Thermo Scientific - Laboratory Information Management Systems

Biotech and pharmaceutical environments (from discovery, research, CROs and manufacturing) face unique challenges and therefore require purpose-built Laboratory Information Management Systems (LIMS) tools that are very different from traditional laboratories that employ generic LIMS as their data management solution.

Laboratories that are "discovery oriented" must look to high throughput informatics and study management tools to help them:

• Screen smarter and faster
• Manage standard and complex study protocols
• Acquire, analyze and run complex calculations and statistics on huge volumes of data, in multiple formats
• Review, summarize, document and present data in effective reports
• Automate, integrate and manage equipment and data
• Accelerate decision making
• Create an information rich environment (knowledge) in order to make better decisions and sooner
• Comply to fierce regulatory requirements

Typical generic LIMS do not offer off-the-shelf functionality that address the unique needs of plate handling, study/trial management and DMPK calculations in drug discovery and research. Thermo Fisher Scientific addresses these needs head on with its rich functionality and flexible framework of Nautilus, Galileo and Watson LIMS.

NAUTILUS LIMS™

Nautilus LIMS is extremely flexible and offers significant advantages for high throughput screening laboratories that require plate handling by providing:

• Complete audit trails
• Daughter plate production
• Reformatting, re-racking and cherry picking for 96/384/1536 plate types
• Seamless integration with leading robotic solutions
• Graphical drag and drop workflow engine
• Automated workflow process capability
• A turnkey solution
• Easily connects to most major test and measurement devices
• Extensive workflow engine to address procedures, instrument sequences and business rules
• Traceability functions developed in compliance with FDA 21 CFR Part 11 standards
• Easy integration of barcodes and analytical robots
• Simple and automated dissemination of information
• Real time and historical trending of data
• Online QC on web

GALILEO LIMS™: FULLY INTEGRATED LIMS FOR IN-VITRO ADME

Galileo LIMS™ offers specific advantages over manual data processing, using spreadsheets where many or all in-vitro processes are performed manually, and data is transcribed by copy and pasting. This often entails the risk of files being misplaced or stored on a local PC and not the server.

Galileo incorporates and automates these processes allowing for standardized methods and procedures, integrated instrument interfaces and a centralized data storage area.

Galileo’s fully integrated system for in-vitro ADME includes:

• Scheduling assays and planning tasks using workflows
• Creation of unique experimental assay designs
• Calibration curve regression using Watson™ algorithms
• Extensive instrument interfacing
• Calculation of industry standard in vitro parameters
• Full graphing of analytical results
• Data status flags
• Industry standard descriptive statistics
• Integrated audit trail, e-signatures and security

WATSON LIMS™: PHARMACEUTICAL COMPANY

Watson LIMS™ is in 19 of the top 20 pharmaceutical companies around the world providing them the functionality, flexibility and scalability that meet their needs both today and in the future.

• A complete 21 CFR Part 11 compliant system and full study audit trail
• Full bi-directional interface capability to analytical instruments, tracks shipments and samples through user-designed barcode labels, supports a wide range of analyses, and organizes study results in a unique document management system
• Enterprise-wide knowledge and collaboration
• Robust, dynamic reporting and data analysis includes a regression calculation tool, and linear and non-linear algorithms

DARWIN: PHARMACEUTICAL MANUFACTURING R&D QA/QC

While the above LIMS solutions are tailored for drug discovery and research laboratories, Thermo Scientific Darwin LIMS™ is specifically designed to address the unique needs of pharmaceutical manufacturing research and development, and QA/QC labs.

Darwin's unique product oriented design aligns itself with pharmaceutical manufacturing processes, allowing the logical organisation and reporting of research and development, and production data.

By including industry specific, standard functionality, Darwin provides all the equipment pharmaceutical manufacturing labs need, in a ready to use format.

Among Darwin's industry-specific functionality, the system handles:

• Dissolution (single-point and multi-point)
• Environmental monitoring
• Stability management
• Product management
• Batch management
• System interfacing