ESSEM Compliance Solution Private Limited
has independent QA unit with well qualified and competent assessors, functioning with internal Standard Operating Procedures based on the principles of OECD GLP. The studies carried out at ESSEM will be audited by QAU for ensuring the integrity, quality and GLP Principles.
The QAU inspectors execute following three different types of audits as per the OECD GLP Principles:
Facility based which includes internal audit and departmental audit like TICO, Archives, IT, DCO, Research facilities and utilities. It also consist the observation/inspection of instrument maintenance, calibration and its validation. QA also review the SOPs, defining and monitoring audit observations, periodical update to the management.
Study based includes inspection of initiation phase (review of draft and final study protocol), in-life phase and reporting phase (review of raw data, draft and final report).
Process based includes the critical phases of all studies.
Controlled and Restricted entry.
ESSEM professionals attend scientific / QA / GLP conferences to gain the recent updates in various fields of research and regulatory standards. We are also conducting internal training programs with external expertise, which help us to aim the next areas of growth for our organization.