Pharmaceutical
& Biotech LIMS

Transform Drug Development with one LIMS

Designed for the highly complex processes of drug discovery and development, the STARLIMS Pharmaceutical and Biotech LIMS software solution handles the product lifecycle, from R&D to production to quality assurance. No matter the phase, STARLIMS allows your team to focus on the science that matters and reduces the time to bring new products to market. 

Manage an Efficient Sample and Product Lifecycle

• Effectively manage your batches, from creation to delivery of a final Certificate of Analysis (COA). Control the tests performed on batch samples based on the frequency of testing and prior test results
• Create recipes and batches associated with recipes. Download the formulation management application brochure (PDF, 386 KB) for capability details
• Manage protocols, sample inventory, studies, pulling schedules, conditions, and locations to achieve your stability management goals
• Automatically schedule sampling points and QC samples based on multiple criteria and on hourly, daily and annual schedules   
• Configure triggers, sample points, re-sample and re-test workflows
• Outsource tasks with third-party (internal or external) laboratories

Access, Review and Assess Results

• Create control charts and configure rules to track within the chart. Rule violations can be automatically detected to drive further actions on samples and tests
• View trends and observe patterns in sample results over time in a graphical format
• Automate routine data analysis and complex calculations
• Generate worksheets, result calculations and specification comparisons

Enhance Quality Processes

• Reduce quality assurance review and release processes. The release by exception concept allows all “within spec” testing to be released automatically. Flagging features alert users when something is out of the ordinary and needs additional review
• Ensure that all scheduled samples are properly collected and tested with the environmental monitoring module
• Efficiently manage sample points using visual floor plans

Have Confidence in Compliance and Best Practices

• STARLIMS has been designed to help your organization comply with a wide range of different regulatory standards, including FDA 21 CFR Part 11 and the EU Annex 11 guidelines, ISO 17025, ISO 13485, ISO 9001, and cGxP
• Access an entire sample history, display full audit trails, extract e-signature information, and much more
• Track and manage analyst training and certifications for tests and methods, and schedule courses and re-certification
• Manage chain of custody with electronic signatures 

Streamline and Automate Day-to-Day laboratory Logistics

• Assign work to analysts and equipment based on availability and workload
• Interface to several systems for lab data sharing, including third-party systems SAP, Empower, Chromeleon, and other internal enterprise systems
• View key performance indicators, including bottlenecks, sample turnaround times, and out-of-specifications samples to make resource decisions
• Manage the storage of samples and storage locations. Store your samples in hierarchical storage containers and view the contents of each level of the storage hierarchy
• Configure how often to archive data based on internal retention policies and schedules 
• Manage suppliers of raw materials and laboratory consumables
• Manage customer information, and set up projects for laboratory testing, including test pricing, invoicing, and schedules for sampling and testing

Besides manufactures who are creating molecular products for use within the industry as well as the life sciences research and clinical fields, molecular processes are becoming more commonplace in the Biopharmaceutical industry and not just during the research and development phase. One of the most complex molecular processes, Next Generation Sequencing (NGS) is turning into an opportune tool for the characterization of biological products, such as viral vaccines, cell lines, final drug products. At the same time instruments that create oligonucleotides are being utilized to create molecular tags used in other molecular assays and more recently to molecularly label manufactured products, for the ultimate identification of product origin. Having a LIMS that can track the manufacturing process from start to finish and include the molecular functionalities provides traceability of the product and source materials and quality metrics. 

Manage efficient sample and batch testing 

• Support sample and test workflow from start to finish, configure triggers, sample points, re-sample and re-test workflows 
• Manage molecular protocols, where existing workflows can be used as templates for new protocols, where reference ranges, and reporting requirements can be configured
• Evaluate sample test results against different sets of specifications and control the progress of the sample or batch through its lifecycle

Streamline day-to-day lab logistics 

• Direct samples to equipment and workflows based on availability and schedules
• Interface to automated specimen handling systems and analytical instruments, system-to-system communications via web services, file transfer (text, CSV, HL7, ASCII, etc.), and direct database communications
• Manage the storage of samples and batches of samples and sample storage locations

Choose from available workflows or design your own 

• Select from pre-existing standard workflows or modify workflows for your needs to perform sequencing, mutation analysis, or expression analysis
• Create workflows for manufacturing oligonucleotides
• Share protocol details among workflows

Have confidence in compliance and best practices

• STARLIMS has been designed to help your organization comply with a wide range of different laboratory regulatory standards, including FDA 21 CFR Part 11 and the EU Annex 11 guidelines, ISO 17025, ASCLD-LAB, CALEA, cGXP and other accreditation standards including newest 18 CAP checklist requirements  
• Comply with ISO 17025, often the basis for gaining industry recognized accreditations (i.e. National Environmental Laboratory Accreditation Program (NELAP), International Laboratory Accreditation Cooperation (ILAC), American Association for Laboratory Cooperation (A2LA)

Manage samples, materials and equipment 

• Manage all molecular materials, inventory items and consumables and their associated workflows
• Manage molecular equipment lists, scheduled maintenance events, calibrations, and QC standards
• Allow QC standards to be used in multiple workflows
• Manage the storage of samples and storage locations. Store your samples in hierarchical storage containers and view the contents of each level of the storage hierarchy

Integrate with multiple labs

• Be able to integrate workflows between multiple laboratories providing the ability for an audit trail of one sample across multiple laboratories

The STARLIMS Molecular functionality incorporates seamlessly into your laboratory workflow to allow for a single system to manage the complexity of molecular sample and specimen processing.

The STARLIMS Automated Validation Framework and Testing Kit (for use with STARLIMS QM 12.1) is a comprehensive testing suite that is used to verify the STARLIMS core software functionalities for each setting and deployment. This essentially provides the LIMS customer with a set of tools that can be used for various aspects within their validation process.

Learn more about STARLIMS Automated Validation Framework and Testing Kit.