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,