LabVantage Pharma is the world’s only pre-validated and preconfigured pharmaceutical LIMS. Dramatically reduce the time and cost, typically spent on a traditional LIMS implementation, by using LabVantage Pharma, a pre-packaged solution that leverages GAMP 5 Industry Best Practices. LabVantage Pharma is the ideal solution for laboratories in need of operational fully functional, validated LIMS.
Who should use LabVantage Pharma?
LabVantage Pharma is the ideal choice for labs with:
- Limited resources to tackle a traditional LIMS implementation
- A strict budget that requires a low total cost of ownership (TCO)
- An immediate need for an operational, validated LIMS
- A desire to fully leverage GAMP 5 industry best practices
Solution Speeds Implementation and Significantly Reduces Costs
Save up to 85% in implementation costs and 75% in time
A traditional LIMS implementation can take 12 months or longer with most of the time spent in configuration, customization and validation. LabVantage has made this process faster and smoother with a preconfigured, industry-specific solution called LabVantage Pharma. The solution is built on LabVantage 8 and is pre-validated according to GAMP 5 guidelines. With LabVantage Pharma, you can go live in as little as 90 days.
How is LabVantage Pharma a pre-validated LIMS?
We used our years of experience implementing LIMS in the pharmaceutical industry to create LabVantage Pharma. This packaged solution 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. 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.
How can LabVantage Pharma be implemented so quickly?
LabVantage Pharma saves time and costs in two areas, configuration and validation. Since we used common pharmaceutical user requirements to configure the solution, 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 your team on the configured solution and in 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.
Complete Package for Pharmaceutical Quality Laboratories
LabVantage Pharma provides all you need to get your new, validated LIMS up and running quickly, including:
Software and Validation
- LIMS software preconfigured specifically for pharmaceutical industry
- Comprehensive and ready to use validation package
- Complete documented evidence of validation completed 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 to the LabVantage software fields
- System installation and setup
- 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
The solution 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 the only pharmaceutical LIMS solution on the market that provides complete documented evidence of previous validation execution. The solution 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
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.
Top companies use LabVantage
Thousands of labs across the globe use LabVantage to power their regulated laboratories and get consistent quality. Our customers span across industries and range from the Fortune 500 to startups.