Sections

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.

• ESSEM have Archive Facility where we can store all the data safe and securely (i.e., Electronic Record, Facility Records, Chemicals, Reagents, Solvents, Materials and Tissue).
• Controlled and Restricted Entry.

• Test Item Control Office is a department responsible for receipt, storage, and dispensing of the test item and reference substance. This department ensures safe receipt of the test item, provides a unique code for each item, maintains its mass balance and documents; CoA, MSDS, TIDS and holds the same in environmentally controlled storage till usage, expiry and disposal.
• TICO has well distinguished storage for varied range of test items (both solid and liquid) depending on their nature and characterization.
• TICO is responsible for dispensing of test item and reference substance to the study director in guidance to its stability in air and light. They are also responsible for guiding the user/scientists about the hazards and safety involved in handling a given test item. Also, responsible for maintaining test item and reference substance utilization record.
• Controlled and Restricted entry.

• DCO is a department in which controlled documents are created, reviewed, distributed, and disposed off in a secure and efficient way. It helps to keep a track of all the document used in organization. Controlled copies of all documents (forms, formats, SOP's and other documents) are maintained in the centralized server to just avoid the breaching.