General Manufacturing Lims Spec Document

ABBOTT INFORMATICS
STARLIMS
GENERAL MANUFACTURING
AND CONSUMER PRODUCTS
MANUFACTURING INDUSTRIES
LIMS SPECIFICATION DOCUMENT
VERSION 2.0 | | SEPTEMBER 18, 2017

INTRODUCTION
The purpose of this document is to list
the main functionality and features
available in STARLIMS solution
for the General and Consumer Products
Manufacturing Industries.
DEVELOPMENT
FORMULATION DEVELOPMENT
FEATURE / FUNCTIONALITY DESCRIPTION
Formulations and Recipes Create recipes and development batches associated with recipes, and test them
through standard STARLIMS workflows.
MANUFACTURING
Product Life Cycle - Lab Manage your typical lab processes encountered in manufacturing plants
Processes through pre-defined processes and functionality:
• Raw material release - Testing and validation of purchased raw materials
that are used in the manufacturing of a certain product.
• Continuous process monitoring - Sampling of a continuous scheduled
process at different sampling points and the testing and validation of
samples.
• Batch (Lot) and release testing - Testing and validation of samples
obtained from different stages in the process of manufacturing a product.
GENERAL MANUFACTURING AND CONSUMER PRODUCTS MANUFACTURING INDUSTRIES LIMS SPECIFICATION DOCUMENT
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MANUFACTURING
Product Life Cycle - Lab Manage typical manufacturing workflows with pre-defined steps or define
Workflows which of the pre-defined steps apply to your operations
• Plan - A batch, which is a group of samples and associated tests belonging
to a continuous process, or a Raw Material, is created and assigned a
Planned status. The batch may be created manually or electronically
from a 3rd party system such as Manufacturing Execution System (MES)
or Enterprise Resource Planning (ERP). Planned work is reflected in the
dashboard and will allow lab management to prepare for the anticipated
work load.
• Start - The batch is assigned a Start status to indicate that it is now being
manufactured. This triggers alerts, typically in the form of a label printed
in the production floor. This reminds personnel responsible for sampling
to collect the sample from the appropriate sampling points.
• Receive in Central Receiving (CR) - Samples may be received in a central
receiving unit that can aliquot, sort, and deliver the samples to different
labs and service groups.
• Receive In Lab - Collected samples are received in the lab, the labels are
scanned and an actual receive date and time are recorded.
• Testing and Recording Results - Testing in itself can be a whole workflow
of steps. Upon completion of testing, results are recorded. The system
performs required calculations and compares the entered results to pre-
set limits. An out-of-specification result may require the sample to be
sent for retesting or forwarded for sample disposition.
• Releasing Tests - Tests are released following results entry.
• Upon completion of each of the above steps, reporting and messaging
tasks are triggered, such as notification of an Enterprise Resource
Planning (ERP) system regarding a batch release. Some of the steps are
optional and can be configured using the static tables configuration tools.
Product and Sample Life Product and Sample Life Cycle (Includes Login, Receiving, Results entry,
Cycle Management Review and Approval).
Batch Inspections Perform acceptance sampling using standards defined by the American National
Standards Institute. Define inspection levels and acceptance criteria in ANSI
Tables.
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MANUFACTURING
Sample Group Template Sample Group Templates are structures that provide a way of grouping samples
to handle manufacturing requirements determined by plant/site or by stage in a
manufacturing process.
The grouping of multiple samples in a template is done according to a common

characteristics.
Sample Group template allows you to define material, testing and workflow
information to accommodate different manufacturing processes.
Equipment Management Manage equipment lists and components list, manage and track scheduled
and/or ad-hoc maintenance events such as repairs, preventative maintenance,
calibrations, and QC’s.
Set up standards used in the calibration of equipment, calibration curves, and

templates containing standards. Identify instrument that is used by a laboratory
to perform analyses or prepare samples for analysis.
Material Management Define the materials used in your facility and maintain comprehensive
information related to the material (i.e. safety instructions, chemical/physical
properties, vendor details, recipes, and component concentrations and container
information). Group together materials with similar characteristics using
Material type functionality.
Inventory Management Manage laboratory materials and consumables. Manage the consumption,
restocking, relocation and disposal of materials at your facility.
Storage Location Manager Manage the storage of samples, storage locations and sub locations, store your
samples in hierarchical storage containers and view the contents of each level of
the storage hierarchy, Storage locations are in rooms in buildings at a site. You
can configure this information to track and manage the movement and storage
of containers at a physical site.
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MANUFACTURING
Chain of Custody Display any inventory transactions for the sample (view history of how a sample
has been handled).
Stability Management Manage protocols, sample inventory, stability studies, pulling schedules,
conditions and locations, all within the system. Stability studies may be run
during product development, but are also run on production batches. Simulate
extended periods in a shorter time span with accelerated stability testing.
Customer and Project Manage your customer information, and set up projects for laboratory testing,
Management including test pricing, invoicing and schedules for sampling and testing.
Client Invoicing and Billing Bill clients for samples tested, create invoices that reflect the price list and other
payment terms that your facility has set for the clients. Bill clients for the tests
performed according to prices set for the tests and the materials used. Issue
invoices after samples are logged for testing or materials are shipped. Change
the price of an individual test, a package of tests or a material in the invoice.
Analyst Certifications Track and manage analyst training and certifications for tests and methods,
scheduled courses and re-certification.
Investigations Start an investigation to re-evaluate a questionable result or when a manager

suspects a problem. Open, view, collect the investigation details, order a re-test,
confirmatory test or re-sampling for samples under investigation. Assign the
investigation steps to a user or role to perform the step.
Batch/Lot Genealogy When batches are made using materials from other batches, such as batches of
raw or formulated materials, you can trace back to these other batches to view
pertinent information. Lot genealogy allow you to view the different components
(materials) that are used in the batch.
The lot genealogy tree provides a view of a batch and its material code, material
name, its associated samples and their test results. An OOS image displays when
at least one sample in the highlighted batch in the Lot Genealogy tree has an OOS
result recorded.
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MANUFACTURING
Statistical Controls, Control Create control charts, configure rules to track within the chart, and view the
Charts and Trending charts throughout the sample and product lifecycle. Rule violations can be
automatically detected, which can drive further actions on samples and tests.
Advanced SQC and control charting are powered by Northwest Analytics
(NWA). Display trends and observe patterns in sample results over time in a
graphical format.
Reporting and Querying STARLIMS provides several ways to monitor and track data in your facility by
generating reports and queries. Use database re-usable query templates and
generate Crystal reports file from the query results. STARLIMS offers a standard
set of pre-defined reports available for areas such as general results and folder
status. Create a report specific to your needs by further filtering information
using a query.
Report Qualifiers Result Qualifiers are used to describe results in printed reports. They can
provide more details. The report may display the qualifier value along with the
corresponding text.
Formulations and Recipes Create recipes and development batches associated with recipes, and test them
through standard STARLIMS workflows.
Contract Labs Performs test and analyses for customers as opposed to an internal lab that does
testing for a company. Client Projects application contains data about specific
projects associated with clients. The information includes terms, contacts,
project samples, results, metadata, project orders and invoice information.
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MANUFACTURING
Customer and Project Manage your customer information, and set up projects for laboratory testing,
Management including test pricing, invoicing and schedules for sampling and testing.
Samples and Tests Outsource tasks with third-party (internal or external) laboratories and
Outsourcing document the samples for testing at an outsource lab, whether it is internal or
external.
Manufacturing Life Cycle Effectively manage your batches, from creation to delivery of a final Certificate of
Analysis (COA). Dynamically control the tests performed on batch samples, based
on the frequency of testing and prior test results.
Label and Barcode Utility Generate barcode labels and read bar code labels throughout certain steps
within the applications.
Environmental Monitoring Monitor the production environment in which batches are created. Ensure that
all of your scheduled environmental samples are properly collected and tested
with the environmental monitoring module. Efficiently manage sample points
using visual floor plans. Use this application to verify that those components in a
production environment are clean and sterile.
Environmental Monitoring Pre-defined Environmental Monitoring Lifecycle workflows

Life Cycle • Environmental Monitoring Login - Use to log in and schedule a batch
of sample points.
• EM Samples Pending Collection - Indicate collection of the samples is
completed for sampling requirements using this application.
• Receive EM Samples - Receive the containers of samples gathered in a
sample point.
• Environmental Results Entry - Locate environmental samples pending
testing, indicate their movement to the location for testing, and enter the
test results for each sample.
• Release EM Batches - Use to approve results. Optionally, a run release
step can precede this step.
Samples Zones Define Sample Zones and provide the sampling points on which environmental
monitoring or other type of sampling has to be performed, such as water
systems, clothing, and surfaces or as applicable.
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MANUFACTURING
Real World Application Real World application provide a graphical view of a process. The graphical
depiction is overlaid with transparent clickable labels, each representing a
sampling point.
Microbiology Life Cycle Define a more complex, dynamic test workflow (i.e. sequence of steps that change
at run-time based on results). Microbial tests work best for workflow steps that
change depending on results and that are very complex.
Plates Life Cycle Samples can be added to a well plate or tube rack, tested, and results entered
according to a workflow of steps. Create a plate map template, a workflow of
steps, and a test to associate these elements with equipment to process the plate.
After all elements are in place, samples can be logged, then the plate workflow
becomes available for processing using the Plate Lifecycle Tasks application.
QC Management The QC Management module allows you to log and track quality control
samples in your laboratory. You can run tests to verify quality control of your
laboratory, instruments or methods.
Electronic Signatures, Track aspects of your lab data, from the lowest level result and test information
Audit Trail and Traceability to analyst certifications. Access an entire sample history, review the training
history of each individual, display full audit trails, extract e-signature
information, and others.
Electronic Signatures STARLIMS QM supports electronic signatures. Use electronic signatures to

configure approvals and rejections. Supervisors and others can then approve actions
as the samples move through the laboratory life cycle.
User Access, User Assign system access (username and password) to users so they see only the
Management and Roles interfaces to tasks they may perform. You also assign each user a role, site,
and service group (also called team) access. The role determines what console
branches are displayed for that user. Site and service group access determines
which site the user logs into and which samples appear for the user to process.
If a user is allowed access to more than one site, the user is prompted to select a
site when entering the system. During the creation of a user in the system, you
can assign a unique username and password. At this time, you can also assign a
common signature name which is typically the common name of the user along
with any professional prefixes or suffixes.
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MANUFACTURING
SmartCard Login STARLIMS supports logging on using a SmartCard. After entering their
credentials for the SmartCard, users can start STARLIMS without having to re-
enter log on information. SmartCard SSO can also be used for other STARLIMS
events that require an electronic signature.
Work Assignment Allow laboratories to manage both human and instrument resources.
Resource Planning and Save time by assigning work to your analysts and equipment based on
Scheduling availability and their current workload. Managing the laboratory workload is
important to reduce turnaround times, improve performance, and assess the
use of people and equipment to balance work between the available resources.
To make the most effective use of laboratory resources, the RPS module is
a helpful tool in prioritizing deadlines while using available equipment and
analysts.
Dashboard Gauges The STARLIMS Dashboard can visually inform users about laboratory
(Monitoring Performance) performance or individual analyst workload by displaying gauges. There are two
types of gauges you can add to the dashboard, each with their own set of reports
intended for users with management or analyst roles.
• Gauges for Management
• User Gauges
The Gauges for Management section of the Dashboard display defined Key
Performance Indicators (KPIs). It shows graphically the status of a specific
operations/tasks in the LIMS and lists standard reports about samples in various
stages of processing. The dashboard is configured for users based on role.
The User Gauges section of the dashboard graphically shows the status of
specific operations or tasks in the LIMS and list standard reports about samples
in various stages of processing.
Metadata Templates Metadata is data about data. Metadata provides an area to expand information
based on fields defined in a template. Templates are available to be included
in an application’s Metadata tab according to the Usage selected.
You can configure templates of fields and captions and lay these elements
out on a page for inclusion in Metadata tabs. Metadata tabs are used by
applications that are expected to require the additional fields.
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MANUFACTURING
Workflow Manager STARLIMS allows you to set up a workflow of multiple steps that can be
executed by different people. Frequently, different users with different
responsibilities handle the different steps of workflow.
Most STARLIMS applications only recognize one workflow, that is, there is
one workflow with the relevant Application Reference and Code keywords.
Exceptions are Stability Study Protocols and Stability Study Management which
provide the ability to select alternative workflows.
Authorization Models The Authorization Models application can be used to obtain multiple
approval signatures simultaneously, or as a notification mechanism through
acknowledgment. Authorization roles are different from STARLIMS roles. Users
are assigned either a Primary role or Backup role in the authorization model.
The primary user will have to fulfill an action, or if the primary user is not
available a backup user can be assigned to complete the action
Method Manager List your methods, such as Standard Operating Procedures (SOP) or
American Society for Testing and Materials (ASTM) methods. Select from
available methods when configuring a test.
Methods are associated with analytes within Test Manager and Sample Group
Templates, Test Plan Manager, or Stability Study Protocols.
Methods can be associated with electronic notebooks (ELN), which can be used
to display associated SOPs while an analyst is performing tests. Within an ELN,
the analyst can also be guided through a workflow of sequential steps including
constraints when required data is not entered.
Specifications Manager Specs are an important part of results entry. You can set limits (specifications)
outside of which the results are considered to be positive, abnormal, or out-
of range. You can configure multiple specifications for an analyte to allow for
different requirements.
The Specifications Manager displays all existing specifications in the LIMS

along with the tests and profiles to which they are associated. Specifications are
used to contain values for comparison with results to determine if the results
entered exceed limits.
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MANUFACTURING
Ad Hoc Multi-Spec The Ad-Hoc Multi-Spec Evaluation application allows you to evaluate sample
Evaluation test results against different sets of specifications.
The Multi Spec command allows you to compare your current results against
other specifications aside from the primary spec in your test plan or template.
Within this application, you can evaluate any set of sample results available in
the LIMS against any set of specifications defined in the system.
Test Manager Test Manager lists the tests that can be performed by your laboratory. The test
configuration includes analytes used, spec schema to be used on results entered
for each analyte, methods used in analysis, the equipment used for measuring
results and preparing samples for analysis, the specifications (limits) to which the
results are compared, reagents that are used when a test is performed, and other
test parameters.
Spec Schemas The Spec Schemas application is used to create spec schemas and schema groups.
Spec Schema can be used to apply calculations, validations, or otherwise define
results of tests. For example, use a spec schema to perform a calculation on several
measurements and then validate that the final result is within a specified range.
The schema can be used to define the information displayed or used for a test in the
Results Entry window such as:
• The characteristics of expected analytes: high and low values, list of
possible values, % recovery, and others.
• The set of fields that will be required to enter measured data or to display
calculated data for an analyte.
• The properties of each field displayed: field caption, width, etc.
• Calculation formula used to validate or calculate a result.
Units Management Define and categorize units of measurements into types, define its conversions.
Alert Management Alerts are used to send messages through the LIMS to other users. You can create
an alert, send the alert, and someone acknowledges the alert.
Email Manager The system can automatically send emails to alert users when events occur that
are of interest to them, such as the release of a COA report. If an email does not
go out as expected, it is queued in the Email Manager application.
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MANUFACTURING
Sites Sites module allows you to define the organizational structure of your laboratory
locations. After creating a site, you can define the teams (or Service Groups)
that operate at each location and assign members to them. Sites can also include
detailed structural information about plants, buildings and rooms which allows
you to define inventory storage locations or keep track of testing locations at a
more granular level.
Open Productivity Open connectivity (OPC) Server, provides standards to facilitate communication
Connectivity (OPC) Server of information such as results between systems such as STARLIMS and other
manufacturing applications
Data Archive Configure how often to archive data based on your retention policy, schedule
and improve system performance.
Importing Data Using CSV STARLIMS provides a way to set up your organization’s data in the system
by importing it through .csv files. STARLIMS provide a set of pre-configured
templates to upload master static data. In addition, imports are used for loading
LIMS tables using .csv files when the data is already configured on another
system and you want to import it into your LIMS.
Instrument Integrations Integrate your instruments without the need for complex programming.
(DCU)
Empower 3 CDS STARLIMS interacts via a bidirectional interface with the WATERS EMPOWER
Integration Chromatography Data System. This software works with High Pressure Liquid
Chromatography (HPLC) and Gas Chromatography (GC) equipment. STARLIMS
supports EMPOWER software up through EMPOWER 3. The interface allows
STARLIMS to send a list of samples together with QC samples to EMPOWER
creating a Sample Set Method in the EMPOWER project.
Once the data is collected in Empower CDS import relevant data back to LIMS via
mapping. You can use the electronic notebook to retrieve instrument results. ELN
can be used with systems such as EMPOWER (interfaces are bi-directional).
The STARLIMS -CDS integration, increase automation, minimize data entry

errors and eliminate redundant data entries.
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MANUFACTURING
Chromeleon 6.8 and STARLIMS interacts via a bidirectional interface with the Chromeleon
Chromeleon 7.2 CDS Chromatography Data System. This software works with High Pressure Liquid
Integration Chromatography (HPLC) and Gas Chromatography (GC) equipment. STARLIMS
supports Chromeleon Version 6.80 SR13 Build 3967 and Chromeleon 7.2.
The interface allows STARLIMS to send a list of samples and QC samples to
Chromeleon and then creating a sequence or adding the samples to an existing
sequence.
Once the data is collected in Chromeleon CDS import relevant data back to LIMS
via mapping. You can use the electronic notebook to retrieve instrument results.
ELN can be used with systems such as Chromeleon (interfaces are b-directional).
The STARLIMS -CDS integration, increase automation, minimize data entry errors
and eliminate redundant data entries
NWA Integration STARLIMS allows the interaction between the system and NWA Quality Analyst
third party software. The Trending and QC Charts interfaces differ depending on
whether you have NWA Quality Analyst enabled in your system or not.
Interface Connection The STARLIMS application can interact with external applications, such as
SAP, either using an ES Bundle via Web services or other technology depending
on the customer’s software infrastructure. The Interface Connections
application can be used to translate information between the LIMS and the
third party interfaces. To minimize development time and to allow reusability
of interfaces, a template named Template Interface is provided which formats
and packages information from the LIMS. You can add scripts to this base
template to allow the LIMS to receive a response from one or more third party
applications.
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MANUFACTURING
SAP Integration In the manufacturing world, quality inspections are performed against batch.
SAP’s module allows rudimentary result recording, but lacks sample life cycle,
instrument interfacing, and many other standard LIMS features.
SAP recognized this lack and offers different technologies to connect a LIMS to
their quality management module.
STARLIMS supports SAP interface to help companies who want to integrate
their LIMS into their enterprise system landscape.
STARLIMS supports 2 different technologies for SAP, both with different

prerequisites:
SAP Enterprise Services for Quality Management
• Commonly known as the “ES Bundles”, this uses web services and requires
SAP ECC 6.0 with enhancement packs 1 & 2.
SAP QM-IDI
• This “older” technology relies on COM/DCOM libraries to communicate
with SAP RFC (remote function calls). This interface requires SAP R/3 or +,
and is an integral part of SAP Quality Management module. This is typically
the preferred solution when prerequisites for the “ES Bundles” cannot be
met.
The SAP Mapping tab in STARLIMS defines the relations between STARLIMS
and an SAP interface components. This allow STARLIMS to work in
conjunction with SAP systems.
With the SAP and STARLIMS integration Lot information can be send from SAP
to STARLIMS which can trigger the creation of a batch, the Batch samples will
follow the regular life cycle as configured (Receive, result entry, review, approvals
or as applicable). Once results are entered in LIMS, results can be send back to
SAP. In addition, once the samples that pertain to the batch are disposition as well
as the batch, status of the samples and batch can be sent also to SAP.
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MANUFACTURING
Multiple Systems Interfacing STARLIMS support several standards for data sharing, including open connectivity
(OPC). Our LIMS also has interfaces to SAP, Empower and Chromeleon. Additionally,
our software can interface with a wide variety of enterprise systems via:
• Simple Object Access protocol (SOAP) and Representational State
Transfer (REST)-based web services
• Application Programming Interfaces
• Direct Database connections
• File-based interfaces
Our LIMS has integrated with a wide variety of systems, including, but not
limited to:
• Equipment calibration and metrology systems
• Enterprise Document Management Systems (EDMS)
• Training or Learning Management Systems (LMS)
• Quality event and management systems
• Regulatory compliance and change management systems
• Process historians
• Statistical analysis systems
• Enterprise Resource Planning (ERP) systems
• Manufacturing Execution Systems (MES)
REGULATORY COMPLIANCE
Support 21 CFR Part 11

The Title 21 Code of Federal Regulations (21 CFR Part 11) provides compliance
Compliance/
information regarding Electronic Records and Electronic Signatures. Basically,
Electronic Records/
certain guidelines are set forth to help insure security, integrity, and confidentially of
Electronic Signatures
electronic records and to insure that electronic signatures are as legally binding as
hand-written signatures.
STARLIMS has features to support 21 CFR Part 11 regulation compliance. Below are
some of the features.
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Authentication STARLIMS requires a unique username and password for authentication into the
system. Passwords are encrypted. In addition, STARLIMS offers the option of
LDAP server authentication.
Authority Checks The system uses authority checks such as user ID and password to ensure that only
authorized individual can use the system. In addition, when applying electronic
signature users have to enter their credentials.
Group Memberships and Access to the system is controlled by roles, sites and service groups. Roles are used
Access Privileges to manage security access and operation of the system and to grant or revoke the
user’s right to perform different actions. Security measures defined by role and
user information are used to control access to data and system functionality and to
track system login failures and successes. System allows for creation of unlimited
roles with assigned privileges, and the assignment of those roles to the users.
Site and service group access determines which site the user logs into and which
samples appear for the user to process.
Security and Password Policy STARLIMS allow you to set password policies as a global setting or based by roles;
among the available password policies are: grace login, password expiry date,
password complexity, failed password attempt lock out, inactive timeout/lockout
period, among others. Users can retrieve their password using the pin number and
security questions they set the first time they logged on.
Audit Trail and History STARLIMS generates time –stamped audit trails. The audit trail record the date
and time of the operator entries or actions. Audit trails can be collected for creation,
modification or deletion of records.
STARLIMS provides you the ability to track changes made to a given field. This
ability to track is critical for satisfying CFR Part 11, the Title 21 Code of Federal
Regulations.
STARLIMS allow you to view the login history. The History application is the
access point for this information. The History window displays event logs with
signatures and audit trail records. When you set auditing for a record, associated
tables, controls, and events are monitored. After you start auditing, you do not have
the option to stop auditing. The Audit Trail window includes a Search option.
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Login History/User History Login History - following a successful login procedure, a user will be notified of
the last successful login, last successful password change, last failed login attempt,
and the number of failed logins since the last successful login.
User History - The User History lists login failures and successes for the
highlighted user, the server to which the user connected, and at what time.
Electronic Signatures and STARLIMS provides you the capability to configure electronic signatures based
Audit Trail on workflow rules and triggers. Example you can configure sign off capabilities on
a certain actions during the laboratory life cycle. It is possible to add an electronic
signature to certain system events. Not all events are available to have an electronic
signature added.
With STARLIMS you can require E-Sig Comments, or require users to provide their
user name and password when electronically signing a record. Comments made by
users are added to the audit trail history.
In addition, you can configure an E-signature witness - which requires another
user that is a witness, to sign with his user name and password before an action
takes place.
Some workflows allow the automatic start of audit trail functions. Audit records
are linked to the individual that performed the action through the collection of the
user’s electronic ID or electronic signature.
During the creation of a user in the system, users are assigned a unique username
and password. At this time, the user can be assigned a common signature name
which is typically the common name of the user along with any professional
prefixes or suffixes.
Thus, the signature field can be readily used in reports or required authorization
fields where a more meaningful representation of the user’s name is needed. When
users sign-off on actions, the signature text is displayed in applications listing those
actions, such as traceability and audit trail.
Each signature record includes the username of the person who performed the task,
the date and time the task was performed, and comments. Electronic signatures are
linked to their respective electronic records.
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Security, Data Protection User ID s are unique and User passwords are encrypted. User can be required to
and Encryption reset their password at first logon. If the customer needs all data encrypted this
can be turned on at the RDBMS level.
Note: Full encryption of all data may result in performance degradation. Default
system accounts can be disabled as required.
Human Readable Records STARLIMS has the ability to accurately generate or produce electronics records
data in both human readable and electronic formats.
Enforcements of Sequence STARLIMS allows you to enforce the sequence of steps via configured workflows
of Steps and via the Electronic Laboratory Notebook (ELN).
Enforcements of sequence of steps through My Service Groups Runs

This results entry option is useful if you have several samples that require the
same tests, or when the tests have several replicates and you want to perform a
calculation of some sort (such as an average) using the replicates’ results.
You use a run (work sheet) to assign analysts to perform tests. Use the run window
to list a group of samples on which a type of test is to be performed. Assign each
run to an analyst who performs the test on the samples. In addition, you can
use runs to enforce sequences of steps to be performed. These steps can include
preparation, approval, run creation, results, validation, and retesting steps. As the
run moves through the steps according to the step code, corresponding buttons
appear. After entering data into fields and tables, you click on these buttons to
move the work sheet to the next step.
You can also use runs to specify the materials needed to perform tests, assign
equipment, and specify the due date for the test to be completed.
For the Microbiology life cycle you can configure that the sequence of steps
changes at run-time based on results.
Enforcements of sequence of steps through ELN

You can apply a workflow to the ELN Template, which mean that you can control
the order in which ELN sheets are completed when the ELN form is run.
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Microsoft Active The system can be integrated with Microsoft Active Directory such that users are
Directory Integration for able to log into the system using their current network credentials. LDAP is also
Authentication supported.
STARLIMS allows users to authenticate when logging in over connections with

an LDAP server. LDAP is Lightweight Directory Access Protocol, which allows
users to query and authenticate with a database over TCP/IP.
Protection of Electronic STARLIMS provide controls that ensure electronic records are protected
Records Controls and available during the data retention period. System access, data creation,
Throughout Retention modification and deletion is controlled via user id, password, service groups, roles
Period and its corresponding access privileges. Purging or deletion required to enforce
retention periods could managed using the archive module.
Archive STARLIMS provides an Archive module which allows you to archive and restore
data. With this module you can define: network locations for the archives, the type
of data that gets archived, and the age of the data to be archived.
SmartCards STARLIMS supports logging on using a SmartCard. After entering their credentials
for the SmartCard, users can start STARLIMS without having to re-enter log on
information. SmartCard SSO can also be used for other STARLIMS events that
require an electronic signature. SmartCards provide a portable security solution
for tasks such as identification, client authentication, data storage and application
processing. They can provide strong security authentication for large organizations
that single sign-on (SSO) to control access to their enterprise software.
Ability to Detect Invalid or STARLIMS provide the ability to detect invalid records (e.g. during data entry).
Altered Records You can configure STARLIMS to detect invalid record. You can define required
(mandatory) fields. The system can provide visual indicators (flag) for the data that
it is out of specification. Also the system can provide flags when data is entered that
is beyond allowed limits.
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Ability to Detect Invalid or The system will prevent you from committing the sample in the following cases:
Altered Records (Cont.) • If an invalid (unapproved or expired) specification is assigned to the
sample.
• A test with an invalid method is assigned to the sample.
• If the tests/analytes assigned to the sample do not match the tests/
analytes in the specification assigned to the sample. In this case you will
still be able to commit the sample, however, the system will notify you of
the mismatch.
In addition, record and application access privileges are controlled via roles and
service groups. Alter or modified records can be captured via audit trails.
Examples of Invalid records scenarios are:

• For Spec Schema groups: Attempting to populate Start Date and Expiry
Date fields with invalid input (such as YYYY/DD/MM rather than MM/
DD/YYYY) will display a blinking red icon on the top right
• For Location Types blinking red icon is displayed if you attempt to
update Size and Order fields with invalid input (such as ABC rather than
numeric values).
SUPPORTING ISO 17025
How STARLIMS Supports The STARLIMS product supports customers in operating their laboratories in
ISO 17025 a manner that is compliant with ISO 17025. Below is some of the ways how we
support those laboratories.
p22
Document Control In addition to a Laboratory Information Management System (LIMS) which

allows you to centralize your laboratory testing process data, our Integrated
Solution includes a Scientific Data Management System (SDMS). The Scientific
Data Management System extracts information from scientific documents
and instruments and places it into a structured, easy-to-access format. SDMS
has features, like document management, document routing, instrument data
repository, instrument integration, and advanced file parsing and extraction,
supporting you with document control.
Supplier Management STARLIMS QM Suppliers application contains detailed information about vendors
who provide commodities used by a facility. You can use this application to manage
information about suppliers (Supplier code, supplier name, phone, fax, web link).
It allows you to define supplier location and contact information. Also you can add
meta data fields to track supplier’s certifications.
Analyst Certifications With STARLIMS QM you can track and manage analyst training and certifications
and Training/ Training and for tests and methods, scheduled courses, and re-certification. The Organization-
Authorization of Personnel Resources module includes information on courses and analysts’ certifications.
Courses The STARLIMS Courses application provides tools to manage available courses,
their cost, content, and the test methods they cover. This information can be used
later to schedule training or set certifications within the other applications Course
Schedule and Analysts Certifications.
Course Schedule Some laboratories, especially in regulated industries, require that analysts
carrying out tests be certified (or validated) to perform the test methods used in
the lab. Using the Course Schedule application, training courses can be scheduled,
participants selected and invited, and certifications are granted.
Analysts Certifications In STARLIMS when you assign tests to samples, they are routed according to
the appropriate laboratory service group. If your facility requires that the tests be
performed in a certified lab or by a certified analyst, you can check on certifications
when assigning samples to labs and analysts.
Equipment/Instrument STARLIMS provides a full Equipment Management module to manage equipment

Calibration and Maintenance lists, scheduled maintenance calibrations and maintenance events, QC standards,
and automated alerts.
The Inventory Manager allows you to manage the consumption, restocking,

relocation and disposal of materials at your facility.
p23
Inventory and Materials You can manage all laboratory materials and consumables including:
Management • Material Safety Data Sheets (MSDS) and SDS handling
• Testing of received or created materials
• Hierarchical storage of materials
• Full chain of custody on each inventory item (reception, consumption,
restocking, relocation and disposal)
• Purchase order creation
• Customer supply and invoicing of consumables and sample collection
materials
• National Fire Protection Association (NFPA), Hazardous Material
Identification System (HMIS) and Global Harmonized System (GSH)
labels
Environmental Monitoring You can monitor the production environment in which batches are created.
Module Ensure that all of your environmental monitoring scheduled samples are properly
collected and tested. Efficiently manage sample points using visual floor plans with
STARLIMS.
Statistical Process Control With STARLIMS Statistical Quality Control (SQC), Control Charts and
Charts and Trending Trending you can create control charts, configure rules to track within the chart,
and view the charts throughout the sample and product lifecycle. Rule violations
can be automatically detected which can drive further actions on samples and
tests. With the trending tools graphically display trends and observe patterns in
sample results over time. Advanced SQC and Control Charting are powered by
Northwest Analyticals (NWA).
Reporting and Querying “The results of each test, calibration, or series of tests or calibrations carried out by
the laboratory shall be reported accurately, clearly, unambiguously and objectively,
and in accordance with any specific instructions in the test or calibration methods”
(ISO 17025). Calibration reports can be generated via STARLIMS.
STARLIMS provides several ways to monitor and track data to manage

performance in your facility:
• Dashboard Gauges (Monitoring Performance) - Monitor daily activities
to assess performance and workload in your facility.
• QBE Manager - Use to configure database query templates and generate
reports in the system. For example, you can get a report about how many
samples run through a specific instrument were rejected. An unusual
number of rejections may show the instrument needs more frequent
maintenance.
p24
Reporting and Querying • Trend Analysis with Control Charts - Track data over time to determine
(Cont.) potential problems in advance.
• QC Charts - For viewing and configuring equipment control charts.
• Labels Count - View reports of the amount of labels that have been
printed for containers in various applications.
Data Visualization and View key performance indicators via dashboards, get an indication of time
Reporting and resources utilization, bottlenecks, sample turn around, number of Out of
Specifications, drill down data and identify probable root causes. Perform ad-
hoc queries, and create a variety of charts based upon the data. The system has
hundreds of reports available out of the box and the capabilities to configure your
own reports. Generate certificate of analysis and many other reports.
Product Quality Control Some of the aspects of Product QC testing covered by the STARLIMS system.
Testing • 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
Sampling and Material Sample and Test Workflow

Testing STARLIMS supports sample and test workflow from start to finish, you can
configure triggers, sample points, re-sample and re-test workflows. Link to open
investigations through the integrated investigation module. Additionally, you may
generate worksheet/list, result calculations, and result specifications comparisons.
Sample Storage and Sample Location Management

Manage the storage of samples, sample storage locations and areas. Store your
samples in hierarchical storage containers and view the contents of each level of the
storage hierarchy.
Sample Schedules and Sample Points

Set up your sample schedules to automatically schedule sampling points and QC
samples based upon multiple criteria. Almost any type of sample schedule can be
created, including hourly, daily, and annual schedules. Easily view sample schedules
in a calendar format and visualize when samples will be logged.
Samples Draws-configure batch draw profiles and its associated tests and sampling
requirements.
p25
CROSS FUNCTIONAL
Advanced Analytics Accelerate your lab by transforming your data into actionable insights. From
powerful visualizations that more clearly illustrate key activities to predictive
analysis capabilities that help you anticipate critical events, Advanced Analytics
gives you the insight you need to manage your lab.
Electronic Laboratory STARLIMS Electronic Lab Notebook (ELN) provides centralized electronic
Notebook (ELN) replacement for paper lab notebooks and other homegrown solutions used to
record your lab data. Whether you are looking to capture interim result data in
tables, create calculations on the fly using standard Excel formulas, add pictures
and annotate, or include attachments, the Excel-like interface provides you with
a canvas to capture and store your data in a central repository. The ELN makes it
easy to search, easy to share and maintain compliance with your organization’s
record retention rules. The ELN also manages both structured and unstructured
data and provides method execution capabilities to ensure SOPs are followed, and
the method/SOP is visible while you are executing the steps to ensure compliance.
Using an electronic solution enables you to transform your lab into a paperless
operation and reduce paper management costs.
Scientific Data Management Scientific Data Management System for centralized management of documents,
System (SDMS) lifecycle management and automatic document routing and indexing; parsing
and recognition technology that transforms a variety of documents or files into
searchable structured information.
Mobile Applications Access your lab remotely and stay connected. Abbott Informatics mobile offering
gives you the ability to access some of the data of your lab on the go. The mobile
solution is optimized for a wide range of screens and devices. From out-of-the-
box apps to ones you can custom design to fit your lab’s needs.
p26
TECHNOLOGICAL ADVANTAGES
AND COMPATIBILITY
Multi-tier Technology STARLIMS technology platform is used by all of the market verticals and is the
functionality that presents the user with the user interface and data which is configured
in the business layer. By making the technology platform separate from the business
layer STARLIMS customers can take advantage of rapid changes in IT infrastructure
and gain access to novel tools like HTML5 and Mobile Application development
without disrupting their business layer. The STARLIMS technology platform can be
independently upgraded with little overall business and validation impact.
Web Based Fully web-based solution, for instant global deployment. Unlike the web-enabled
and partially web-based LIMS which still require some software downloads on
the client side, ours is an entirely web-based system. Validate it once, and you can
deploy it globally, to any authorized user with a standard web browser. Developed
as a purely web-based platform.
Integrated Solution STARLIMS is the only LIMS vendor to provide a completely integrated solution
incorporating LIMS, ELN and SDMS in a single application. This eliminates the
need for building and maintaining custom interfaces to third party tools. Our
Integrated Solution combines all of your lab data on a single platform—optimize
data management, accessibility, integrity, and provide the long-term value needed to
transform data into actionable, impactful insights.
Our Integrated Solution can include a combination of:
Laboratory Information Management System (LIMS)

Our LIMS solutions expertly handle complex processes, support regulatory
compliance, and promote collaboration within your lab and among labs around the
world.
Scientific Data Management System (SDMS)

Our SDMS extracts information from scientific documents and laboratory
instruments and places it into a structured, easy-to-access format.
Electronic Laboratory Notebook (ELN)

Our ELN eliminates paper-based notebooks, forms and log books to increase
efficiency, reduce error rates, and promote regulatory compliance by helping to
enforce method execution.
p27
TECHNOLOGICAL ADVANTAGES AND COMPATIBILITY
Integrated Solution (Cont.) Advanced Analytics

Use real-time data to make critical decisions quickly. By providing an easy way to
view and analyze all of your laboratory data through intuitive graphs and tables.
Mobile
Take your lab on the go. Use your smartphone or tablet to track inventory, manage
user access, view key performance indicators, and much more. By having full control
of the lab at your fingertips, you can increase productivity and efficiency even when
you are away or in the field.
Database Compatibility STARLIMS is compatible with SQL and Oracle databases. Our system database
conforms to Open Database Connectivity Standard (ODBC). STARLIMS Database
servers can be clustered to provide failover support.
For additional details contact Abbott Informatics.
Operating Systems STARLIMS can be installed on Windows based operating systems. STARLIMS
Compatibility Application servers can be scalable through the use of MS Windows Clustering and
Network load balancing services. For additional details contact Abbott Informatics.
Application Server STARLIMS application supports a virtualized environment.

Virtualization
STARLIMS application may be installed on VM thus reducing the number of
required physical servers and energy requirements. We support VMWare, Hyper-V
and Xen Center.
Multiple Environments STARLIMS integrated platform offers support for multiple environments such as
PC (using as the client the IE browser for the traditional STARLIMS XFD forms
and any browser for HTML5 compatible forms), smart phones and tablets (using
STARLIMS Mobile capability for iOS and Android mobile operating systems).
Total Cost of STARLIMS is the only LIMS vendor to provide a completely integrated solution
Ownership incorporating LIMS, ELN and SDMS in a single application. This eliminates the need
for building and maintaining custom interfaces with third party tools and maximizing
the total cost of ownership associated to maintaining third party integrations.
p28
informatics.abbott
ABBOTT INFORMATICS
Tel: +1 954 964 8663
4000 Hollywood Blvd, Suite 333 South,
Hollywood, FL 33021-6755 USA
UNITED KINGDOM JAPAN

Tel: +44 161 711 0340 Tel: +81 3 4555 1000
NETHERLANDS FRANCE
Tel: +31 72 511 8100 Tel: +33 1 61 37 02 00
AUSTRALIA LATIN AMERICAA

Tel: +61 3 9670 0678 Tel: +1 954 964 8663
GERMANY SPAIN
Tel: +49 2302 915 245 Tel: +34 91 663 67 64
ASIA PACIFIC CANADA

Tel: +852 2793 0699 Tel: +1 888 455 5467
Copyright© 2017 Abbott Informatics Corporation. All brand names and

product names used here are trademarks, registered trademarks or trade
names of their respective holders. STARLIMS is a registered trademark of
Abbott Informatics Corporation. – L2017-09-006-AC-QM

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ABBOTT INFORMATICS

VERSION 2.0 | | SEPTEMBER 18, 2017

The purpose of this document is to list

the main functionality and features

available in STARLIMS solution

for the General and Consumer Products

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

The grouping of multiple samples in a template is done according to a common

Set up standards used in the calibration of equipment, calibration curves, and

FEATURE / FUNCTIONALITY DESCRIPTION

Investigations Start an investigation to re-evaluate a questionable result or when a manager

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

Environmental Monitoring Pre-defined Environmental Monitoring Lifecycle workflows

FEATURE / FUNCTIONALITY DESCRIPTION

Electronic Signatures STARLIMS QM supports electronic signatures. Use electronic signatures to

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

The Specifications Manager displays all existing specifications in the LIMS

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

The STARLIMS -CDS integration, increase automation, minimize data entry

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

STARLIMS supports 2 different technologies for SAP, both with different

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

Support 21 CFR Part 11

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

Enforcements of sequence of steps through My Service Groups Runs

Enforcements of sequence of steps through ELN

FEATURE / FUNCTIONALITY DESCRIPTION

STARLIMS allows users to authenticate when logging in over connections with

FEATURE / FUNCTIONALITY DESCRIPTION

Examples of Invalid records scenarios are:

SUPPORTING ISO 17025

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

Document Control In addition to a Laboratory Information Management System (LIMS) which

Equipment/Instrument STARLIMS provides a full Equipment Management module to manage equipment

The Inventory Manager allows you to manage the consumption, restocking,

FEATURE / FUNCTIONALITY DESCRIPTION

STARLIMS provides several ways to monitor and track data to manage

FEATURE / FUNCTIONALITY DESCRIPTION

Sampling and Material Sample and Test Workflow

Sample Storage and Sample Location Management

Sample Schedules and Sample Points

FEATURE / FUNCTIONALITY DESCRIPTION

FEATURE / FUNCTIONALITY DESCRIPTION

Laboratory Information Management System (LIMS)

Scientific Data Management System (SDMS)

Electronic Laboratory Notebook (ELN)

FEATURE / FUNCTIONALITY DESCRIPTION

Integrated Solution (Cont.) Advanced Analytics

For additional details contact Abbott Informatics.