage the implementation of corrective action/preventive action plans, providing seamless traceability for all related issues and incidents. MetricStream CAPA software will enable Kendle to implement a robust architecture for logging and managing quality issues originating from any source, while its automated workflow engine routes records through all investigation steps, including root cause analysis, CAPA planning, CAPA verification and effectiveness steps.
By providing an enterprise-wide system that can be accessed by all 3,600 Kendle associates across the globe, MetricStream’s integrated, web-based solution further enhances Kendle’s best-in-class service offerings for the biopharmaceutical industry.
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“Quality-of-service and a commitment to continuous improvement continue to distinguish Kendle in the marketplace. Critical initiatives, such as the MetricStream implementation, enhance Kendle’s ability to anticipate and respond to the constantly changing environment in which we operate. Enhancing Kendle’s already robust quality management system with the MetricStream platform will continue to improve cycle times for our clients, as well as reducing regulatory liabilities, risks, and costs for Kendle and our clients,” said Christopher Bergen, Executive Vice President & Chief Administrative Officer at Kendle.
MetricStream, with its India headquarters at Bangalore, is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Solutions for global corporations.
MetricStream solutions are used by leading corporations such as Pfizer, Philips, NASDAQ, UBS, SanDisk, BP, Subway, Fairchild Semiconductor, Hitachi and TaylorMade-Adidas Golf in diverse industries such as Pharmaceuticals, Medical Devices, Automotive, Food, High Tech Manufacturing, Energy and Financial Services to manage their quality processes, regulatory and industry-mandated compliance and corporate governance initiatives, as well as by over a million compliance professionals worldwide via the www.ComplianceOnline.com portal.
For further information on MetricStream, please visit www.metricstream.com.