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Overview

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The pressure to increase compliance and efficiency within the Pharmaceutical market is at an all time high. With highly complex laboratory processes already in place, the Pharmaceutical and Biotechnology industries are faced with serious challenges.

Mergers and acquisitions have left companies with disparate systems.  Increased regulatory scrutiny and cost-cutting measures have both increased requirements and decreased resources.  Having a comprehensive laboratory informatics platform that addresses these issues is no longer an option, but an obvious necessity.

You need all of your laboratory informatics information easily accessible to both prove compliance and to measure efficiency.  STARLIMS ensures that the information you need is available when and how you need it. With streamlined processes and improved automation, STARLIMS offers a unified laboratory informatics platform that contains all core laboratory informatics applications in a single system.

You can increase your efficiency rapidly with STARLIMS because it is comprehensive, easy-to-use and intuitive.  This allows lab personnel to quickly become efficient in doing their job in a short period of time.  

STARLIMS allows your scientists to focus on their science, rather than on data entry.

STARLIMS can help you increase your compliance and efficiency while decreasing costs and turn-around times by:
  •     Streamlining audit preparation
  •     Reducing data entry
  •     Consolidating information systems
  •     Automating the right tasks

Efficiency

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Manufacturing QC

Supporting all aspects of the manufacturing process, STARLIMS optimizes the productivity of critical human resources, enhances data quality, and ensures compliance by allowing you to consolidate all of your QC manufacturing information systems into a single system.  This includes raw materials through product QC and stability testing.

Automate manual processes

Manual processes are costly, especially when they involve highly educated individuals performing business-critical data entry work. STARLIMS allows your personnel to focus on science by automating time-consuming manual processes with the STARLIMS Scientific Data Management System (SDMS).

Rapid instrument integration

Unlike most LIMS, the STARLIMS solution allows for rapid integration with instruments without the need for programming. By removing the need for programmers, STARLIMS allows almost all instruments to be interfaced in a very short amount of time.

Consolidate your information systems

STARLIMS offers a unified platform that contains all core laboratory informatics applications in a single system. No more switching between systems. Intuitive and easy to use, you’ll save time with STARLIMS’ centralized, unified and integrated platform and eliminate the need for multiple applications.

Cost Reduction

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Automation decreases your costs

With the STARLIMS unified platform, routine data analysis and calculations are automated, allowing you to review trends and make informed decisions, rather than continuously repeating the same task over and over again. By eliminating the need for time-consuming manual data-entry, personnel can focus on their core competencies, save valuable and expensive time while mitigating the risk of costly human errors.

Get to market faster

Reduce the amount of time your QA Managers and Qualified Persons need to spend reviewing and releasing QC information by eliminating unnecessary work. STARLIMS is built around a release by exception concept, which allows all “normal” testing to release automatically, with the system letting you know when something is out of the ordinary and needs additional review.

Streamline the auditing process

STARLIMS streamlines the auditing process by centralizing all of your labs operational information. This in turn substantially reduces the cost involved in preparing for an audit... With STARLIMS, QA personnel can access an entire sample history from a single screen, review the training history of each individual, display full audit trails and extract e-signature information and much more all with a few short clicks.

Compliance

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Pharmaceutical laboratories are looking for ways to reduce manual tracking within their quality programs, and for that they need truly comprehensive laboratory informatics solutions. The STARLIMS system tracks all aspects of laboratory informatics, from the lowest level test information through analyst certifications.

Support your laboratory’s compliance related to 21 CFR Part 11, ISO 17025 and GxP and others with STARLIMS.  The comprehensive Audit and Traceability modules functions help ensure that customers are able to show compliance when using the STARLIMS system, while at the same time decreasing the effort to do so.

Increase your compliance by implementing method execution

With STARLIMS ELN, analysts are always able to perform their assays with the proper Standard Operating Procedures (SOP) or Work Instructions. The STARLIMS Electronic Laboratory Notebook (ELN), allows personnel to view the most recent SOP as they perform an assay.  Furthermore, as an analyst completes any given workflow step, the system displays the next appropriate section of the SOP.  With STARLIMS ELN, you can rest assured that your analysts are not only executing each method properly, but also can demonstrate that they have access to the approved version at the time of execution.

Features

 Product QC Testing

  • All aspects of Product QC testing are covered by the STARLIMS system: Lot Genealogy; Multi-Level and Multi-Region specifications and COA’s; Workflow driven notifications and reports; Out of the box interface for SAP; Multi-Level review and release; Linked sampling and test plans.

Raw Materials

  • Manage your incoming materials effectively with the STARLIMS Raw Materials module.  With features like: Skip Lot testing (reduced testing); Dynamic data; out of the box interfaces for SAP.

Stability Studies

  • Manage your protocols, sample inventory, and each study all from within STARLIMS.  

Audit Trail & Electronic Signature

  • STARLIMS features a comprehensive audit trail system which supports electronic signatures.  This allows your organization to properly comply with the FDA 21 CFR Part 11 and the EU Annex 11 guidelines. By having all of the audit information available centrally, it is possible to greatly reduce the time for audit prep.

Sample and Test Workflow

  • STARLIMS supports dynamic sample and test workflows; a fully integrated investigations module; instrument interfacing; worksheet/list generation; result calculations; result specifications comparisons.

Sample Storage & Sample Location Management

  • STARLIMS includes comprehensive features for the management and storage of samples and storage locations.  Store your samples in hierarchical storage containers.  View the contents of each level of the storage hierarchy.

Environmental Monitoring

  • Make sure that all of your scheduled samples are properly collected and tested with the STARLIMS Environmental Monitoring module.  Efficiently manage sample points using visual floor plans.

Statistical Quality Control (SQC) and Control Charts

  • STARLIMS offers SQC and Control Charting powered by NWA.  This allows the creation of control charts, the configuration of the rules to track for the chart, and the ability to view the charts throughout the sample and product lifecycle.  Rule violations can be automatically detected which can drive further actions on samples and tests.

Dashboards, Data Visualization, and Reporting

  • Key performance indicators are available via dashboards with gauges to allow managers and analysts to effectively manage their time and resources.   Users can perform ad-hoc queries, and then create a variety of charts based upon the data.  Out of the box the system has hundreds of reports available.  Customers are able to create their own reports to further extend the reporting capabilities.

Inventory Management

  • STARLIMS supports management of all laboratory consumables with features for: MSDS Handling; Testing of received or created materials; Hierarchical storage of materials; Full chain of custody on each inventory item; Purchase order creation; Customer supply and invoicing of consumables and sample collection materials.

Equipment Calibration and Maintenance

  • STARLIMS features a full Equipment management module with features for: Equipment list; Scheduled maintenance events; Calibrations; QC Management.

Analyst Certifications & Training

  • STARLIMS allows the tracking and management of Analyst training for tests and methods including: Training per method and test; Scheduled courses; re-certification.

 Resource Planning and Scheduling

  • The STARLIMS QM system also a resource planning module which allows for advanced work assignment.  Save time by assigning work to your analysts and equipment based upon availability, and their current workload.

Supplier Management

  • Manage the organizations that provide Raw Materials and Laboratory consumables.

Client Management and Client Project Management

  • Manage your customer information, and setup projects for laboratory testing which include test pricing, invoicing, and schedules for sampling and testing.

Data Archiving

  • STARLIMS allows for archiving of data from the system for the purpose of maintaining system performance and to ensure that backup windows can be maintained over time.  This allows configuration of how often to archive data, and the rules for what data should be archived.  STARLIMS allows viewing and reporting of archived data.

System Interfacing

  • STARLIMS has certified interfaces to SAP and EMPOWER.  STARLIMS also supports several standards for data sharing including OPC and HL7. Additionally STARLIMS can interface with a wide variety of systems via all the following technologies: SOAP and REST-based web services; Application Programming Interfaces; Direct Database connections; and File-based interfaces.  STARLIMS has been successfully integrated with a wide variety of systems including, but not limited to: Equipment Calibration and Metrology Systems; Enterprise Document Management Systems; Training systems; Quality Event and Management systems; Regulatory compliance and change management systems; Process Historians; Statistical analysis systems;  Enterprise Resource Planning (ERP) Systems; and Manufacturing Execution Systems (MES).

Sample and Test Outsourcing

  • STARLIMS allows for the setup of third party laboratories and includes an entire lifecycle to allow the shipment of samples to third party laboratories for testing. 

 Electronic Lab Notebook (ELN)

  • Increases efficiency and compliance by allowing all structured and unstructured data collected as part of a method to be captured and retained.  Easy to use MS Excel like interface leads to a rapid learning curve and adoption rate.

Scientific Data Management System (SDMS)

  • Document management
  • Instrument data repository
  • Instrument Integration and advanced file parsing and extraction