Sarjen Systems Pvt. Ltd. software

Pharmaceutical companies are required to submit a full Product Quality Review (PQR) or APQR in the U.S. and PQR in Europe to government health authorities annually, detailing key aspects of the manufacturing process for each drug they produce. APQR or PQR is a mandatory requirement that used to verify the consistency and appropriateness of an existing manufacturing process. It plays a critical role in identifying any trends in the process further leading to process or product improvements. It is an evaluation which is prepared according to the CGMP requirements of different regulatory authorities. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product the content.

Investigation is an effective tool for identification of root cause for the potential issues observed in an organization. It ensures creation and effective management of investigation for identification of root cause. A configurable workflow design in place with defined responsibilities at each stage for speedy and effective conclusion in a time bound manner is experienced in an Investigation software. Quality related deviations and incidents in regulatory environment demand and effective root cause investigation for effective CAPA management and avoid reoccurrence of deviation and complaints.