August 16, 2013 | Palo Alto, California: Onyx Pharmaceuticals, Inc., a global biopharmaceutical company, has chosen MetricStream’s comprehensive quality management solution to manage a wide range of quality and compliance requirements, including quality audits, corrective action/preventive action (CAPA), product complaints, deviations, and change control.

The solution will enable quality processes to be managed and tracked more effectively and efficiently, while simultaneously rolling up quality data from across the enterprise to be viewed at the top in real time. Using this data, stakeholders will be able to proactively mitigate quality risks, ensure compliance with quality standards, analyze trends, and make more informed decisions.

Headquartered in South San Francisco, California, Onyx Pharmaceuticals is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. In 2012, Onyx was recognized among the top 20 of the MedAdNews 21st Annual Top 100 Biotechnology Companies List.

“Patient Safety is important at Onyx Pharmaceuticals, and we employ some of the most sophisticated and cutting-edge technologies to monitor the safety and efficacy of our products,” said Ron Marchesani, Onyx’s Vice President, Quality. “With MetricStream’s help, we look forward to raising the bar even higher by implementing next-generation technology that will provide real-time quality data at our fingertips and strengthen decision-making.”

Ed Gemo, Chief Information Officer at Onyx Pharmaceuticals, added, “We selected MetricStream for its integrated and flexible capability to transform our quality management processes. In the future, we could potentially leverage the platform to manage not only quality processes, but also our full range of governance, risk, and compliance initiatives.”

The MetricStream solution enables companies to adopt a risk-based approach to their quality management programs. It simplifies and strengthens the complete audit lifecycle - from planning, scheduling and conducting audits, to routing audit findings for review and analysis, initiating follow-up activities, and monitoring the entire process. Any products or processes that do not conform to the desired specifications will automatically be routed through a systematic process of investigation, evaluation, and corrective action.

Leveraging the MetricStream solution, companies can automatically capture quality issues from multiple sources, determine root causes, and facilitate corrective actions. In addition, quality managers will be able to track customer feedback from various channels, initiate investigations, and conduct trend analyses to spot and correct recurring problems.

The MetricStream solution also consolidates and streamlines the complete range of a company’s quality management processes in a single framework, strengthening compliance with both national regulations such as FDA 21 CFR Part 11 and international regulations such as EU Annex 11. The solution is compatible with mobile devices and will provide a window to the enterprise quality management processes anytime and anywhere.

“We are delighted to help Onyx Pharmaceuticals enhance their quality management program through our leading-edge solution,” said Gaurav Kapoor, Chief Operating Officer at MetricStream. “Reputed organizations across Life Sciences, Pharmaceuticals, Medical Devices, and Healthcare choose to partner with us because we continue to push the envelope of innovation, and develop holistic and flexible solutions which enable organizations to successfully meet their quality, risk, and compliance objectives.”

About MetricStream

MetricStream, the independent market leader in enterprise and cloud applications for Governance, Risk, Compliance (GRC) and Quality Management, makes GRC simple. MetricStream apps improve business performance by strengthening risk management, corporate governance, regulatory compliance, vendor governance, and quality management for hundreds of thousands of users in dozens of industries, including Financial Services, Healthcare, Life Sciences, Energy and Utilities, Food, Retail, CPG, Government, Hi-Tech and Manufacturing. MetricStream is headquartered in Palo Alto, California, with an operations and R&D center in Bangalore, India, and sales and operations support in 12 other cities globally. (www.metricstream.com).

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