STARLIMS Electronic Notebook:

Ensuring Regulatory CompliancE

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.
STARLIMS Electronic 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

Converged Informatics Enhances Compliance

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.

STARLIMS Electronic Notebook is integrated with the

companys 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:
Bi-directional interfaces with the Waters Empower CDS
Instrument files parsed and managed by SDMS
Serial RS232 devices such as balances pH meters etc.

Multiple wizards simplify method-building

3. Sequence is built

No extensive programming skills required

2. Prep data is
captured directly from
RS232 balance, etc.

1. SOP section
detailing sequence
list is highlighted

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

The STARLIMS Unified IT Platform

Empower

LAC/e32

RS-232
Instrument

LIMS

SDMS Grabber

ELN

SDMS

Office

Network Load Balancing

SharePoint

Database Cluster

Part of a Comprehensive Platform

for Laboratory Informatics

STARLIMS Electronic Notebook

Features and Benefits:

Integration with enterprise IT

infrastructures

STARLIMS Electronic Notebook is part

of the companys unified laboratory
informatics platform, which includes
STARLIMSs award-winning LIMS and
SDMS. The STARLIMS platform enables
organizations to centrally manage
all the data and information created
and used in the labusing 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.

Replaces difficult to manage

paper-based lab notebooks

Entirely Web-based, runs on Internet

Explorer

Improves data integrity and reduces

transcription errors

Compatible with standard security

techniques

Makes data readily available across

the enterprise

Scalable performance with highavailability

Promotes regulatory compliance

Wizards for simple and quick

implementation of workflows

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 Corporation
4000 Hollywood Blvd. #515S
Hollywood, FL 33021-6755 USA
Tel: +1 954 964 8663
Fax: +1 954 964 8113

Ensures that SOPs are enforced

Guides analysts, step-by-step
throughout the testing process

Part of STARLIMS unified platform

Streamlined implementation

Automatic calculation of derived

results

No need to create and support

multiple costly interfaces

Users only need to learn one

application and user interface

Automatic data capture from

analytical instruments both
complex and simple (i.e. serial
and RS232 interfaces)

Supports Electronic Signatures

Regional Centers
North America
Tel: +1 954 964 8663
Latin America
Tel: +1 954 964 8663

Seamless upgrades for

components of the unified
platform
A single solution for the entire
enterprise

Europe
Tel: +44 1204 546700
Asia Pacific
Tel: +852 2793 0699

www.starlims.com

Copyright 2009 STARLIMS Corporation. All brand names and product names used here are trademarks, registered trademarks or trade names of their respective holders. STARLIMS is a registered trade mark of STARLIMS Corporation.