Pharmaceutical
What pressures are driving your business?
Pharmaceutical companies continually search for ways to reduce the cost of business while ensuring quality. This industry is under ever-increasing pressure to bring new drugs to market, faster, and more cost effectively. Intense competition, regulatory compliance, expiring patents, and healthcare expenses all drive the need to constrain costs. In pharmaceutical manufacturing or R&D you may be facing the need to:
- Reduce cost of business
- Improve manufacturing quality
- Reduce time to product release
- Introduce new products
- Expand your business
- New, advanced technologies
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- Staff reductions
- Comply with more regulatory requirements
- Withstand audits
- Migrate from legacy LIMS
- Standardize on one LIMS system across your enterprise
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Keep competitive with the SQL*LIMS® Software solution The LIMS software you chose is essential to meeting your goals in controlling costs and improving pharmaceutical laboratory efficiency and productivity. LabVantage Solutions understands the issues you face. That’s why nine out of the top 10 pharmaceutical companies have chosen SQL*LIMS Software.
SQL*LIMS is a complete, 100% Web-based informatics solution from a trusted laboratory information management system (LIMS) provider and partner. This comprehensive solution integrates, automates, and manages laboratory data and workflow processes for pharmaceutical and other R&D and manufacturing QA/QC operations.
Core functionality for the pharmaceutical industry SQL*LIMS Software integrates the following core functions into a commercial-off-the-shelf configuration tailored to pharmaceutical QA/QC.
- Lot and batch management
- Quality assurance
- Stability studies
- Core analytical laboratory management
- Environmental monitoring
- Connectivity to laboratory instrumentation
Commercial off-the-shelf configuration for pharmaceutical QA/QC
- Includes hardware and software
- Pre-configured and pre-qualified for pharmaceutical QA/QC
- Spend less time validating
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- Reduce validation costs
- Speed LIMS implementation
- Reduce cost of ownership
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The core functionality of the SQL*LIMS Software combined with function-specific modules such as SQL*QA™ and SQL*Stability™ Software provides a complete, integrated solution for pharmaceutical customers. This reduces the need for customization during and after installation, and it streamlines the implementation and validation of the SQL*LIMS Software, which are important goals in controlling costs and improving pharmaceutical laboratory efficiency and productivity.
With this first true plug-and-play solution, our pharmaceutical customers can order a complete pre-configured, pre-qualified system for pharmaceutical QA/QC. This solution includes both the hardware and the Oracle database. The software is pre-configured for a typical lab with USP methodology for product content uniformity/dissolution testing and ICH standards for stability testing built in. The system also includes documented IQOQ (Installation and Operation Qualification) testing already completed on the box.
For many customers, the cost of customizing and validating a LIMS system to meet regulatory compliance exceeds the cost of the system itself. This is especially true for companies with a small (or non-existent) IT staff. With our pre-configured systems, much of this work is already completed before delivery, reducing the both the time and cost associated with implementation, customization, and validation.
How SQL*LIMS can benefit your laboratory workflow processesSee how SQL*LIMS Software can make you more productive throughout your laboratory processes. Select the image below and see how you can use SQL*LIMS Software in the workflow of a regulated laboratory. For a more in depth demonstration, you can also select
Take a Tour.
Key features & benefits
Flexible, Cost-Efficient Architecture
100% Web-based system is easy to deploy, maintain, upgrade, and integrate into enterprise business systems
- Scalable, flexible, open architecture
- Easily tailored to meet the needs of both small and large multi-site global operations
- Multi-site deployments are simplified with this flexible, configurable system
- Enables you to build and extend functionality to meet your complete needs for e-commerce and Web messaging
Easy Navigation
- Laboratory processes are simplified using easy-to-configure workflows and reporting tools
- Streamline, one-mouse click navigation for easy access to LIMS functions
- Information is immediately available
- No need to click through icons or folders to find information
- Enhanced fill-down, pop-ups for data entry and approvals
Validation Support
- Validation-ready implementation. The existing rich functionality and feature set reduces the time need to configure, test, and deploy the system. Little to no custom code needs to be developed for the typical implementation. This lowers the overall project timeline and dramatically reduces the validation requirements.
- A full set Structural Validation documentation is made available with every release of SQL*LIMS. This documentation set provides a comprehensive software test suite and full electronic documentation.
- The SQL*LIMS Professional Services team also offers validation services to make validation easier than ever
Regulatory Support
- Assists with FDA 21 CFR Part 11 ERES/EDIG compliance requirements
- Manufactured in strict accordance with ISO 9001:2000 quality system guidelines
- Designed, tested, and manufactured for use in Good Manufacturing Procedures (GMP), Good Laboratory Procedures (GLP), and GxP environments.
- Independent auditors from BSI certify and document processes for customers in regulated industries.
- Internal teams audit the LabVantage Solutions Quality Program regularly
Systems Integration
- Certified integration with ERP/MRP (manufacturing resource planning) systems
- IDM-LimsLink™ is integrated into SQL*LIMS to provide instrument connectivity
- Industry-standard SSL and PKI encryption methods available for secure intranet/Internet deployment
More Functionality
- Analyst training and qualification tracking
- Glassware and reagent inventory tracking
- Ability to save and distribute commonly used queries
- Fully configurable, grid-based result entry
- Instrument calibration management
- Analyst training and qualification tracking
- Reagent/glassware inventory tracking
- Ability to save and distribute commonly used queries
- Expanded portability of our Web-based software enables customers torapidly deploy global systems and access their LIMS functions securely from remote locations or by using portable devices such as PDAs or tablet PCs
Security
- Secure single-user passwords for users of multiple databases
- Industry standard encryption for secure intranet/internet deployment
Solid, Proven Technology
- Built on the industry standard technology including the Oracle® Application Server 10g and Oracle10gi™ database
- Supports the extensible Java 2 Platform, enterprise Edition (J2EE) standards-based application