|Semler Research Center (SRC) has been awarded the ISO 9001 and ISO 27001 certifications|
Semler Research Center (SRC), has been awarded the ISO 9001:2008 and ISO 27001: 2005 certification in recognition of its standardized best practices and effective IT infrastructure deployment for data security across the organisation. The move comes, as SRC looks to leverage on domestic and international expertise to embrace global standards of service provision in compliance with applicable regulatory requirements to further its business objectives and scientific goals, and provide superior quality to its sponsors.
The scope of the registration includes Bio availability & Bio equivalence, Clinical Development, Scientific & Medical Writing and Pharmaceutical development services. NQA, a leading certification agency, visited SRC offices to obtain objective evidences to confirm the effective implementation of the ISO 9001 and ISO 27001 standard requirements. The adherence and effectivness of the implementation of the ISO standard requirements would be ensured through annual inspections by the certification agency.
Speaking on the occasion, Dr Krathish Bopanna, President and Executive Director said “We have been undertaking extensive preparations for the certification since September 2010, and are very happy with the outcome of our efforts. The ISO 9001 certification is a guarantee of our excellence in service and will certainly reinforce our credentials as a leading CRO. This acheivement of certification confirms our committment to quality and meeting the requirements of customers resulting in customer satifaction without compromising the regulatory requirements”.
On ISO 27001 certification, he said “It is an important milestone for us and reiterates our efforts in the direction of data security, confidentiality and client data protection.We recognize and understand that the security of our sponsor’s data is of vital importance and this independent accreditation should help our customers and their confidence that we have adequate measures and internal procedures in place to protect their data and eliminate any potential security risks. Being a CRO, we are privy to sensitive information related to a particular drug or trial under research and development and hence the leakage of such critical information may pose a real danger to the sponsor. This certification shows our committment to sponsors information security, business continuity and physical security”.
About ISO 9001:2008 certification:ISO 9001:2008 is an international quality management standard and provides a broad framework for implementing a sound quality management system across the organization focusing on various key business processes in meeting customer quality and applicable regulatory requirements, enhancing customer satisfaction and continually improving business performance.
About ISO 27001:2005 certification: ISO/IEC 27001 specifies requirements for the establishment, implementation, monitoring and review, maintenance and improvement of a management system - an overall management and control framework - for managing an organization’s information security risks. ISO/IEC 27001:2005 is the updated version of the British Standard for Information Security Management Systems, BS 7799-2:2002. The standard covers all types of organizations. The standard provides an ISMS model for adequate and proportionate security controls to protect information assets and give confidence to interested parties.
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