eSTAR - Electronic Stability Testing Analyses & Reporting

EAPHARMICS eSTAR stability software completely supports the stability studies of Investigational New Drug Applications (IND), New Drug Applications (NDA) for both New Molecular Entities (NMEs) and Non-NMEs., New Dosage Forms, Abbreviated New Drug Applications (ANDAs) and Post Marketed Annual Stability Products for the drug substances and drug products including Vaccines.

EAPHARMICS eSTAR stability software easily manages thousands of stability studies with extremely intuitive browser based user interface that allows the user to access multiple levels of details with the powerful security features of ORACLE database. 2D QR scannable  labels make it easy for more information and available throughout the application for getting the information.

EAPHARMICS eSTAR stability software is a fully validated software system. It combines the ease of use of an object oriented browser style user interface and industry standard document that meets the regulatory requirements reporting systems. Drug stability studies are managed with more efficiency using EAPHARMICS eSTAR stability software's combination of multilevel features that helps to reduce the CGMPs operational errors, deviations and maximizing the regulatory approvals.....

DOWNLOAD EAPHARMICS eSTAR BROCHURE

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	Presentation Slide		eDM

To meet the stability requirements set forth by FDA; EAPHARMICS has developed the eSTAR Stability System 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 both experienced and occasional user the same level of comfort. The system also maintains multilevel security that ensures 21 CFR part 11 compliance. Modules make it easier but error free complaince process for stability testing flow until the final summary report for USFDA.. Four Climate Zones: Climate zone I, II, III, IV   Climate Zone I Temperate Climate Zone II Mediterranean, Subtropical Climate Zone III Hot, Dry Climate Zone IV Hot, Humid   Climate Zone Calculated Data Derived Data Countries Temp.* oC MKT** oC Humidity % r.h Temp. oC Humidity % r.h Climate Zone I *Temperate* Japan, UK, Northern Europe, Canada, Russia, United States 20 20 42 21 45 Storage Condition acc. to ICH Q1A: 25oC/60% Climate Zone II *Mediterranean, Subtropical* Japan, United States, Southern Europe 21,6 22 52 25 60 Storage Condition acc. to ICH Q1F: 30oC/65% r.h Climate Zone III *Hot, Dry* Iran, Iraq, Sudan 26,4 27,9 35 30 35 Climate Zone IV *Hot, Humid* Brazil, Ghana, Indonesia, Nicaragua, Phillipines 26,7 27,4 76 30 70 Temp* = Temperature, MKT** = Mean Kinetic Temperature

FDA Complaint Label DESIGN, CUSTOMIZE LABELS INCLUDING BARCODES  Design and Print Labels Accurately  Drug FDA compliance labeling and      serialization  FDA pharmaceutical validation  Secure variable data labeling  Labeling repackaged drugs   Secure Accurate Reliable Stability Testing, Simplified

INTEGRATED BARCODE SCANNING APPROACH THROUGH OUT eSTAR