GMP compliant programming of synthesis projects
Modular-Lab Software is the renowned standard software solution coming with all Modular-Lab synthesis systems. All versions have a self-explanatory graphical user interface and support the compliance of your process with the highest standards of GMP, cGMP, GAMP 5 and 21 CFR part 11 regulations.
Modular-Lab is the renowned standard software solution coming with all Modular-Lab Standard, Modular-Lab PharmTracer and Modular-Lab eazy systems. Each Modular-Lab synthesis device will be completely controlled and run by the software.
It comes in open as well as closed versions. Closed versions (as used with Modular-Lab eazy) are non-editable and only support the use of pre-validated synthesis projects requiring a dedicated system setup. A wide range of according projects for different tracers is available via Eckert & Ziegler.
The open, editable software version (available for Modular-Lab Standard and PharmTracer) furthermore allows programming and creation of project templates for the development of own synthesis processes. The software works with an intuitive graphical interface to create projects by drag and drop of symbols. The editable Modular-Lab Software versions require the use of a Dongle license in order to access and run the program.
The Modular-Lab software features allow you to design you process in a way that complies with the highest standards of GMP, cGMP, GAMP 5 and 21 CFR part 11 regulations. An access control with four defined security levels (user, service engineer, project manager, and administrator) meets all demands for the security of the process data and the application-specific setup. The logging of all system and user operations runs fully automatically.
Additional features include:
Audit Trail and Reporting
The implemented audit trail function records all necessary information including process data (process steps, sensors), user data (user management, login, etc.), downloading of programs as well as occurring errors and messages.
The tracked data including time stamps is available as a comprehensive batch report (PDF file) after the end of a process.
Apart from the basic software and programming training during the installation of your Modular-Lab, Eckert & Ziegler upon request offers additional synthesis and software trainings to refresh your knowledge or incorporate new colleagues. All trainings can be tailored to your demands. Contact us for more information.