Innovative GMP-Monitoring System Tarqvara for the Pharmaceutical Industry with Full Validation Package

The Tarqvara GMP Monitor is an electronic system for continuous real-time monitoring and automatic recording of environmental parameters in clean rooms in pharmaceutical production, warehouses and health-care facilities. The system comprises reliable validated software, hardware and calibrated sensors from leading manufacturers, such as Vaisala and Dwyer, and is fully GMP-compliant.

Alarm/warning signals are generated, if controlled parameters are outside preset values for longer than the preset delay time. Hygienic signal panels made of AISI304 stainless steel with a protected color LCD touch-screen that can display any information in the specific format desired by the client, can be installed in clean rooms of grades D/C/B and in corridors to inform staff, through alarms and warnings, of deviations in the controlled parameters.

The Tarqvara GMP Monitor provides fully GMP-compliant recording of parameters, deviations and system messages. System reports in graphic or tabular form can be printed out, saved in PDF format or exported into MS Excel-compatible format. The system is equipped with Audit Trail functionality and is supplied with a full validation package in accordance with GMP / GAMP5 / 21CFR Part11.

A unique combination of expertise in both the fields of Validation / GMP / GAMP and IT / Automation allows our company to develop products that have a number of advantages over competing systems.

Client-Tailored Solutions

Tarqvara GMP-monitoring systems are developed ‘from scratch’ according to customer specifications, which allows individual customer requirements regarding interface, functionality, format of reports, appearance / visual design and other parameters to be taken into account.

Representative Parameters Recording

In the majority of systems a single record comprises either a single measurement result or the average of several measurements. A single measurement does not provide information about the process state between the measurements, while the average does not indicate possible peak values within the period. The Tarqvara GMP Monitor reads parameters once a second, and using the 60 measurements collected each minute records the first value in the period as well as the average, minimum, maximum values and the exact time of the minimum and maximum values, thereby providing users with all representative GMP-critical information.

Hygienic design and integration into clean-room structures

All Tarqvara GMP Monitor components that are installed inside clean rooms, including sensor mounting elements, differential pressure ports and alarm panels, have a GMP-compliant design and are made of polished AISI304 stainless steel and other hygienic materials. The equipment and accessories are specially designed for easy, quick installation and integration into conventional clean-room structures and easy maintenance.

Compact Database

Standard database engines used in most monitoring systems, such as SQL Server, consume a lot of disk space and are unnecessarily complex for the simple flat data structure of GMP process parameters and messages. The Tarqvara GMP Monitor uses its own validated engines for compact and efficient data storage. The annual data volume generated by a 100-channel system with 4-fold data redundancy would only be approximately 3 Gigabytes. A database covering a period of 10 years could be saved on a single memory stick, and it would take 100 years to fill an average hard disk.

High Reliability and Audit Trail

Bulky external shells (e.g. WinCC, Desigo, InTouch etc.) used in many monitoring systems usually include a large number of unused components, deprive a developer of flexibility and make a seamless design impossible. This greatly increases the volume of executable program code, challenges hardware, increases the risk of failures and causes problems in validation. The Tarqvara GMP Monitor has been developed to be a compact, directly executable application, which only includes components that are really used in the system. Specific measures have been taken with regards to both software and hardware to guarantee data safety/integrity and prevent unauthorized data manipulation. A continuous Audit Trail records all user activity and critical system events, such as system time change.

High Operating Speed

Displaying long-term curves, generating reports and working with archive data which covers long periods takes a considerable amount of time in most monitoring systems, while in extreme cases systems stop responding or even crash. The Tarqvara GMP Monitor uses powerful, efficient hardware system resources for direct access to memory and the file system, which results in a drastic increase in efficiency and operating speed.

Comprehensive Computer Validation based on GAMP 5

Monitoring systems suppliers often only provide standard documents or “white papers” for the development / execution environment (e.g. software shells from Siemens, Wonderware etc.) as validation documentation, while the actual developers’ project / configuration / program code remains invalidated and functional tests undocumented. During the development of the Tarqvara GMP Monitor system, a comprehensive Computer Validation, including software validation, installation qualification and functional tests, is performed according to GAMP 5 guidelines. Clients receive a complete, compliant validation documentation package, and if required, additional support during GMP inspections by national and international institutions, including the FDA.

Innovative Solutions for Real-Time Monitoring of System Operations

The system performs distributed real-time monitoring of modules operation. This allows stable system operations to be maintained e.g. in case of hardware failure. System modules monitor each other to ensure their correct operation. If one of the modules fails, it is restarted by the other healthy modules. Thus a failure in one module does not interfere with the operation of the system as a whole, and full functionality is restored after 10-20 seconds.

Reports and Data Export

Reports generated by the Tarqvara GMP Monitor system can contain any numerical, textual and graphical information requested by clients, archive values of selected channels for any time period in the form of curves and tables, log records, channels settings, information about channels, registered user accounts etc. A report can be printed out, saved in PDF format, or exported into a MS Excel-compatible .csv file.

Efficient and Reliable Network Architecture

In contrast to most monitoring systems that typically have a centralized architecture, the Tarqvara GMP Monitor uses a distributed architecture. This allows the total cabling length and the cost of the system as well as its running costs to be considerably reduced. Data from sensors is transmitted in digital form to node gates and the server station, thereby excluding any influence on the transmitted parameters by factors such as electromagnetic interference, cable length and temperature.

see also:
GMP Monitoring Systems
IT Solutions / GAMP / Data Integrity (RDI)
Computerized Systems Validation (CSV)