The PH21 pharmaceutical quality assurance system enables you to control and evaluate your tablet testers, disintegration testers and weighing machines centrally. Once it is stored in the central product database, you can use product-specific data for all tests on the connected devices.
The system supports the connection of up to 32 external pharmaceutical testing devices. Such devices include Kraemer Elektronik's well-known UTS tablet testing systems, tablet hardness testers and disintegration testers, as well as weighing machines for in-process control.
Functionality
The full version of the PH21 software includes features for production such as:
Scalability
The PH21 system may be used to operate a single tablet tester in a conventional laboratory environment, or the PH21 system can operate multiple devices in a real-time in-process control application.
Robustness & Reliability
The PH21 system is designed for quality and in-process control in the laboratory as well as for production lights-off operation. Automatic sampling, testing and generating of test protocols, including online quality control charts with SPC-functions (Statistical Process Control) makes it the state of the art software in this field. All significant events are logged and may be analysed at a later time. Features like the Auto-Archive function allow to save batch data fully automatically onto an SQL database server, where the data is backed up and saved. This guarantees the robustness and reliability of the whole system.
Security
Every button may be assigned an access restriction level. Every user group has its individual access restriction, a numerical value from zero (no access restriction/super user) to nine (maximum access restriction/low priority user). This access control scheme can be tailored to any customer's security requirements. – The system is being delivered pre-configured as a standard version, ready to use.
Compliance
Beginning with the system design, special care has been taken to ensure proper operation of the system. Each new version is only being released after passing the internal testing / verification and validation procedure.
The PH21 software fully complies with FDA regulation 21 CFR Part11 and the European Regulations for software applications in GMP-critical environments within the pharmaceutical industry.
External Reporting Tool
A separate reporting tool has been developed to provide fast access to batch data archives. This special software package is very useful during Audits, when asked to provide test data from certain batches from years back. Since the reporting tool accesses the batch archives directly, it is not necessary to first restore batches. Fast and direct access is guaranteed through this new tool.
