GLP/GMP Compliance and the Importance of Data Security in Laboratory Software

Day by day, the computerized systems in our laboratories are advancing and providing us with more reliable and detailed data, while the software of these computerized systems is being developed to meet the requirements of today's technologies and to provide answers to the questions posed by authorities.

Producing correct, reliable and systematic data is as important as the factors that create this data being recordable, traceable and reportable. Additionally, since the generated data has document status, it must be stored for many years and be accessible on demand. As Ant Teknik, we have been serving many pharmaceutical laboratories in our country for years with Shimadzu LabSolutions CS systems that respond to all authorities' (FDA, PICS, etc.) security and inspection procedures. LabSolutions CS, which operates from a server and holds data from all connected devices within an 'Oracle database' on that server, prevents users from accessing and deleting data. Additionally, 'client' computers operating through this server can also be managed from a single center. Thanks to ACQ computers that control analysis applications, analysis does not stop even in the event of any server malfunction, and all data created through regular backup procedures can be copied to an environment outside the server on a daily, weekly and monthly basis. LabSolutions CS not only meets security requirements, but also provides convenience for both users and laboratory management.

From the user perspective, it first solves the complexity of maintaining separate passwords for each computerized system by applying single user management for all systems, and by positioning client computers in offices, it eliminates the necessity of using a computer directly connected to the device to learn the status of the analysis.

One of the difficulties faced by users is that they must use different software for different brand devices. In this regard, LabSolutions CS continues to add new brands and models to its device infrastructure day by day. From a management perspective, the ability to monitor information such as the project being worked on for all systems in the laboratory, who is working on the project and the status of the analysis is a time-saving and functional feature in terms of laboratory workflow. (Figure 1) The ability to access all generated data from any client computer and digitally sign this data is another important time-saving feature of the system.   If you wish, you can design LabSolutions CS server infrastructure as an open system connected to the internet and provide system access from outside the laboratory. Moreover, with the Citrix version, it provides the ability to be controlled from smartphones and tablets.(Figure 2)     In summary, having the devices in your pharmaceutical laboratory managed with LabSolutions CS software both in terms of ease of use and data security and GLP/GMP compliance, through its continuously updated and evolving structure, ensures that while your chromatographic and spectrophotometric devices are controlled with LabSolutions CS, full compliance with all relevant regulations is achieved, making this system an indispensable solution partner.

Serhan Tek / Chemist / Qualification Group Chief / Ant Teknik