Pharma Software team has developed, successfully implemented, supported installations and marketing stability & control software a cost effective stability management solution. Originally developed by support of pharmaceutical scientist for pharmaceutical scientists is withstanding the test of time, ever-evolving regulations, and advancements in new technologies.
Sample Management Software helps to manages stability plan and testing, enabling customers to define the test parameters for stability studies, as well as sampling time points, package types, and test methods. It also is used for control sample testing. Sample Management Software is 21 CFR Part 11 compliant, with a complete audit trail easy to retrieve desired output.
Challenges related to stability planing & testing
- To check variation in quality of drug over a period of time under influence of environmental factors like temperature, light and humidity to establish shelf life and recommended storage condition of drug.
- Managing number of batches
- Inability to evaluate stability data and derive suitable conclusion
- Beign numerous batches and products track
Features of On-Time Calibration Software
- Maintain Stability Protocol Reference Number, Stability Entry register, Withdrawal register etc.
- Product master and other parameters can be configures
- Email/SMS alerts and reminders and esclations
- Intuitive reports
- Can integrate with hardware and monitor stability chamber temprature and other parameters
- SMS alert on temperature drops or rise then default set temperature
- 21 CFR compliant
- On-Premise or Cloud solution