Pharma Biotech

Pre-Packaged LIMS for Pharmaceutical/Biotech

LabVantage Pharma is the world’s only pre-validated and pre-configured pharmaceutical LIMS. This dramatically reduces the deployment time (75%) and cost (85%) compared to a traditional LIMS implementation, while providing – out of the box – the workflows and functionality required by pharma and biotech labs. That includes batch management, stability testing, consumables management, environmental monitoring, barcode label printing, and more.

Decades of experience implementing LIMS in the pharmaceutical industry are behind the creation of LabVantage Pharma.

Who Should use LabVantage Pharma?

LabVantage Pharma is the ideal solution for labs with:

  • Immediate need for operational, fully functional, validated LIMS
  • Desire to fully leverage GAMP 5 industry best practices
  • Preference for rapid, reduced-risk deployment
  • Limited resources to tackle a traditional LIMS implementation
  • Strict budget that requires low total cost of ownership (TCO)

Solution Speeds Implementation and Significantly Reduces Costs

Save up to 85% in implementation costs and 75% in time

Why spend 12 months or longer implementing a traditional LIMS – with much of that time configuring, customizing, and validating the system – when you can deploy LabVantage Pharma in a fraction of the time?

LabVantage Pharma can go live in as little as 90 days. We made the deployment process faster, smoother, and less risky with a pre-validated, pre-configured LIMS built better just for pharma and biotech labs. Built on the foundation of LabVantage 8, the most modern LIMS available, LabVantage Pharma is pre-validated according to GAMP 5 guidelines.

LabVantage Pharma FAQ

LabVantage Pharma acts as a project accelerator by saving time and costs in two areas: configuration and validation. Since we used best-practice pharmaceutical user requirements to pre-configure the solution, customers can go live with minimal configuration changes. The implementation, therefore, focuses on training your team on the pre-configured solution and helping you gather and load the master data needed to operate the LIMS. By closely adhering to GAMP 5 guidelines, LabVantage Pharma easily integrates into your existing validation processes, minimizing and streamlining the effort to validate the LIMS.

LabVantage Pharma is the only pharmaceutical LIMS solution on the market that provides complete documented evidence of previous validation execution. Pre-validation 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.

Other LIMS vendors do not provide fully executed validation, but instead supply only validation test scripts. These scripts then need to be rewritten to match the configuration and then executed. This adds substantial cost and likely does not cover the entire validation from the customer end. When you purchase LabVantage Pharma, you get complete evidence of the validation process for out-of-the-box platform.

LabVantage Pharma is the complete package for pharmaceutical and biotech quality laboratories. It includes everything needed to get your new, validated LIMS up and running quickly:

Software and Validation

  • LIMS software preconfigured specifically for pharmaceutical industry
  • Comprehensive and ready to use validation package
  • Complete documented evidence of validation pre-executed by LabVantage
  • Typical user roles and security definitions
  • Reports commonly used (e.g. Certificate of Analysis)
  • Barcode Labels
  • Template document for mapping of customer products into LabVantage

Services

  • System installation and setup – including full IQ testing in your environment
  • Time to configure for customer specific business processes
  • Master Data loading assistance for up to five product definitions, including test methods, specifications and stability protocols
  • Role specific training for administrators and key personnel
  • Complete project-specific methodology based on the Project Management Institute’s Project Management Body of Knowledge (PMBOK)
  • Comprehensive communication plan, including weekly status reports, risk and change management, project plan and more

LabVantage Pharma leverages LabVantage 8 – a 100% web-based, enterprise 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

LabVantage Pharma is validated to the most recent software version. In addition to the product deliverables, the package includes:

  • User Requirements that cover common industry processes and reporting
  • Validation Master Plan developed and approved by quality and validation professionals
  • Test Strategy with fully executed verification scripts (IQ/OQ/PQ)
  • Comprehensive handover of the operational system including Requirements Trace Matrix, Test Summary, Validation Summary and System Release Memo
  • Complete set of LIMS-specific Standard Operating Procedures including system security and change control management
  • Copies of original unexecuted test scripts for re-execution and/or modification by the customer
  • Documented qualifications (CVs) of professionals who created and executed the validation
  • And more

Where can I learn more about LabVantage 8?

LabVantage 8 provides out-of-the-box support for quality control labs. LabVantage lets you manage the sample lifecycle, optimize laboratory execution, perform data retrieval, interface instruments and systems, and enable security and auditing.

LabVantage 8