Electronic Notebook Brochure

STARLIMS Electronic Notebook is Designed to Ease the Regulatory Burden Placed on Laboratories

An Electronic Notebook for Regulated Laboratories

Regulated industries are challenged to comply with ever-increasing regulatory needs, while simultaneously improving operational efficiency. STARLIMS has responded to these needs by developing an electronic notebook that helps harmonize regulatory compliance associated with test execution across the enterprise.

Electronic Laboratory Notebook

The STARLIMS Electronic Laboratory Notebook was designed for use in highly regulated environments, including QA/QC labs operating under GxP, ISO 17025 and FDA regulations. It is a powerful tool that ensures that all test preparation and execution steps defined in the Standard Operating Procedures are followed, and that all operational information and data required to meet regulatory requirements is appropriately recorded.

STARLIMS Electronic Notebook Enables Labs to:

  • Record data in electronic format straight from the source
  • Eliminate unreliable paper-based notebooks
  • Ensure that SOPs are strictly followed
  • Maintain a full record of laboratory processes

STARLIMS ELN: Full Traceability and SOP Adherence

STARLIMS Electronic Notebook maps each of the steps defined in a Standard Operating Procedure to an electronic worksheet and ensures that all the required information is recorded and validated at each step. This ensures that any given analytical procedure is carried out in strict compliance with the prescribed method; that each step in the procedure is electronically recorded; and that all the required supporting information (e.g., the materials, personnel, instruments and calculations employed in the process) is recorded in a manner that fully meets regulatory guidelines.

Converged Informatics Enhances Compliance

STARLIMS Electronic Notebook is integrated with the company’s Scientific Document Management System (SDMS) as part of the STARLIMS unified informatics platform. The STARLIMS SDMS can manage the creation, review and approval of SOPs. Once approved, an SOP is used as the template for the Electronic Notebook definition of the analytical method. Approval of an SOP can also trigger a certification request of the updated method for the relevant analysts. As a result, SOP management can be done through a single source – from creation to approval and adoption. Laboratories can effectively ensure that the correct SOP is always used, even in a multi-site and global testing organization. The STARLIMS unified platform is based on an open architecture that allows it to expose its functionality as web services and also to consume Web service functionality and data from third party systems. For example the ELN can retrieve SOPs from a third-party document management system.

Automatic data capture from analytical instruments supporting:

  • No extensive programming skills required
  • Allows for easy conversion of existing Excel spreadsheets to STARLIMS ELN methods
  • Use of Excel formulas can eliminate the need to learn new syntax
  • Easy to maintain and update

Part of a Comprehensive Platform for Laboratory Informatics

STARLIMS Electronic Notebook is part of the company’s unified laboratory informatics platform, which includes STARLIMS’s award-winning LIMS and SDMS. The STARLIMS platform enables organizations to centrally manage all the data and information created and used in the lab—using a single scalable platform that is entirely web-based. As a result, all users see the same data and information at the same time, and any authorized user can have access via a standard web browser.

In addition, the integrated STARLIMS solution minimizes maintenance, training and support requirements, since there is no need to maintain multiple computing platforms, applications or costly interfaces between the various systems. Based on standard .NET technology and utilizing Web Services, STARLIMS can significantly simplify integration to third-party systems such as Enterprise Resource and Planning (ERP) software.

STARLIMS Electronic Notebook Features and Benefits:

  • Replaces difficult to manage paper-based lab notebooks
  • Improves data integrity and reduces transcription errors
  • Makes data readily available across the enterprise
  • Promotes regulatory compliance
  • Ensures that SOPs are enforced
  • Guides analysts, step-by-step throughout the testing process
  • Automatic calculation of derived results
  • Automatic data capture from analytical instruments both complex and simple (i.e. serial and RS232 interfaces)
  • Supports Electronic Signatures
  • Integration with enterprise IT infrastructures
  • Entirely Web-based, runs on Internet Explorer
  • Compatible with standard security techniques
  • Scalable performance with high- availability
  • Wizards for simple and quick implementation of workflows
  • Part of STARLIMS unified platform
  • Streamlined implementation
  • No need to create and support multiple costly interfaces
  • Users only need to learn one application and user interface
  • Seamless upgrades for components of the unified platform
  • A single solution for the entire enterprise

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