Straightforward Validation with the GMP Compliance Package Software
Hamilton simplifies the Arc sensor validation process
With the development of the GMP Compliance Package software, Hamilton now offers its ground-breaking and user-friendly validation software to the user. It offers more than the management of user profiles and test reports for calibration and validation; in fact it paves the way for complying with the GMP regulations for configuration, communication and validation of all Arc sensors as well, along with legally compliant administration.
The key strengths of the GMP Compliance Package software lies in the automatic generation of sensor reports and a significant simplification of the validation process for GMP products which goes hand in hand with it. In addition, different user profiles can be administered and clearly assigned in the test reports, which are stored in the database and printed for signing. The redevelopment of the user interface for the Arc View handheld also shows that user-friendliness is reflected in all process steps. It provides optimum and virtually intuitive support for the user in selecting the process data captured by the sensor. This is a major contribution to simplifying the validation process, because the user can find all relevant sensor information in the test report which is automatically stored in the GMP Compliance Package database.
Simplified process sequence thanks to the GMP Compliance Package database
The logical process sequence provides the ability to create user accounts and upload them to the Arc View handheld. If desired and depending on the process requirements, Arc sensors can be assigned to the users and configured accordingly. Thereafter the sensor is calibrated according to the defined standard and consistent measuring accuracy is assured. The next step is the validation- the connection to the process control system will be tested and the signal transmission verified. The following communication report paves the way to the final sensor performance, which is tested after the validation process ends. If the measurements coincide with the process specification, the test report will be stored in the database. With the GMP Compliance Package software, Hamilton fully meets requirements of the Good Manufacturing Practice guidelines in production, testing and quality control for biotechnological and pharmaceutical processes.