Development and Validation of Electronic Data Recording System, Integratable with all Other Systems to Create Complete Electronic Documentation

摘要

ABSTRACT As per the current expectation USFDA, MHRA and other major Regulatory Authorities, especially with respect to the Data Integrity policies, the Sponsor has decided to implement e-BMR project by end of 2020. However considering the current state of our different Electronic Records, and the complexity of the e-BMR project, this project cannot be achieved directly. A multitude of different systems has to be converted to ‘Electronic Records’. A number of other Systems and Equipments, which has Electronic Records, works in isolation and don’t interact with others. The systems which are to be converted to ‘Electronic Records’ includes different logs, like ‘Area and Equipment Usage Logs’, ‘Calibration Logs’, ‘Weighing Balance Verification Logs’, ‘Temperature and Relative Humidity Logs’. All these logs are to be converted to electronic records, before the next stage i.e. Integrating all Equipments and Instruments to the Central Server. Only after these two major system, along with other standalone systems like Bar Code Enabled Dispensing and Intermediate Storage Records are Online, that the main project e-BMR can be implemented, as it will require data from all other systems. This project is aimed for the 'Development and Validation of Electronic Data Recording System, Integra table with all Other Systems to create Complete Electronic Documentation’. There are no computerized systems available in Market which can meets this requirement. So a new computerized systems was configured and validated, which will later be integrated with other systems so smooth flow of data between all systems. Keywords: Data Integrity, Electronic Records, e-BMR