Laboratory software

data managementmaintenance managementfor control

Overview
Modular-Lab Software is the standard software solution provided for Modular-Lab synthesis systems. It offers a graphical user interface designed to support compliance with GMP, cGMP, GAMP 5 and 21 CFR part 11 regulations. The software records system and user operations automatically and supports secure access control with multiple user levels.

Key Features

• Intuitive User Interface
• Editable or Closed versions available
• GMP and GAMP5 compliance support
• User Management with four access levels

Functionality
The software is provided for Modular-Lab Standard, Modular-Lab PharmTracer and Modular-Lab eazy systems and controls and runs each Modular-Lab synthesis device. It is available in open (editable) and closed (non-editable) versions. Closed versions support pre-validated synthesis projects for dedicated system setups. The open, editable version allows programming and creation of project templates using a drag-and-drop graphical interface. Editable versions require a Dongle license to access and run the program.

Features (additional)

• manual and automatic control of programmed processes
• automated database download from PLC onto notebook after each project download
• system status messages
• protection of know-how through restricted access
• barcode reader
• errors and comments associated with specific processes
• display of steps in a separate message window
• four timers with countdown function
• help function
• trend viewer
• calculation and comparison of mathematical and logical terms
• service and maintenance information

Audit Trail and Reporting
The implemented audit trail records process data (process steps, sensors), user data (user management, login), program downloads and occurring errors/messages. Tracked data with timestamps is available as a comprehensive batch report (PDF) after process completion.

Training
Basic software and programming training is provided during installation. Additional synthesis and software trainings can be provided and tailored to customer needs.

CE Conformity
CE-Conformity certificates are available.

Technical characteristics / specifications

• Product name: Modular-Lab Software
• Software versions: open (editable) and closed (non-editable)
• License: Dongle license required for editable versions
• Compliance: GMP, cGMP, GAMP 5, 21 CFR part 11
• User access levels: user, service engineer, project manager, administrator
• Audit trail: records process data, user data, downloads, errors; batch report (PDF) generation
• Interface: graphical, drag-and-drop project creation
• Controls: manual and automatic control of programmed processes
• Data handling: automated PLC-to-notebook database download after project download
• Peripheral support: barcode reader
• Operational aids: timers (four), trend viewer, help function, message windows
• Service: service and maintenance information included