We would like to introduce to you Hitachi’s Manufacturing Execution Solution (MES) software exclusively designed for the Pharma Industry complying with GMP and 21 CFR Part 11(E-Records, E-Signature) guidelines. Some of the key points of this solution are as follows:

1. Ensures Data Integrity and compliance with cGMP
2. Ensures completeness of all data including microbiological/Analytical data, manufacturing records as per the laid down BMR
3. Enables maintaining complete and accurate data from all Lab testing with facility of connecting to LIMS or attaching pdf report to eBMR
4. Ensures that all written procedures for numerous quality function, production and process control are displayed on system step by step and recorded.
5. Ensures good record and report documentation practices, including document control
6. Ensures that written procedures for the receipt, identification, testing and handling of raw materials are also recorded as per BMR requirement.
7. Sufficient controls over computerized systems to prevent unauthorized access or changes to data and avoids failure to have adequate controls to prevent omission of data