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Solution to automate key business processes for FDA cGMP regulations and guidelines |
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Aurobindo Pharma will deploy MetricStream solution suite managing auditing, product and process related non-conformances, issue investigations and reporting, change control, complaints handling, controlled documents and for developing and executing corrective and preventive action (CAPA) plans. Automation of these key business processes on an integrated compliance platform will enable Aurobindo Pharma to improve operational efficiencies, lower the cost of regulatory compliance and create a transparent environment for proactively identifying, tracking and resolving quality issues. The system will be compliant with FDA 21 CFR Part 11 requirements for electronic records and information systems. |
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Aurobindo Pharma is among the top five pharmaceutical companies in India manufacturing generic pharmaceuticals and Active Pharmaceutical Ingredients for the global markets. The company has 11 manufacturing plants conforming to cGMP guidelines and ISO regulations and has received 35 product approvals from the US FDA. “Being a pharmaceutical company operating in global markets, many of our business processes are affected by regulatory requirements in countries we operate in, such as the US FDA, UK MHRA, Health Canada and WHO requirements. Therefore, we sought an enterprise software solution to streamline and automate our quality and compliance management processes,” said Dr. A. Rama Mohana Rao, Vice President at Aurobindo Pharma. “After a thorough evaluation of multiple vendors, we selected MetricStream. We were very impressed with the comprehensive capabilities of their solution and the deep domain knowledge about pharmaceutical manufacturing environments within their organization.” |
"We are pleased that Aurobindo Pharma has selected our solution to streamline their key compliance processes", said Shankar Bhaskaran, Head of Marketing & Business Development, MetricStream Asia Pacific. “Our success at Aurobindo Pharma demonstrates the value of our GRC and Quality Management solutions for companies in the APAC region looking to adhere to international standards and regulations.”
About Aurobindo Pharma
Aurobindo Pharma Limited ( www.aurobindo.com ), headquartered at Hyderabad , India , manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company has received approvals for most of the targeted API and formulation facilities from leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada , MCC South Africa. The company's robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics. The formulation portfolio is built on six technology platforms such as immediate release generics, SR/CR generics, Orally disintegrating/Mouth dissolving generics, Combination products, Sterile/Lyophilized generics and Liquids/Dry syrups. Aurobindo has filed over 100 DMFs and 79 ANDAs for the USA market alone in addition to filings in other countries. The pace of filings is matched by rapid product approvals from various markets. Till date Aurobindo received 40 ANDA approvals (both final and tentative) from US alone. Aurobindo operates in over 100 countries and markets over 180 APIs and 250 formulations.
About MetricStream
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, Tyco Healthcare, Philips, American Airlines, NASDAQ, Sandisk, BP, Entergy, 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 ComplianceOnline.com portal. MetricStream is headquartered in Redwood Shores, California and can be reached at www.metricstream.com.
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