Pharmaceutical Industry
The pharmaceutical industry is characterized by intense competition on a growing market. Expiring patents and strict regulations and policies increase the pressure to improve production efficiency and meet high quality standards at the same time. Traceability, reproducibility, and safety are key factors to success. Quality assurance is no longer a separate stage at the end of the production but is integrated into the processes for continuous improvement. VisiWin provides a powerful system that allows not only to control, observe, and monitor processes but also to securely record the relevant data.
Reproducibility
Manufacturing processes in the pharmaceutical industry are complex and depend on many parameters, validating them being a time-consuming procedure. As a result, reproducibility of the validated process presents a major challenge. The VisiWin recipe management system allows you to group the parameters logically and save them in recipes. The operator can use VisiWin UI elements to load and save a recipe as well as to read a recipe from and send it back to the PLC. Since such interactions have an immediate effect on the process, requirements on recipe management systems are particularly demanding in the pharmaceutical industry. Access must be logged and changes versioned, recorded, and stored in a forgery-proof manner. The VisiWin recipe management also includes an integrated version history and allows forgery-proof storage by using various security mechanisms.
More information: Recipe management
The pharmaceutical industry is a global industry characterized by a large number of international cooperations. Process reproducibility must be ensured in different linguistic environments. The VisiWin language switching system allows you to achieve this. Not only does it manage notifications, menu titles, and button labels in the form of texts, but it also allows to switch units and date formats. What’s more, country-specific keyboard layouts can be switched at a push of the button. The entire operator interface with all its components can be translated into the language of the end customer’s country, and the UI language can be switched at runtime.
More information: Language switching
Quality
Errors and malfunctions occur for various reasons. To correct or repair them quickly, critical machine states must be made visible. The VisiWin alarm management achieves this using alarm classes of varying importance. Alarm classes may encompass errors, warnings, notifications, or any other classes you prefer. The expected reaction is configurable, too. An alarm can be just deactivated or needs to be acknowledged by a second person before it is turned off. Alarms and alarm state changes are saved in a history for later analysis. This allows to improve maintenance and to minimize machine downtimes if appropriate measures are taken in a timely manner.
For a fast detection of malfunctions and their causes, VisiWin allows to group alarms, thus associating them with individual machine parts. The main objective with any malfunction is to quickly solve the issue and prevent it from recurring. VisiWin provides you with the necessary tools to do that.
More information: Alarm management
For many process parameters, not only the current values are relevant but also their development over time. Trend curves and diagrams are well suited for this. VisiWin allows to record values at shorter or longer intervals, temporarily in the working memory, or permanently in archive files. These archives can be saved once a day or batchwise, for example. Limit values can be defined in the VisiWin trend recording system so that users can detect any abnormalities early and take countermeasures. Moreover, the diagrams allow to select and scale trend curves at runtime. The charts also include zoom and scroll functions for a detailed inspection. They react to gestures if a multitouch monitor is used. To facilitate analysis, the user can generate trend curve reports with integrated alarm statistics.
More information: Trend recording
Safety
In many countries, the pharmaceutical industry is subject to strict regulations regarding traceability and quality assurance. Title 21 CFR Part 11 of the Code of Federal Regulations specified by the United States Food and Drug Administration (FDA) and Annex 11 of the EU GMP regulations (Computerized Systems) are two of the major regulations that apply to validation of computer systems in regulated, pharmaceutical sectors. If a machine is operated in a country where these regulations apply and where the pharmaceutical products are marketed, compliance with these regulations must be confirmed by an inspector prior to production start. For example, Title 21 CFR Part 11 includes stipulations on electronic data management and signatures and therefore affects digital logging in control and monitoring software. VisiWin includes powerful features to allow that. The user management and logging systems are two of them.
The user management system includes functions to protect processes from unauthorized modification and to allow access to sensitive data to authorized personnel only. With the help of the VisiWin user management, individual functions can be hidden or deactivated for this purpose. High protection can be ensured by the numerous password options. These options include expiry periods, encryption, conditions, and blacklists for passwords. Login procedures include RFID readers and biometric methods, which can be used for electronic signature. Electronic signatures according to the dual control principle are another important feature directly supported by VisiWin.
More information: User Management
A valid production requires secure logging. Events must be recorded and saved in a forgery-proof manner. VisiWin allows to define events that will be logged. These events include system events such as start and stop or user login and custom events such as page switching. In accordance with an FDA-compliant audit trail, all data related to process intervention are recorded. These data include user data, events such as fault messages, local and UTC time stamps, as well as comments and notes. The data are saved in files that are closed, stored, or rewritten at specified times of the day or when there is a batch change. User-defined reports can be generated from the recorded data for process analysis.
More information: Logging
VisiWin has many more features for your HMI/SCADA solution: Functionalities
VisiWin is used by many players in the pharmaceutical industry and grows constantly in close cooperation with our customers.
Packing With the IWK HMI
A standardized HMI for a group of companies with different types of machines – such was the goal of this award-winning HMI project. IWK used VisiWin to develop a new HMI with an advanced visualization for their machines.
