Quality Assurance is the backbone of the Quality Management System. We believe that focus on quality starts from laying a strong foundation of robust Standard Operating Procedures (SOPs) which comply with all the applicable regulations, guidelines and standards. At DiagnoSearch, quality is everybody’s responsibility with an emphasis on ‘Right the First Time’ approach.
The Quality Assurance (QA) Team at DiagnoSearch is independent of all functions.
QA is involved in maintaining efficient and compliant SOPs including the ones required for accreditation standards. It is instrumental in conducting training programs and workshops to enhance learning.
Internal Audits conducted by the QA Team at DiagnoSearch verify compliance with SOPs and documented project specific requirements to identify any noncompliance, assess root cause, implement Corrective And Preventive Actions (CAPA) and identify opportunities for quality improvement. The Internal Audits and Investigator Site Audits conducted by the QA Team contribute towards the identification of trends and unforeseen potential risks, which are integrated into the project specific Risk Management Plan, along with mitigation strategies.
As a part of DiagnoSearch’s approach to help clients achieve compliance with regulations and guidelines, we offer the following Quality Assurance Services:
Investigator Site Audits as means of identifying gaps in the processes, overseeing effective Corrective And Preventive Actions by analyzing root cause to achieve protocol compliance and data integrity
Conduct GCP training workshops for Investigator sites that are relevant to site operations with a focus on practical solutions to achieve compliance
Conduct audits of vendors/service providers to assess suitability of services, compliance and compatibility with DiagnoSearch/Sponsor requirements
Conduct visits to partner laboratories involved in specialized testing to assist the development of Standard Operating Procedures relevant to laboratory scope of work, standardization of assays with a focus on study endpoints, quality control and setting up tolerance limits for accepting results that would provide reliable data