Manipal Acunova awarded with ISO Certification First contract research organisation to be coveted with this honour in the Country
July 22, 2006 (PRLEAP.COM) Education News. Manipal AcuNova is the first contract research organisation in the country to be awarded this recognition for adhering to all the mandates of business processes as mandated in the scope of registration.
The scope of registration covers the following areas of operations
• Clinical Operations
• Clinical Data Management
• Bio Availability / Bio Equivalence
• Central Reference Laboratory
• and support services
The certificate was formally handed over to Dr Ramdas Pai, Chairman, Manipal Group in the presence of Mr. D A Prasanna, Vice Chairman and Managing Director, Manipal Acunova ltd, by Mr. Venkitachalam, Managing Director, Underwriter Laboratories India Pvt Ltd.
Speaking on the achievement, Mr D A Prasanna, Vice Chairman and Managing Director, Manipal AcuNova said, “The achievement of the ISO 9001:2000 certification confirms to our customers that globally recognized and approved quality standards have been implemented in all our processes and operations facilitating better systems and cost effective management of the company. The ISO 9001:2000 certification also clearly establishes our long-term commitment to meeting and exceeding the needs and expectations of customers in a rapidly globalizing marketplace.”
About ISO 9001:2000 certification: ISO 9001:2000 is an international quality management standard and framework for business-to-business dealings, focusing on meeting customer quality and applicable regulatory requirements, enhancing customer satisfaction and continually improving business performance from the initial contracting stage through the delivery of service. The implemented management framework helps identify any system gaps, provides a strong foundation for system improvement and assists in organizational compliance with other accreditation programs
To obtain ISO 9001:2000 certification, auditors from Underwriter Laboratories visited Manipal AcuNova’s offices to obtain objective evidence about its quality management system. Detailed interviews with staff, as well as document reviews were undertaken to observe real time work processes. Over the next 3 years of Manipal Acunova’s certification, annual audits will be conducted to ensure adherence to the quality management system.
Notes to the editor:
About Manipal Acunova
Manipal AcuNova Ltd is a collaborative venture between the Manipal Education and Medical group and Acunova. Manipal AcuNova is a comprehensive, single source provider of clinical research and related services in the following areas:
• Bio Availability and Bio Equivalence Services
• Phase I clinical trials
• Clinical Trials from Phase II to Phase IV
• Clinical Data Management Services
• Central Reference Lab
Manipal AcuNova has access to Manipal’s 19 research sites, which is Asia’s largest academic medical centre treating 1.5 mn patients with 1500 physicians. Awarded as India’s No 1 emerging CRO in 2005 by Proximare Inc. (A New Jersey based strategic Consulting firm). . Manipal AcuNova has research facilities in Bangalore, Mangalore and Manipal as well as a wholly owned subsidiary in the US and UK. The quality standards conform to ISO, DCGI, ICMR,and ICH GCP guidelines.
For more information please visit: www.acunovalife.com
About Underwriters Laboratories:
Underwriters Laboratories Inc. (UL) is an independent, not-for-profit product-safety testing and certification organization. Since its inception in 1894, the company has held the undisputed reputation as a leader in product-safety testing and certification within the United States. Building on this household name in the United States, UL is becoming one of the most recognized, reputable conformity assessment providers in the world. Today, the company’s services extend to helping companies achieve global acceptance, whether for an electrical device, a programmable system, or an organization's quality process.