Introduction

Interoperability

Web Architecture

End-to-End

Workflow

GLP

Future-Proofing

Delivery

SDMS

ELN

Partners

LIMS Training

STARLIMS Electronic Notebook

Harmonizing Processes Across the Organization

STARLIMS Electronic Notebook is a powerful tool to organize and manage information from standardized procedures, making it ideal for highly regulated environments such as laboratories working under GxP. STARLIMS Electronic Notebook has been specifically designed to tightly control the sequence of tasks, ensuring that Standard Operating Procedures are followed.

Electronic Notebook Boosts Data Integrity and Availability and Enables   Regulatory Compliance

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 activities across the enterprise.

STARLIMS Electronic Notebook was designed for use within QA/QC and other routine laboratories where Standard Operating Procedures must be followed. It is a powerful tool to ensure that all steps within laboratory processes are defined and followed, and that the required information is appropriately recorded. STARLIMS Electronic Notebook is used to monitor and control a wide range of laboratory processes: reagent lot preparation and expiration, instrument calibration, analyst qualifications, testing procedures, and more.

STARLIMS Electronic Notebook eliminates the need to maintain cumbersome and inefficient paper notebooks, enabling labs to record all required data in electronic format from the first moment it is created. Lost data and transcription errors are minimized; data storage and retrieval are streamlined; information is disseminated as soon as it is created; and regulatory information can be easily and efficiently retrieved. In short, STARLIMS Electronic Notebook ensures data integrity, accelerates its dissemination throughout the organization and eases the regulatory burden.

Compliance with Standard Operating Procedures (SOPs)

STARLIMS Electronic Notebook maps each of the steps defined in a SOP 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

An important advantage of STARLIMS Electronic Notebook is that it is part of the company’s unified platform for laboratory informatics. There can sometimes be a blurring of boundaries between Laboratory Information Management Systems (LIMS) and QA/QC-based ELNs (sometimes referred to as a Lab Execution Systems or Method Execution Systems). Each has distinct functionality designed to meet particular needs of the laboratory organization; yet they also generate and use similar types of information, which must be shared across the lab including information about: laboratory materials and inventory, user information (including authority levels), the tests or analytical procedures used within the laboratory, the SOPs themselves, etc.

The STARLIMS unified platform includes the Electronic Notebook, LIMS and SDMS (Scientific Data Management System). By deploying this platform, organizations can integrate a wide range of information from multiple sources into a single web-based platform. Data and information are visible and accessible to any authorized user—over the Internet via a standard web browser. Based on standard technology (.NET) and enterprise integration standards such as Web Services, STARLIMS significantly simplifies integration to third party systems such as Enterprise Resource and Planning (ERP) software.

In addition, deploying an integrated STARLIMS solution eliminates the need to maintain multiple computing platforms, applications or costly interfaces between the Electronic Notebook, LIMS and SDMS. Common data and information is defined and maintained in a single system and in a single place, alleviating the maintenance and support burden. Moreover, users need to learn only one user interface and a single system.

While STARLIMS Electronic Notebook can work as a standalone system, integrating it with LIMS and SDMS provides the opportunity to unify into a single solution all the information used or generated within the laboratory environment (including structured, semi-structured and unstructured data). In a sample scenario, for example, the STARLIMS SDMS manages the creation, review and approval of SOPs. When a SOP is approved, it is automatically integrated into the Electronic Notebook, triggering a request for certification in the updated method for the analysts who will be responsible for the specified tests. As a result of these automatic triggers, the entire management of SOPs can be managed from a single source—from creation to approval and adoption. Laboratories can conveniently ensure that the correct SOP is always used, even in multi-site and global testing organization.

“Isolated laboratory technologies are progressing toward a vision of 'converged informatics' eliminating the traditional architectural distinctions between LIMS, ELN, and SDMS,” said Michael H Elliott, CEO of informatics market research firm Atrium Research. “Users are increasingly demanding a holistic approach to workflow automation to minimize the challenges associated with custom integration of silo data repositories. With the addition of their ELN component, STARLIMS is the first major LIMS provider to deliver a systemic solution.”

Many organizations are running separate ELNs for R&D and for QA, as well as a LIMS for structured instrument data.