SRC Awarded ISO 9001 certification
SRC has been awarded the ISO 9001:2008 certification in recognition of its standardized best practices acorss 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 the registration includes Bio availability & Bio equivalence, Clinical Development, Scientific and Medical Writing, Pharmacetical development services. NQA, a leading certification agency, visited SRC offices in Bangalore and Salem to obtain objective evidences to confirm the effective implementation of the ISO 9001 quality management requirements. The adherence and effectivness of the implementation of the quality management system would be ensured through annual inspections by the certification agency.
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.
SRC Awarded ISO 27001 certification
SRC has been awarded ISO 27001:2005 certification for Information Security Management Systems (ISMS) covering Bio availability & Bio equivalence, Clinical Development, Scientific and Medical Writing, Pharmacetical development services as the scope of registration.
Being in the highly regulated space, where every data and information generated from the studies, requires to be protected from unauthorised usage, the company felt that the certification is imperative to provide more comfort and assurance to the sponsor on their data protection and confidentiality.
The inspection was conducted by NQA, a reputated certification agency visiting Bangalore and Salem locations to obtain the objective evidence to conform the effective implementation of the standards.
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
SRC receives DSIR recognition for R & D Centre
SRC announces the receipt of prestigious DSIR certification for the R & D centre. DSIR is a department under the Ministry of Science and Technology, Government of India. This recognition is granted to those units which excel in innovative Research & Development with a vision of Enabling Indian industry to reach state-of-the-art innovation excellence and competitiveness through research & technological interventions.
WHO Public Inspection Report TB174: S-10-007 & TB202: S-08-010
SRC, located in Salem and Bengaluru was inspected on the above-mentioned dates. The inspection included training of one inspector in the conduct of a GCP inspection. The clinical part of the study was conducted in Semler located in Salem, and the bio-analysis was done by the Semler bioanalytical facility located in Bengaluru.
Focus of the inspection
The inspection focused on the bio-equivalence study conducted for the product. The inspection covered all the sections of the WHO GCP and GLP texts, including the WHO guidance for organizations performing in vivo bioequivalence studies.
WHO Public Inspection Report Study No S-10-103
The purpose of the inspection was to inspect the bio-equivalence study performed at Semler Research Center Pvt. Ltd (hereafter referred to as "Semler"), to assess compliance with GCP, GMP and GLP (as appropriate) and to verify the related source data for the above mentioned study.
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