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Audit Scope
Every Industry across the globe has to deal with the ever-increasing audit requirements as part of Quality, Safety, Risk assessment, health, environmental aspect. Audit is an independent systematic approach to determine standards, plans, effective implementation, results obtained are suitable to achieve the desired objectives. We as an Independent, Impartial, transparent, third party auditing agency, we asses, ensure and assure our clients across the industries and countries
Process Based Audits
Product & Service based Audit is a retrospective audit approach in which product & service will be examined and assess to ensure conformity as per the regulatory standards, sponsor obligations
Clinical trials are very important in product development to ensure the safety and efficacy. The safety data generated during clinical trials of new drug developments or bioequivalence generic drug development must be reported the concerned regulatory authorities as per the guidance.
We work with various stakeholders, Sponsors CROs, multiple sites and investigators and with data safety monitoring board committees. With an exceptional clinical experience we can offer
We conduct process based audits using check list of process techniques to add value beyond the verification of regulatory, internal written procedures and external requirements, which will help the organisation and sponsor in meeting the objectives of our critical process and assessing the effectiveness of the process
Processed based Audits will be conducted at on site, to focus how team members are prepare, produce, document, package, distribute those products gives us thorough understanding of the steps to streamline the effective processing
Process Audits are vital for high quality products or services, it is always better to conduct the process audits to ensure compliance with specific obligations, identify processing errors, determine process performance,
Product Service Based Audits
Product & Service based Audit is a retrospective audit approach in which product & service will be examined and assess to ensure conformity as per the regulatory standards, sponsor obligations
Product & Service based audits will be conducted after completion of the processing phase before reaching the product to the consumer at manufacturer end or at the broker or trader
We have an efficient team of Auditor those who can conduct these audits at the client site which will improve the quality, profits, brand image, customer satisfaction and loyalty
Our Audit approach is to identify the defects, non-conformities in the finished product or service, it will allow you to rework, repair, disposing in case of products, rework, develop another efficient strategy in case services
System Based Audits
System Based Audits are vital management tools for achieving the objectives set out in the policy of the organization. A system audit is a disciplined approach to evaluate and improve the effectiveness of a system. Audits are carried out in order to verify that the individual elements within the system are effective and suitable in achieving the stated objectives
The system audit also provides objective evidence concerning the need for the reduction, elimination and most importantly, prevention of non-conformities further to improving the performance of the organization
Our Auditing strategy focuses largely on Multiple Management System (Integrated Management System (IMS) and many organizations recognizing the importance of the Integration Management System. It allows the organization to minimize duplication and redundancy of effort, streamline or leverage the use of its limited resources, and reduce or eliminate overlapping responsibilities
Integrated Management System (IMS)
Risk Management System (RMS)
Environmental Management System (EMS)
Information Security Management System (ISMS)
Quality Management System (QMS)
Occupational Health and Safety Management System (OHSAS)
Purpose Based Audits
Audits are conducted with a purpose to ascertain the validity and reliability of the information and internal control of a system. It provides management with information on the efficiency with which the company controls the quality of its processes, products and system. Internal and External Audits follows a purpose to conduct the Audit either on site or onsite.
Our purpose based audits are conducted for various compelling reasons based on the purpose which includes but not limited to, non-conformance, unfavorable regulatory actions, due diligence- regulatory mock audits, selection and qualification audits, system and facility audits, total quality management, issues related data integrity
We have expert team to conduct investigational audits for non-assignable cause incidences, quality failures, process deviations and risk-based audits to evaluate the risks involved and mitigation strategy