PRA International Chooses MetricStream for Regulatory Compliance and Quality Management
PRA is one of the world’s largest clinical research organizations, conducting clinical trials in more than 85 countries across six continents. Backed by over 30 years of experience and more than 2,700 clinical trials in the last five years, PRA is known for its high-quality service and commitment to excellence. PRA requires a sharp and consistent focus on quality and compliance management in order to continue that tradition as it operates in the intricate regulatory environment of global clinical research. MetricStream will help the company meet these demands by providing solutions to measure, monitor and improve quality, as well as manage regulatory obligations.
“We chose MetricStream because of its industry-proven expertise and integrated solutions that address our specific requirements,” said Jeannie Inge, Vice President of IT at PRA. “With MetricStream solutions, we believe that we can continue to set the benchmark for quality and performance standards and enhance our position as a leading global clinical research organization.”
“We are delighted to partner with PRA International, an organization that is truly committed to excellence. It validates our deep domain expertise and thorough understanding of the risk and compliance imperative in the life sciences industry,” says Carl McCauley, Vice President of Sales at MetricStream. “We look forward to working with PRA International and helping the company enhance quality management while confidently addressing compliance demands.”
The MetricStream Audit Management module will enable PRA to automate and streamline all aspects of the company’s audit program. The solution provides the flexibility to manage the complete audit lifecycle from planning and scheduling through implementation, reporting and review, and to audit recommendations and remediation. PRA will use advanced capabilities such as built-in issue tracking, remediation workflows, email-based notifications and alerts, and powerful reporting to implement industry best practices for efficient auditing to ensure ongoing compliance.
Integrated with the Audit Management module is MetricStream’s CAPA Management module. This application will help PRA manage audit findings, process deviations and quality issues from any point across the enterprise. The solution’s automated workflow engine routes such issues through all investigation steps, including root cause analysis, corrective and preventive action planning, action plan verification and effectiveness checks. Powerful analytics and reporting capabilities with graphical dashboards track each CAPA from initiation to closure, giving managers complete real-time visibility into the remediation and issue-tracking process.
MetricStream solutions for life sciences companies have been designed to address unique business challenges faced by organizations engaged in clinical research, pharmaceutical, biotechnology and medical devices fields in order to help them address complex regulatory requirements, industry mandates and client commitments, while improving enterprise collaboration. With MetricStream solutions, companies can manage these assurance functions efficiently and smoothly, using an integrated, centralized approach.
MetricStream 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, Subway, Fairchild Semiconductor, SunTrust Banks and Cummins 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. MetricStream is headquartered in Palo Alto, California and can be reached at www.metricstream.com.
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