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.

Functionality

The full version of the Ph21 software includes features for production such as:

• maintain a product library with unlimited number of product specifications
• perform tests of different shapes and sizes of tablets
• create reports of individual tests, group of tests, complete batches and multi-batch reports (annual reports)
• provide menu-guided adjustment and calibration procedures, including reports and calibration interval control.
• multi-tester applications for weight, thickness, diameter, hardness, disintegration, friability etc.
• features for online-testing directly at the tablet press
• online quality control charts
• automatic data export functions
• ODT online data transfer options for multi-tester applications, where product and test data may be managed from a central admin system and automatically distributed to all testing systems.

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.

IPC-Functionality

Ph21 provides an in-process-control (‘IPC’) mode, where a second set of tolerance limits can be applied. These tolerance limits are usually set a bit closer than the quality control limits.

This way the system can act before the product will be out of the ‘official’ QC limits. Additionally to the Ph21 audit trail an alarm trail is provided where the user has to confirm andd comment alarms/out-of-spec conditions.

All alarms can be configured to release predefined actions (e.g. light a yellow or red lamp, stop the tablet press etc.). A quality control chart may be shown which is automatically updated after every test.

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 delivered pre-configured as a standard version, ready to use.

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.

Report Layout Configuration & Examples