eSTAR - Electronic Stability Testing Analyses & Reporting
We are the developers of affordable innovative quality control data management software for stability and annual product review tracking. For the last fifteen years, we have provided our clients with tools for data management, evaluation, and report generation that emphasize our principle goal of meeting our client's regulatory responsibilities.
EAPHARMICS eSTAR stability software is a web based application integrated with oracle database to monitor all type of pharmaceutical ( including controlled drug substances and biological products ) stability programs. EAPHARMICS eSTAR is exceptionally suitable software for international regulatory guidelines like United States Food Drug Administration-USFDA, Therapeutic Products Programme-TPP, International Conference on Harmonisation-ICH, Therapeutic Goods Administration-TGA, National Institute of Health Sciences - NIHS and European Medicines Agency EMA of European Union EU guidelines. The software is designed for pre-clinical, R& D and Post market for Innovator/Generic pharmaceutical companies throughout the world.
To meet the stability requirements set forth by FDA; EAPHARMICS has developed the eSTAR software package that handles all the requirements of a full-scale stability program. Sample management, report generation, and statistical evaluations are made available through an intuitive user interface that allows the experienced and occasional user the same level of comfort. The system also maintains multilevel security that ensures 21 CFR part 11 compliance.
eSTAR Stability Software
Web based application allows controlled access from any site around the world.
RELATIONAL DATABASE SECURITY With the power of ORACLE
RICH INTERNET APPLICATIONS (RIA) User Interfaces with power of ADOBE
BAR CODE SCANNING INTERFACE through out application.
Unlimited number of products, tests and testing protocols (matrix).
Application in production environment from day one.
High availability, Security, Scalability, Performance, Manageability, Support for large volumes of data.
Benefits of eSTAR:
Cost benefits by saving time and money.
Easy customization of Application including interoperability and interaction with existing software.
Seamless Migration of existing Data.
Customer support is easily available. 24/7 Support through EAPHARMICS eTicket.