LabVantage Pharma

LabVantage Pharma

LabVantage Pharma is a pre-validated version of LabVantage Enterprise, ideal for quality laboratories in a regulated environment. LabVantage Pharma provides everything a pharmaceutical laboratory needs to get up and running quickly with a fully operational and validated LIMS.

Key capabilities of LabVantage Pharma

Pre-validated LIMS

LabVantage Pharma is pre-validated, which means it has already gone through a full execution of the validation life cycle based on User Requirements, from IQ/OQ/PQ, to System Release. LabVantage Pharma is preconfigured based on industry best practices to support pharmaceutical specific workflows, such as batch management, stability testing, reagents and standards management, and barcode label printing. LabVantage Pharma comes with complete evidence of the validation process for out-of-the-box platform.

Speeds implementation and reduces costs

LabVantage Pharma saves time and costs in two areas, configuration and validation. Since the solution is configured with  common pharmaceutical user requirements, customers can use the system with minimal configuration changes. Offered as a pre-packaged solution, LabVantage Pharma acts as a project accelerator. The implementation focuses on training on the configured solution and in helping gather and load the master data needed to operate the LIMS. By closely adhering to GAMP 5 guidelines, LabVantage Pharma easily integrates into existing validation processes, minimizing and streamlining the effort to validate the LIMS.

Pharmaceutical-Specific Functionality

LabVantage Pharma is a 100% web-based LIMS. It complies with Title 21 CFR Part 11 regulatory requirements and is developed, tested and maintained using a quality system based on IEEE standards for software quality. The solution includes the following functionality:

  • Lot and batch management (complete lot genealogy and quality dispositioning)
  • Stability testing and inventory management
  • Full sample life cycle management
  • End-to-end workflow with reporting and charting
  • Dashboards and widgets
  • Label printing
  • Management by exception using automated calculations and specification checking
  • Work review routing and sign off
  • Consumables inventory tracking including reagents and standards
  • Instrument calibration, certification and maintenance
  • Tracking analyst training, certification and qualification
  • Scheduling of environmental monitoring samples

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