Transform into a digital lab and accelerate biopharmaceutical development.

• Lot Management

  LabWare LIMS organizes the tracking, testing, and reporting of batches and lots to maximize laboratory efficiency. Track the status of all batches/lots tested from submission to reporting, with built-in laboratory KPIs, data review functionality, lot release functions, automatic COA report generation, and approvals for each lot.

• Certificates of Analysis

  By automating data collection, analysis, and reporting, LabWare ensures accurate and consistent documentation of product testing results, and providing traceability to raw data, enhancing compliance, and expediting the generation of comprehensive and reliable CoA for regulatory purposes.

• Environmental Monitoring

  LabWare provides flexible and reliable controls for managing sampling and testing. Schedules can be programmed into the system to automatically log samples and prompt regular point monitoring, ensuring all the required samples are collected and tested appropriately. Samples can also be handled manually to facilitate unscheduled sampling or personnel monitoring.

• Stability Management

  Highly flexible Stability Study Management capabilities coordinate and manage all related work in a study with one or many protocols. LabWare functionality includes inventory and storage location management, stability pulls, work assignment, sample chain of custody, results entry, review, and reporting.

• Laboratory Inventory

  LabWare facilitates efficient and accurate management of laboratory inventory by providing real-time tracking, centralized control, and automated documentation of reagents, standards, solutions, consumables, and other items used throughout biopharmaceutical testing.

• KPI Dashboards

  The dashboards used to drive many of the processes within LabWare contain appropriate graphical and tabular representations of the process being performed.

  The Key Performance Indicator dashboard contains measures to aid with the efficient operation of the laboratory.

  These graphical and tabular metric tools are fully configurable, ensuring the information you need to operate your laboratory is at your fingertips and the KPIs you’ve defined for your processes are built into your dashboards and constantly reported in real-time, ensuring the data you want is the data you see.

• Regulatory Compliance (21 CFR Part 11, ISO 17025)

  The LabWare LIMS and ELN platform are fully compliant with all technical controls of industry regulations, such as 21 CFR Part 11 (Electronic Records and Electronic Signatures), GMPs, and regulatory requirements from many international regulatory agencies. The LabWare Platform has an extensive audit trail and can be configured very easily to support your company’s interpretation of audit reason prompting and if appropriate electronic signature.

  ISO 17025 defines the general requirements for the competence of testing laboratories. LabWare supports your laboratory’s compliance with Document Management, Training Management, Investigation Management and Uncertainty Measurement features.

• Integrated ELN

  LabWare's integrated electronic laboratory notebook provides additional capability to manage large data sets in plate-based testing and flexibility to document research experiments.