SQL*LIMS P4 Plug & Play Pharma Package

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1 SQL*LIMS P4 PLUG & PLAY PHARMA PACKAGE SQL*LIMS P4 Plug & Play Pharma Package Reduces complexity, accelerates deploying industry best practice workflows, simplifies IT Get up and running fast with a fully operational, validated LIMS at a fraction of the cost of a generic LIMS. With SQL*LIMS P4, the first true plug & play pharma package for the pharmaceutical laboratory, we ve taken everything we ve learned about laboratory information management and distilled it into a single solution.

2 The Next-Generation Commercial Off-the-Shelf LIMS A Typical LIMS Implementation 8 months months Minimum of 8 months Client Knowledge Base Template Development (3 wks) Validation (1 2 wks) Training (1 wk) GO LIVE Requirements (2 wks) System Design (3 wks) Development (3 months) Reports Status actions Templates Validation (3 months) Production IQ/OQ PQ Validation SOPs Training (2 3 wks) GO LIVE A SQL*LIMS P4 Implementation 2 months months 2 months Save up to 85% in LIMS Implementation Costs and 75% in Time with Our SQL*LIMS P4 Plug & Play Pharma Package A conventional LIMS implementation takes a minimum of 8 months at best, with most of the time spent in development and validation. SQL*LIMS P4 is preconfigured and validated to reduce implementation time and expense. A SQL*LIMS P4 implementation can be completed in as little as 2 months and uses dramatically fewer resources, for approximately a 75% savings in time and approximately an 85% savings in cost. With SQL*LIMS P4, you ll go live faster and more efficiently.

3 Plug & Play Solution Speeds Implementation and Virtually Eliminates Validation Costs SQL*LIMS P4 is a fully functional, fully configured, fully validated LIMS solution that can be deployed almost immediately. SQL*LIMS P4 is packaged with our industrystandard SQL*LIMS Software and a typical pharmaceutical or biopharmaceutical development and manufacturing operation configuration, making it the ideal choice for laboratories with: A desire to more fully leverage Industry Best Practices Limited resources to tackle a traditional LIMS implementation An immediate need for an operational, validated LIMS Key to the solution is a complete Validation Master Plan with fully executed IQ/OQ/PQ documentation and LIMS-specific SOPs. The end result: fast deployment, lower cost of implementation, and, most importantly, reduced compliance risk. SQL*LIMS P4 Advantages Dashboard The right information at your fingertips Go operational faster with our preconfigured and validated LIMS solution Reduce your total cost of LIMS implementation by up to 85% versus traditional systems Industry Best Practices to harmonize your business processes Fully supports 21 CFR Part 11 compliance The Complete Package SQL*LIMS P4 provides everything you need to get up and running quickly, including: Fully validated SQL*LIMS Software Northwest Analytical Quality Analyst for laboratory analytics Preloaded system templates for typical drug development or manufacturing operations, using Industry Best Practices Typical laboratory user roles and security definitions Common USP testing methods Stability templates preconfigured based on ICH guidelines System installation and setup Configuration assistance for up to five material definitions Test methods Specifications Stability protocols Fully validated, commonly used reports (including design, testing, and validation documentation) Role-specific end-user training and training courses for key personnel Optional remote system administration, maintenance, and support Simplify system upgrades and ongoing support Lower the total cost of ownership (TCO) Cost-effective upgrades Validated to the next version Stay up with the current versions Reduction of staff resources Maximize your return on investment in software, personnel, and time

4 Pharmaceutical-Specific Functionality SQL*LIMS P4 is built around Industry Best Practices. At its core is our award-winning SQL*LIMS Software, a web-based, complete enterprise accessible solution for drug development and manufacturing operations. SQL*LIMS P4 functionality includes: Lot and batch management (complete lot genealogy and quality dispositioning) Stability testing and inventory management (templates preconfigured to ICH guidelines) Full sample life cycle management Label printing Management by exception using automated calculations and specification checking Fully Validated System Unlike any other LIMS package, SQL*LIMS P4 arrives validated. You receive: A Validation Master Plan developed and certified by an independent validation consultant Fully executed IQ/OQ/PQ (to design process) scripts, signed and documented Original test scripts (prior to execution) Complete set of LIMS-specific Standard Operating Procedures Documented qualifications (CVs) of the professionals who executed the validation scripts Work review routing and signoff Instrument calibration and maintenance Analyst training and qualification tracking Reagent inventory tracking Comprehensive reporting and charting Complete regulatory compliance suite Dissolution and content uniformity testing (optional)

5 The Challenge of Generic LIMS Implementations Pharmaceutical as well as many biotechnology companies operate in unique and stringent regulatory environments. Validating systems for adherence to applicable regulations is necessary to ensure the safe and reliable supply of products. For many generic LIMS implementations, however, the cost of system validation often exceeds the cost of the software itself. Implementation and validation of LIMS software has traditionally been challenging because laboratory business processes are seldom well documented, and harmonization is fraught with cultural and operational hurdles. As a result, pharmaceutical and biopharmaceutical companies have traditionally spent significant time and expense during LIMS projects for system planning, design, customization, and validation (IQ/OQ/PQ). And because site-specific customizations raise the barriers to upgrading to new systems, laboratories may then feel locked in to their current systems, unable to take advantage of new functionality or technology. While challenging for everyone, this situation is especially problematic for customers with limited resources. The Solution: SQL*LIMS P4 Plug & Play Pharma Package.

6 The Gold Standard in Laboratory Information Management Since 1981, SQL*LIMS has been the industry leader in LIMS technology. Today, more than 40,000 professionals worldwide use SQL*LIMS Software, in industries as diverse as pharmaceuticals, chemical and petrochemical manufacturing, environmental science, food and beverage production, and forensic analysis. European LIMS Vertical Market Penetration Leadership Award In addition, we have an unmatched track record in managing every type of implementation, from the simplest to the most complex. SQL*LIMS senior project managers are all certified by the Project Management Institute (PMI ). Our investment in this rigorous certification process demonstrates our dedication to quality SQL*LIMS service, helping to ensure that we will manage your LIMS project to success. To learn more about SQL*LIMS P4 Business Solution, call us at in US or in Europe, us at or visit LABVANTAGE Solutions, Inc. All rights reserved. The trademarks mentioned herein are the property of LABVANTAGE Solutions, Inc. or their respective owners. Printed in the USA, 01/2011 Publication 1101JY25CYL Headquarters 1160 Route 22 East Bridgewater, NJ International Sales For our office locations please call the division headquarters or refer to our Web site at