Rama K Pidaparti
Wipro Technologies Limited, USA
Title: Compliance and Traceability (CAT) using Regulatory Intelligence (RI)
Biography
Biography: Rama K Pidaparti
Abstract
Given the increased scrutiny of the agencies and not forgetting the un-announced inspections in Europe, it I imperative to have a good handle on compliance as all compliance risks are business risks. Hence, Compliance and Traceabity for the life sciences industry is the need of the hour, which will create a baseline for what are all the regulations and standards that a business needs to be complying to globally and also manage the new and changing regulations in an ongoing basis. To create the base line the source should be a dependable source of the global regulations and standards (called Regulatory Intelligence). Example of one RI source is Tarius (Denmark based), which will provide what regulations and standards to be complied to globally. Using this source one can create a baseline and monitor for all the changing and new regulations (and standards). This will enable businesses to know and track what needs to be complied to and monitor it. One this is known businesses can also do what is needed to comply and provide traceability to what is done to provide compliance evidence. This entire set up can significantly enhance compliance which will result in having a great control on price of non-compliance.