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LIMS software for pharma and biopharma laboratories
A pharma LIMS for every step of drug discovery, development, and manufacturing
Critical to the successful manufacturing of a drug is the quality and integrity of the research and development studies that came before it. Laboratory Information Management Systems (LIMS) ensure that data is captured, tracked, and maintained throughout the entirety of your drug discovery, development, bioanalytical, and manufacturing processes. Thermo Fisher Scientific is uniquely positioned to support your business from initial research studies, to bioanalytical development, product manufacturing, and clinical trial analysis.
LIMS software in pharmaceutical labs have different requirements depending on the specifications of the lab. Drug discovery and development requires organizations to be agile in managing diverse types and volumes of data. LIMS for pharma R&D labs require more flexibility, while LIMS for pharma QA/QC labs require a strict adherence to SOPs and regulatory compliance. Pharma LIMS software available from Thermo Fisher are designed to meet the needs of your pharma lab. Selecting the right informatics capabilities to drive your unique drug R&D pipeline can shorten research cycles, and boost your program’s efficiency. Accordingly, our LIMS for pharmaceutical labs have been designed with these different lab environments in mind. Whether you’re developing drug candidates, synthesizing small molecule scaffolds, mutating cell lines to create new biologics, or in the process of bioanalytical studies or manufacturing, we have LIMS solutions tailored to your needs.
Research and development LIMS
It can be a challenge to find a laboratory informatics solution that can support the many different scientific workflows that exist within pharmaceutical research and development. Utilizing a LIMS throughout research and development studies helps to ensure that your valuable intellectual property is documented and maintained in a safe and secure location. Thermo Fisher offers a LIMS solution that can provide capabilities for sample and inventory management, sample preparation and analysis, instrument and software integration, and workload management across many different types of R&D workflows, such as molecular biology, genomics, biobanking, purification, and formulation.
Bioanalysis LIMS
Thermo Fisher offers a LIMS solution specifically built and designed to support the bioanalytical workflow. The informatics software can support your bioanalysis studies from method development and validation through study close out and final reporting, including integrations with laboratory software and instrumentation. The software helps to ensure that studies are conducted according to industry regulations including 21CFR58 (GLPs) and 21CFR11. Thermo Fisher’s LIMS solution for bioanalysis is relied on by many of the top pharmaceutical and contract research organizations around the world.
Process development and manufacturing LIMS
The challenges in pharmaceutical process development, quality control, and manufacturing lie mainly in achieving and maintaining compliance to regulations such as FDA 21 CFR Part 11, ISO 17025 and GxP, and in ensuring and demonstrating data integrity. A complete, connected laboratory solution comprising LIMS, LES (Laboratory Execution System) and SDMS (Scientific Data Management System) drives compliance and data integrity by clearly showing the route of data throughout all processes. Demonstrate process integrity through step-by-step electronic SOPs in LES connecting directly to a LIMS.
Instrument and system integration
Flexible integration and data visualization capabilities are the foundation of the connected laboratory. Building a laboratory ecosystem that connects people, instruments, consumables, and software requires the right capabilities and tools. Thermo Fisher combines a complete suite of integration tools with expertise in connectivity, data visualization, e-commerce, services, and infrastructure, helping you uncover the hidden value of your data.
Electronic Lab Notebook (ELN) capabilities
Thermo Scientific Core ELN software is a flexible electronic laboratory notebook (ELN) for capturing, analyzing, managing, and sharing vital scientific data and information. Quickly and easily build notebooks, entries, and sections to meet the needs of your laboratory. Data can be assembled into an experiment from external data systems, spreadsheets, presentations, and documents. Collaborating and sharing data is made easy by utilizing Core ELN software.
Sequencing/Genomics
Track genomic data across various workflows, turning large amounts of data into digestible information that can enable decision making. Genomic data can be captured and tracked easily and accurately from sample accessioning to final report generation, helping to optimize outcomes.
Small Molecule Discovery
Track specimen information from sample draw through accessioning, analysis, reporting, shipment, storage, archiving, and destruction. Tracking the entire life cycle of a sample provides scientists with a 360° view of sample data, enabling quick and informed decision making.
Biobanking
Advanced laboratory information management systems (LIMS) manage biospecimen locations, online request management, data compliance and security, instrument integration, chain of custody, patient demographics and client billing.
Biologics
Manage relationships from initial sample creation to final product manufacturing. Follow your sequence through PCR, cloning, and expression. View vector information, including details like sequence and selection markers. Track mutations, cell lines, monitor protein expression and characterization, and more.
Bioanalytical
Bioanalysis is an integral part of pre-clinical and clinical drug development. Make your assay validation, sample analysis, sample tracking, and results reporting more efficient.
Pharma QA/QC Solution
A LIMS purpose-built for pharmaceutical manufacturing and QA/QC laboratories connects multiple labs, disparate instruments and varied workflows, and integrates with existing enterprise systems. The pharma qa/qc solution delivers industry-standard capabilities including dissolution, retains sample management and stability testing as well as a unique review module built to expedite review and approval.
Vaccines/Immunizations
Selecting the right informatics capabilities can be key to driving your R&D pipeline, shortening research cycles, and boosting your program’s efficiency. Implementing our LIMS software for vaccine development can help improve speed to market, quality, and operational productivity/efficiency.
Sequencing/Genomics
Track genomic data across various workflows, turning large amounts of data into digestible information that can enable decision making. Genomic data can be captured and tracked easily and accurately from sample accessioning to final report generation, helping to optimize outcomes.
Small Molecule Discovery
Track specimen information from sample draw through accessioning, analysis, reporting, shipment, storage, archiving, and destruction. Tracking the entire life cycle of a sample provides scientists with a 360° view of sample data, enabling quick and informed decision making.
Biobanking
Advanced laboratory information management systems (LIMS) manage biospecimen locations, online request management, data compliance and security, instrument integration, chain of custody, patient demographics and client billing.
Biologics
Manage relationships from initial sample creation to final product manufacturing. Follow your sequence through PCR, cloning, and expression. View vector information, including details like sequence and selection markers. Track mutations, cell lines, monitor protein expression and characterization, and more.
Bioanalytical
Bioanalysis is an integral part of pre-clinical and clinical drug development. Make your assay validation, sample analysis, sample tracking, and results reporting more efficient.
Pharma QA/QC Solution
A LIMS purpose-built for pharmaceutical manufacturing and QA/QC laboratories connects multiple labs, disparate instruments and varied workflows, and integrates with existing enterprise systems. The pharma qa/qc solution delivers industry-standard capabilities including dissolution, retains sample management and stability testing as well as a unique review module built to expedite review and approval.
Vaccines/Immunizations
Selecting the right informatics capabilities can be key to driving your R&D pipeline, shortening research cycles, and boosting your program’s efficiency. Implementing our LIMS software for vaccine development can help improve speed to market, quality, and operational productivity/efficiency.
Research and development
Track and manage data across samples, assays, processes, requests, inventory and data throughout the therapeutic discovery and development processes.
Manufacturing
Connect stability study, environmental monitoring, content uniformity and dissolution testing results to ensure batch and continuous release product quality.
Sample management / accessioning / tracking
Good sample management processes are necessary to ensure sample integrity, data quality, and proper chain of custody. Sample management capabilities include shipment management, accessioning, and inventory management.
Instrument management
Monitor the status of the lab’s instruments, schedule work and maintenance. Manage storage capacity and freezers across facilities to maintain environment requirements for solutions, reagents, samples, etc., to ensure that they remain in the proper conditions.
Inventory management
Inventory and storage management functions retain where items have been stored and for how long. LIMS software manages stock supplies and reagents and can assign automatic reorder alerts.
Laboratory management
Understanding the overhead and capacity that your team can support is key to determining timelines, reporting on turnaround times, and resourcing projects. See a complete overview of samples that are queued and their status.
SOP compliance
Workflows guide analysts through each step of a method to ensure compliance to the SOP and captures the complete process history. Drive quality and compliance through repeatable execution of methods and processes.
Workflow capabilities
Quickly configure workflows which map to your unique laboratory processes to automate decisions and actions. Workflows simplify the initial system configuration and deployment and enable laboratories to easily adopt new methods and process changes.
Lab automation
Instrument control for liquid handling and synthesis work stations including Thermo Fisher and other vendors.
Collaborative work environment
Collect and share data securely in real-time with collaborators in your lab or across the globe.
Enterprise connectivity
Connect SampleManager LIMS software to Enterprise Resource Planning (ERP) systems, Manufacturing Execution Systems (MES), Electronic Lab Notebooks (ELN), and CDS.
Cloud or on-premises deployment
Deploy SampleManager LIMS using your own or a Thermo Fisher-managed infrastructure, including servers, operating system and database, data backup, disaster recovery, and information security monitoring, reducing initial hardware and ongoing IT costs.
Compliance
Secure system access and controls to enable compliance with the latest industry regulations such as GMP, ISO 17025 and FDA 21 CFR Part 11.
Security
Cybersecurity is critical to ensure data integrity and business continuity. Ensure secure data and system access on premises or in the cloud.
Native mobile application
Access SampleManager LIMS and LES via a tablet. Take the LIMS with you to strengthen data integrity in and out of the lab.
Data visualization
Out-of-the-box dashboards display key business and laboratory insights, including resource availability, stock information, location status, and lab performance — all in a clear interactive format. Connections via oData to Tableau Software and Microsoft Power BI and other platforms, deliver powerful knowledge from data stored in SampleManager LIMS.
Reporting and data analytics
Information in the LIMS can be reported on, shared, analyzed, and audited. All relationships and metadata are captured, enabling users to work with data in context.
Data archival
Ensure proper electronic records retention and data archival to comply with the latest regulatory requirements.
Enabling high throughput drug discovery at Amgen with Thermo Fisher Platform for Science Software
Providing pharmaceutical customers with a leading, comprehensive informatics solution with a low cost of ownership and high return on investment
Providing pharma and biotech companies, diagnostic laboratories, and contract research organizations with specific capabilities to manage specimen integrity
Drive process compliance and enable electronic management and execution of SOPs
Define, capture, and manage your laboratory data across workflows
Enabling high throughput drug discovery at Amgen with Thermo Fisher Platform for Science Software
Providing pharmaceutical customers with a leading, comprehensive informatics solution with a low cost of ownership and high return on investment
Providing pharma and biotech companies, diagnostic laboratories, and contract research organizations with specific capabilities to manage specimen integrity
Drive process compliance and enable electronic management and execution of SOPs
Define, capture, and manage your laboratory data across workflows