 Configurable
Workflow: Laboratory Data
Management with
Complete Traceability
STARLIMS’s flexible workflow tools provide
complete traceability and laboratory data management in a manner compliant with the strict
standards of the US Food and Drug Administration Regulation 21 CFR Part 11. All this is possible with no compromise in process
versatility.
The core of the STARLIMS application is the
automated electronic record-keeping function. An electronic
signature is maintained in a relational database--encompassing
test results, equipment settings, and all movements and
activities.
STARLIMS also implements very strict controls
including: stringent access rules, document and data change
controls, transactional or silent audit trails and password
security.
During Sample Login, users describe each
sample using a set of meta-data fields and request tests. Test
assignments and meta-data vary according to the sample type. The
sample login process is extremely flexible. All metadata fields,
their pop-up list properties and test assignment methods are
easily configured and associated with the sample type.
STARLIMS offers several sample login methods
to accommodate diverse testing protocols: batch, routine,
time-based, event-based, calendar and ad hoc. STARLIMS
facilitates assigning disparate workflows and testing protocols
based on login content.
Lab efficiency is enhanced through the
ability to pre-log samples, alerting the lab and enabling it to
prepare for rapid sample processing upon arrival. This
eliminates errors and confusion due to misinterpretation of
handwritten login forms. Several pre-login methods are
available:
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Via a pre-login screen accessed via
Microsoft™ Internet Explorer |
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Via portable devices that use active
synchronization services |
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Via web services that are accessible from
third-party systems (ERP, MES, Clinical Trial Management
Systems, PIMS, etc.) |
 Receive in Lab
Barcodes and handheld devices can be utilized
to generate sample labels and receive samples in a rapid
error-free manner.
Work Assignment
Depending on laboratory-specific business
rules, tasks are assigned to analysts and teams. The Test Design
Wizard enables configuring some tests so they will be assigned
solely to certified analysts. Samples can be grouped into runs
(batches of samples intermingled with QC samples). Utilizing the
STARLIMS Instrument Work Assignment interface, work lists and
instrument control parameters can be sent to analytic
instruments or laboratory robotics systems.
The built-in Work Scheduler calculates the
time needed to complete the tests on the work list. The STARLIMS
Dashboard dynamically displays Key Performance Indicators (KPI)
that indicate current capacity, percent of work completed and
other critical parameters.
The type of result patterns that may be
stored range from simple single- number or text responses, to
arrays of data such as Elisa and chromatography data sets.
STARLIMS’ tight integration with Microsoft Office™ also supports
unstructured results (e.g., notes describing an electron
microscope image).
Built-in calculations, including QC
calculations, automatically determine bias, precision, accuracy,
sensitivity and other pre-determined parameters. Validations
based on specific QC requirements can automate "reflex testing"
or retesting.
Automatic result entry of test data is
facilitated through the DCU, a built- in parsing utility that
enables data capture from multiple instruments or systems.
Virtually any lab or enterprise system can place result files
onto the network, or communicate with STARLIMS via a standard
API. Upon bench approval, results are transmitted to the DCU,
triggering additional calculations and validations prior to
final database storage.
The STARLIMS Data Capture Utility efficiently
eliminates transcription errors, creates a traceable closed-loop
environment, and makes lab data available throughout the
enterprise.
Manual
Data Capture
In manual mode, result-entry screens lead the
analyst through the required workflows. STARLIMS automatically
prompts the analyst to record the necessary data at each step of
the preparation and testing workflow. The screens are easily
configured to reflect the specific test workflow and the
information that needs to be captured for optimal laboratory
data management
The STARLIMS Dashboard dynamically provides
the analyst KPIs regarding the workload, as well as QC KPIs
(e.g., reflex tests, retest, and QC rejects).
Read more about
Lean Manufacturing Processing
Customer Access
Based on a secure web services layer,
STARLIMS enables authorized users to obtain virtually any type
of lab data over the Intranet—from results of analytical
services to sample status and billing information. By giving lab
data consumers direct access to the information they need,
STARLIMS helps labs:
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Accelerate response times
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Minimize status queries
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Reduce manual handling of analytical
services |
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Lower costs |
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Improve customer satisfaction
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Review
& Approval
When all results have been entered and
approval is required, the STARLIMS Dashboard Workflow console
alerts the appropriate personnel to review and approve pending
results. Laboratory-specific business rules determine what
electronic signatures are required before final release. During
the release process, all information related to the reviewed
samples is accessible via the Traceability viewer. This
includes:
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Instrument maintenance records
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Analyst training records
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Records pertaining to the standards that
were used |
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Audit trail records and signatures
gathered at the different workflow steps
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Read more about Laboratory Data
Management in
STARLIMS Product Brochure
Many laboratories are facing increasing
demand for more and more personalized services for laboratory
data management. Typically,
customers are demanding improvements in:
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Report formatting
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Rates, terms and conditions
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Turnaround times
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Sample collection services
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Kit management |
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QC |
The exceptional flexibility and data
filtering capabilities of STARLIMS are important factors that
enable laboratories to meet these requirements. Depending on
their authorization level, data consumers can obtain any type of
laboratory data management: trend analysis, proficiency testing, turnaround time,
laboratory resource planning, QC charting, laboratory output,
billing and invoices, and more. STARLIMS can issue reports that
are personalized for a specific user, role, instrument, group,
laboratory, or location. Any report can be sent to a workstation
screen, routed to a network printer, sent via fax or e-mail, or
published on the organization's Intranet.
STARLIMS uses Business Objects’ Crystal
Reports, an industry standard SQL reporting tool offering
complete flexibility in report design and layout. Other
off-the-shelf desktop applications such as Microsoft Office™ can
also be used to create reports.
To Learn More about STARLIMS Laboratory
Information Management, see also:
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