New Modules For CaliberLIMS® 3.0
A number of new modules have been introduced to work in
conjunction with the basic CaliberLIMS® product. Some of these add-on modules assume
the role of a mini ERP for the laboratory, by aiding in the management and
control of the lab resources. The Caliber products designed for different workflow requirements will have the necessary modules configured into them. The add-on modules currently available are listed
below to illustrate the potential and utility of CaliberLIMS®.
Caliber Mail Module:
The Caliber Mail Module is a closed user group mail system for
CaliberLIMS® users. It enables users in the chain get mail messages
among them. All the attributes of a regular mail system like inbox,
compose, reply, address book etc. are available. Multi-cast or
broadcast mails are possible through multiple selection of addresses
from the address book. Alert for new mail arrival is provided on the
user homepage itself.
Electronic Notebook Module:
The electronic notebook is an electronic replacement for
the analyst’s notebook. The details of the sample under test will be
directly on the notebook pages in a locked form. Any entries or notes
made on the notebook can be modified only by the allottee of the
notebook and any the made will have to be authenticated the analyst’s
electronic signature along with reasons. All the modifications will
be tracked for changes. Test result entry and result calculations can be
made through the electronic notebook. The notebook makes it easy for the
analyst and minimizes the transcription errors.
Stability Test Module:
The Stability Test Module provides for stability tests over varying
periods of time with varying intervals, as defined in the Stability
Test Protocol. Stability Test Module provides for Pre-Registration of
Stability Test Protocol, Automatic generation of A.R. Nos. as per
Protocol, Automatic Calculation of test results, Individual COA
printing, One click graphical representation of behavioral, Audit Trails
and 21CFR Part 11 compliance. The results of the tests carried out as per
the protocol are plotted in a graph along with the values to
give the picture of observed stability of the product both textually
and graphically, the behavioral trend of a product over a period of time.
Analyst Qualification Module:
The Analyst Qualification Module Facilitates
qualifying the analysts about their expertise through a system
of qualifying tests and comparing results with benchmark values. The
benchmark values may be the standard reference values available for
the selected product or may be the average of the results produced by
an expert analyst in multi-cycle testing of the product. Provision
is made for comparing the candidate’s results or even readings
with the benchmarked results.
Training Calendar Module:
The Training Calendar Module provides for proposals
and approvals for training. The subjects could be induction course,
basic training / advanced training / refresher course on a product / instrument,
or any other subject. Nominations can be made of the prospective
trainees and schedules can be proposed. Approved trainees, training courses and
schedules will be listed as a calendar.
Instrument Management Module:
The Instrument Management Module facilitates asset management, calibration
schedules and records. All instruments and modules will be registered
and the calibration schedules will be recorded and monitored for fail-safe
implementation. Provision is also available for instrument log keeping.
Columns Management Module:
The Columns Management Module enables registration of column
application, individual column IDs, column assignment and
performance tests.Columns will be subjected to an initial
acceptance test based on the performance criteria specified for the
assignment. The module also provides for regular usability tests
and usage records, column regeneration and reinitiation where
acceptable. All re-initiations will be tracked with full details.
Unusable columns can be discarded.
Chemicals Management Module:
The Chemicals Management Module enables registration of
all chemicals of all forms and grades and individual lots received
from time to time. All kinds of consumption, including for reagent
preparation, are tracked and stock positions updated instantaneously.
It also provides for Inventory control where maxima and minima have
been specified at the time of registration, and also alerts about the
stock crossing the stock limits. Provision is also made to reconcile
the unaccounted / unaccountable consumptions and to close the
Reference Standards Module:
The Reference Standards Module enables record keeping
of the reference standards received and consumed in the laboratory
for the sample analysis tasks. The module provides for the
registration of each reference standard and the individual lot
received under it. Consumption is recorded and stock tracked.
Provision is also made for terminating a reference standard when
Working Standards Module:
The Working Standards Module enables preparation of working standards
in the laboratory by multi-cycle testing of the concerned product
sample. All working standards so prepared in the laboratory are
registered and there consumption tracked. Retest schedules are
specified and monitored for implementation.
Microbiology Module :The Microbiology Module enables registration of all
the reference cultures received in the laboratory along with the relevant
particulars. It keeps track of the preparation of the seed cultures and working
cultures from the reference culture, by registering each individual culture
with a unique reference number.
OOS Module :The OOS Module helps in studies concerning the samples
that proved to be out of specifications. The Module provides for registering OOS Templates for the analyst’s
checklist and the supervisor’s opinion about the causes that can be attributed
to the failure(non-conformity) of a
sample. The Templates will be obtainable whenever a sample fails in a test.
Volumetric Solutions Module:
The Volumetric Solutions Module takes care of information
management regarding the Volumetric Solutions used in the laboratory. It covers
Registration, Preparation, Standardization, and Usage of Volumetric Solutions,
Each Volumetric Solution shall be registered by its name
and properties to enable identify each uniquely. The composition of each
Volumetric Solution is defined and Working Solutions shall be prepared of each
Volumetric Solution for day-to-day use. Each Lot shall have a defined validity
period, during which it may be standardized more than once. Every usage of every
Volumetric Solution shall be recorded. Usage of expired Solutions or Solutions
whose standardization has expired may be disallowed. Reports will be generated
based on the user defined content and formats.
SAP Interface Module:
The SAP Integration Module seeks to work in conjunction
with SAP system and to integrate the laboratory transactional information with
master information provided by SAP. The module covers re-registering SAP
provided particulars of sample types, products, specifications and tests, with
or without additional particulars to suit LIMS, and appropriating SAP masters
into LIMS, registering SAP Samples into LIMS, monitoring master data changes
and their impacts to ensure availability of only the right data for the right
task, and generating the relevant reports.
Once a SAP sample is registered into CaliberLIMS® with all the right particulars, the further course
of the sample would be the same as for any other LIMS registered sample.
The Usage Decision based on the sample’s conformance, and
the Stock Posting are recorded in LIMS and then conveyed to SAP.
Label Printing Module:
The Label Printing Module provides for various activities
involved with automatic label printing like Registration of a Label Name
(Format) with the required field names and environmental settings, Label Data
Entry, facility for identifying the text positions, and Print Orders.
The data to be printed can be directly invoked from the database
for selected fields of the label, and for non-routine fields it may be entered
manually. The module also provides for making changes to the data as required,
re-print orders, audit trails and reports in a user-defined format and content.
A stand-alone version of Label Printing Module is also
available under the brand name “CLAPS”, which can be used independently
Lab Documents Management System:
Lab Documents Management system: a special module has been added in LIMS 3.0 for the laboratory to maintain/ Manage the lab specific documents like SOP/ STP, Training manuals, MSDS and sample related supporting documents. Documents are categorized in such a way that specific documents required for the analyst will be appearing as a hyper link at appropriate location/ module. For e.g.: if a chemist has been assigned a sample of product ABC, he /she would get a link to view the STP /SOP of the product ABC. If a chemical say, Benzene is being used, he/ she would have an MSDS of the chemical. This has document version control in place.