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

MORE CAPABILITIES

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

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.

MOLECULAR 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.