LIMS FOR GENERAL MANUFACTURING

DELIVERING QUALITY IN A FAST-PACED ENVIRONMENT

Efficiently managing the testing of batch processes and ensuring that products meet defined specifications and safety requirements is critical to your organization’s success.

The STARLIMS Manufacturing LIMS solution allows your lab to monitor both batch and continuous manufacturing processes while streamlining procedures and improving automation. Integrate with other business critical systems, such as Enterprise Resource Planning (ERP) and Process Information Management Systems (PIMS) to optimize your operations throughout the entire manufacturing lifecycle and get safe, high-quality products to market faster.

ENHANCE QUALITY ASSURANCE PROCESSES TO DECREASE TIME

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 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 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 Ensure that all scheduled samples are properly collected and tested with the environmental monitoring module Efficiently manage sample points using visual floor plans

MANAGE AN EFFICIENT SAMPLE AND PRODUCT LIFECYCLE

Manage protocols, sample inventory, studies, pulling schedules, conditions, and locations to achieve your stability management goals. You may migrate your legacy stability study system into STARLIMS Configure triggers, sample points, re-sample and re-test workflows. Link to open investigations through the integrated investigation module Automatically schedule sampling points and QC samples based on multiple criteria and on hourly, daily and annual schedules Create recipes and batches associated with recipes. Download the formulation management application brochure (PDF, 386 KB) for capability details 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

MORE CAPABILITIES

ACCESS, REVIEW, AND EVALUATE RESULTS

Perform ad hoc queries, and create a variety of charts based on the data. The system has multiple reports available off the shelf and the ability to configure your own reports 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. Advanced SQC and control charting are powered by Northwest Analytics (NWA) Automate routine lab data analysis and complex calculations Generate worksheets, result calculations, and specification comparisons

MANAGE MANUFACTURING MATERIALS AND EQUIPMENT

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 Manage equipment lists, scheduled maintenance events, calibrations, and QC with the equipment management module Manage all manufacturing laboratory materials and consumables, including the suppliers that provide raw materials for your lab

STREAMLINE AND AUTOMATE DAY-TO-DAY LAB LOGISTICS

Assign work to analysts and equipment based on availability and workload Interface to several systems for data sharing, including third-party systems SAP, Empower, Chromeleon, and other internal enterprise systems (EDMS/DS, MES, etc.) Integrate instruments without the need for complex programming. Parse serial data from an instrument, or from files containing instrument results, directly into fields in the manufacturing LIMS View key performance indicators, including bottlenecks, sample turnaround times, and out-of-specifications samples to make resource decisions Configure how often to archive data based on internal retention policies and schedules Manage customer information, and set up projects for laboratory testing, including test pricing, invoicing, and schedules for sampling and testing