Core LIMS for Core Laboratories

What sets Ocimum Biosolutions’ Biotracker™ LIMS apart for Life Science Research and Development operations?

Completeness with flexibility!

Only Biotracker™ offers a LIMS designed with and for research investigators. Our customers asked for adaptive workflows, configurable database, bio-instrument communication, advanced searching, bio-specimen genealogy & chain of custody, inventory management, personnel accreditation, cost management, configurable 21CFR11 compliance, and the list of LIMS features goes on.

Biotracker™ Core Features:

Adaptive Workflows:

Drag & Drop workflow building simplifies the definitions of your protocols and also provides a unique Dynamic SOP. What this means is as you build your experimental design and associated protocols, Biotracker™ can simultaneously build the workflows and SOP. So, no longer is your SOP a static document, it is dynamic plus you can revert to an earlier protocol and Biotracker™ shows the present SOP with the older version side-by-side with the differences highlighted so there is no guess work on your part. Based on research projects, customer orders, or development campaigns Biotracker™ LIMS allows investigators the luxury to define fixed or flexible processes. Once approved, protocols are executed ‘as is’ or can be submitted to an approval process. In research, you are performing novel research where protocols are being developed. In production (service, clinical, diagnostics), you are performing validated processes where compliance and quality are absolutely required and assured with Biotracker™.

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Configurable Database:

Properties describe bio-samples, biomarkers, processes, primers, oligos, results, and in fact all objects in Biotracker™. The adaptive design and flexibility of Biotracker™ affords you a LIMS that is tailorable to your laboratory requirements. For example, you can support any bio-sample: Fresh Whole Blood for DNA, Fresh Whole Blood for cells and Frozen Whole Blood for DNA, Purified DNA, Serum, Plasma, Urine, Cerebro-spinal Fluid, Peripheral Blood Mononuclear cells, cell lines, etc. And the properties that describe these entities can be adjusted or added by you to exactly suit your needs without any programming!

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Bio-instrument Communication:

Biotracker™ LIMS has already integrated many existing bio-instruments and as technology advances such as Next Generation Sequencing or innovative drop-let technology, Ocimum continues to support instrument system bi-directional communications.

• Qiagen Autopure LS
• Biomek FX
• Spectrophotometers like the NanoDrop and 2100 Bioanalyzer
• Illumina
• GenomeLab SNPstream
• PCR (AB / Bio-Rad, Agilent)
• Sequencing (AB)
• Luminex
• AutoGenomics
• GelPics
• Tecan Genesis
• Biomek Fx
• TaqMan 7900
• Affymetrix Genotyping
• Parallel GenFlex
• Sequenom

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Advanced Searching:

Biotracker™ LIMS employs advanced search filtering to allow advanced data searching. Based on straightforward query structures, Biotracker™ incorporates all system-defined properties and user-defined properties into querying and retrieving your data quickly and efficiently. Filters are dynamic, shared, or unique for each investigator. Biotracker™ streamlines execution because Querying was designed for SQL challenged. There is no programming necessary to make use of the powerful capability.

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Bio-specimen Genealogy & Chain of Custody :

The Biotracker™ for Biobanking solution allows your organization to collect, store, process and distribute biological materials in your BioRepository as well as associate the critical demographic data, clinical data, and biomarkers to these biospecimens. Within its BioRepository solution, Biotracker™ maintains the biospecimen genealogy with the ability to provide workflows for macromolecule DNA/RNA extractions. In general, these “biological materials” are human biospecimens – such as tissue or blood and the “Meta data” is the clinical information pertaining to the donor of that particular biospecimen. Hence, in a HIPAA compliant way, the ability to annotate biospecimens with diagnosis, stage, patient demographics, etc. is built-in. Biotracker™ also supports the Histology Management of tissues from animals or humans, cells and bacterial cultures as well as having significant capabilities for managing TMAs and LCM and their associated images. In fact, Biotracker™ can be used to build TMA libraries by Disease type for Biomarkers with annotations per spot on the TMA slide image. More…

Biotracker™ LIMS supports:

• Aliquots
• Extraction Derivatives
• Check in/out with Chain of Custody (CoC) Transfers

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Inventory Management:

You know inventory management is important. With Biotracker™ LIMS, now you can assure adequate lead times for consumables, check-in/check-out for sample transfers, track expiry dates, lot container locations, auto-decrement of stock levels when used in an experiment, and maintain instruments, glassware, constituents, volumes and concentration. Forward and Reserve Lot Genealogy is traceable, along with maintaining information on storage physical location and chemical conditions. Now, R&D can enjoy the benefits of inventory control, as well as integrate with your corporate inventory system, if so desired.

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Personnel Accreditation:

To support CLIA and other laboratory and regulatory requirements, users defined in Biotracker™ LIMS are assigned competency certifications. When Protocols are approved for laboratory use, Biotracker™ validates the training records of the assigned resources. This training validation is assessed throughout the life cycle of your operation so you stay in compliance.

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Cost Management and Invoicing:

Biotracker™ can record the costs of consumables, reagents, instruments, instrument maintenance, man-hours, hourly salaries, development costs, equipment amortization (specified as overhead cost, the field should be editable as some customers are billed these overhead costs and others are not), etc., and use the same to calculate cost for an activity / time period / project. For Academic Core Labs, Biotracker™ can output invoices for your requestors based upon Internal or External Customer price lists.

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Configurable 21CFR11 Compliance:

One of the key provisions in 21CFR11 is that “Companies should use secure, computer-generated, timestamped audit trails to independently record the date and time of operator entries and actions that create, modify or delete electronic records. Record changes should not obscure previously recorded information.” In accordance with the facility for generating a record of electronic signatures, Biotracker™ records and shows the sequence log of activity, various actions, researcher names, time and date and approval or rejection of data.

Compliance is configurable to audit silently, requiring an electronic signature, or if compliance is not required auditing can be turned off and is configurable by function.

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Advance Bar Coding:

You can create barcodes for inventories, samples, protocols, and plates and then use the 1D or 2D bar code generated to quickly navigate and drive Biotracker™ with a bar code reader. The “Barcode Label Design” window allows WYSIWYG (What You See Is What You Get) barcode creation and printing of labels.

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Resource Scheduling:

Resources in an organization are shared entities that can now be used effectively and efficiently with Biotracker™ LIMS. Researchers can monitor and track usage of resources and (subject to availability) schedules them in accordance with their time line. Resources are divided into personnel, instruments, consumables and laboratories. Biotracker™ provides researchers with an option to check the availability of resource(s) in a time slot specified and also to schedule the utilization of the resource(s), if available.

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Reporting:

Biotracker™ has a built-in report generator to customize existing reports or create new reports.

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Auto-Accessioning:

Biotracker™ LIMS provides autoaccessioning of biological samples from a spreadsheet-like file or a text file containing all the required and relevant data for samples. Received samples are normally inspected visually for volume, presence of relevant and required information, physical appearance of the sample, etc. Samples passing the visual inspection are made available for various processes that take place downstream and the Customer is notified via configurable e-mail for those samples that fail.

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Protocol Management:

A protocol is a series of steps that are followed in order to conduct all or part of some experiment(s) or processes. Protocols allow Biotracker™ users to perform experiments in different ways, based on equipment, inputs, and approvals specified by the scientists and investigators. What makes Biotracker™ unique is that it can employ a configurable and Dynamic SOP which means that as a protocol is developed; Biotracker™ simultaneously builds the associated workflow and SOP. So, no longer are SOPs static documents, they are dynamic! In fact, an authorized user can choose to revert to an older protocol and Biotracker™ will show the current SOP version side-by-side with the older version and even highlight the differences for you removing any guess work on your part. A protocol has a unique number, its name and version and specifies inventory, samples or plates, and instruments in order to be executed. Outputs from protocols are definable and stored with the results, observations, and annotations. Protocols can also be shared among multiple laboratories.

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Biotracker™ – The LIMS for Life Sciences Research

In R&D, you never say never.
Your experiments are in fact novel ventures…
Outcomes often yield new measurements…
Your processes are continuously evolving…
You state the hypothesis and rationale for the given project…
You define your strategy of your protocols, and then you begin to record results for your experimental runs…
Some work, some don’t. But the success is measured at the project level, not at the sample or experiment level.

Traditionally, LIMS vendors focusing on multiple Industries adopt a shoehorn approach for squeezing a sample-centric LIMS into a project based environment. It just does not work in research. A LIMS must interweave to meet the needs of a researcher.

Biotracker™ is designed keeping you in mind.

 

 

Biotracker™ provides an adaptive platform to capture your research findings. Rather than dictate, Biotracker™ captures your work in an organized structure. Your data is secure. Here you control the viewing of your data to other scientists. You choose the level of regulatory compliance that is required. If the attribute describing a type of sample requires more information, then just add them and Biotracker™ will logically store the information describing the biospecimen or the subject. Most importantly Biotracker™ supports the core feature set that is needed to improve the productivity of your laboratories.

Biotracker™ key features in a nutshell: Laboratory Administration, Project Design and Scheduling, Work Flow and Process Tracking, Experiment Tracking, Analysis and Archival, Sample Management and Chain of Custody, Hierarchal Location Tracking, Plate Tracking, Inventory Management and Tracking, Special Inventories, Forms and Fields, Instrument Integration for Automated Data Capture, Report Builder, Cost Estimation of Projects, Invoicing, and Reports of Raw Data and Integrated Results.

Your laboratory is a critical component of your life science research operations.

As science advances, so should your LIMS.

Enhance your productivity; Accelerate your Research

Biotracker™ for	Laboratories
Core LIMS	Genomics and Proteomic Core Labs
BioBanking	BioRepository and DNA/RNA Extraction Lab
DNA Analysis	Sequencing and Genotyping Labs
Gene Expression Analysis	Microarray Analysis and Real-Time PCR Labs
Proteomics	Protein Identification, Profiling, and Characterization

Product Sheet

• Biotracker™ for BioRepositories

View all related literature…

The Biotracker™ for Biobanking solution allows your organization to collect, store, process and distribute biological materials in your BioRepository as well as associate the critical demographic data, clinical data, and biomarkers to these biospecimens. Within its BioRepository solution, Biotracker™ maintains the biospecimen genealogy with the ability to provide workflows for macromolecule DNA/RNA extractions. In general, these “biological materials” are human biospecimens – such as tissue or blood and the “Meta data” is the clinical information pertaining to the donor of that particular biospecimen. Hence, in a HIPAA compliant way, the ability to annotate biospecimens with diagnosis, stage, patient demographics, etc. is built-in.

Biotracker™ capabilities for:

• Medical Research Facility
• Pharmaceutical or Biotech

Biotracker™ also supports the Histology Management of tissues from animals or humans, cells and bacterial cultures as well as having significant capabilities for managing TMAs and LCM and their associated images. In fact, Biotracker™ can be used to build TMA libraries by Disease type for Biomarkers with annotations per spot on the TMA slide image.

If you are in a Medical Research Facility, the following capabilities of Biotracker™ for Biobanking apply:

• Samples arrive at your facility and Biotracker™ captures shipments from Surgery, Phlebotomy, the Floors, or Clinics as well as distribution from the BioRepository storage, based upon Principle Investigator (PI) requests per their Internal Review Board (IRB) approved protocol.
• Biotracker™ has a highly flexible Location Management hierarchy to accommodate a single Biobank or multiple Biobanks spread out across a single campus or across many sites, enabling a “Virtual BioRepository Network.”
• With a highly flexible and published Applications Programming Interface (API) layer, Biotracker™ provides interoperability with existing disparate systems so that Meta data annotation need not be manually entered, but interfaced with Electronic Medical Record (EMR), Pathology software for diagnosis, and systems which house patient demographics – all with an eye for complying with HIPAA. So, while annotation of biospecimens can be done manually, automating this task via interfaces eliminates the chance of transcription errors.
• To facilitate querying of biospecimens for disease type, demographic, etc., Biotracker™ provides a flexible Controlled Vocabulary (CV) using sources such as SNOMED, WHO or the caBIG® Thesaurus. In addition, the system supports synonyms so that searches return a whole collection rather than a small subset which can happen when free text entry is allowed.
• Biotracker™ can check the IRB protocol associated with the Requestor to see if the amount of specimen and type (Fresh, Frozen, etc.) requested is approved and if Patient Health Information (PHI) is allowed.
• Tissues will be harvested with Informed Consent from surgery or a clinic while blood/serum may come from Phlebotomy, the floors or the clinic and the LIS may only associate one sample ID even though there can be 1 to many blood draws from a single patient.
  • Biotracker™ can parse an HL7 communication from the LIS and create unique IDs, which are critical for location management in a Biobank, for these “virtual” specimens.

    “Virtual” in this context meaning that the specimens are in transit.

  • Once the specimens arrive at the Biobank, Biotracker accessions the unique identifier associated with each vial and they become physically received.
  • Informed Consents are associated with the parent specimen as well as with all downstream samples so if consent is withdrawn, it is easy to locate all samples associated with that patient for removal and disposal.

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If you are in a Pharmaceutical or Biotech, the following capabilities of Biotracker™ for Biobanking apply:

• Samples arrive at your facility and Biotracker™ for Biobanking captures both requests for biospecimens as well as actual shipments to and from the BioRepository storage.
• Biotracker™ can import specimen and patient/donor information associated with clinical studies from the CRO or collaborating hospital and provides an easy way to map this data, doing so with an understanding of a Controlled Vocabulary, as each organization may have their own syntax.
• To facilitate querying of biospecimens for disease type, demographic, etc., Biotracker™ provides a flexible Controlled Vocabulary (CV) using sources such as SNOMED, WHO or the caBIG® Thesaurus. In addition, the system supports synonyms so that searches return a whole collection rather than a small subset which can happen when free text entry is allowed.
• Biotracker™ has Study templates which allow the Biobank to associate the Meta data with the received specimens from a clinical trial so that Biotracker™ can become a lynchpin in Biomarker characterization, as all of the pertinent data resides in one data source

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There may be multiple specimens submitted from a single donor and each of these may be associated with multiple extractions and derivatives. Sample accessioning occurs as individual samples are created. Biotracker™ has a built-in barcode designer for 1 and 2D barcodes. As samples are subjected to processing, results/data generated need to be recorded for the samples and their progeny (daughter samples) in defined steps of a given process.

Donor » Specimen (Virtual) » Sample (Progenitor) » Derivative

Biotracker™ manages biological materials shipped from your customers through registration of individual samples, establishment of relationships with biographic information and other samples, and recording of sample processing attributes. The samples created in the database need to be reconciled against the physical samples in inventory and released into the production pipeline.

*cancer Biomedical Informatics Grid, caBIG and the caBIG Logo are registered trademarks of HHS used in connection with the National Cancer Institute’s caBIG® program.

With the ever increasing amount and diversity of information being analyzed and managed in Life Sciences, labs now have specific and unique needs. We cater to diverse customer needs which include BioRepositories, Research Centers, allied Biotech & Pharma Industries, Core-Facilities, Large Instrumentation firms, Hospitals & CROs, Genotyping & Microarray labs. Some of these entities are relatively new in the long history of Life-Sciences, whose functions have emerged from an unprecedented increase in data and to meet diverse R & D requirements. As allied technologies and support systems for R & D processes continues to change and progress, there is a need for specialized information management and dissemination solutions. We have extensive experience and understanding of these environments. Being an integrated global genomics company ourselves, our cutting-edge automation solutions cater to the growing needs of Life Science Labs.

Biotracker™ is a specialty Lab Information Management Solution (LIMS) for enhancing productivity and effectiveness in life sciences research laboratories. Biotracker™ addresses the challenges of supporting multi-disciplinary labs, collaboration and data management needs. Biotracker™ offers several specialty modules that address the needs in life sciences research laboratories performing Biobanking, Gene Expression, Genotyping, DNA Sequencing, and/or Proteomics.

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Biotracker™ Lite is an efficient LIMS solution for Sample Management, Data Management, Inventory Management and Instrument Management, which is designed to satisfy the needs of small to medium laboratories. Biotracker™ Lite enables you to easily manage samples and their associated data as well as tracking amounts, concentrations, availability, storage conditions and location of samples, reagents, enzymes, precursors, chemicals, labware, etc. available in your organization. Additionally, Biotracker™ Lite provides an easy-to-use facility for managing your laboratory instruments including their validation and maintenance records. Utilizing Biotracker™ Lite will improve your lab’s performance and enable you to increase your efficiency and effectiveness.

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Biotracker™ for Biobanking solution allows your organization to collect, store, process and distribute biological materials in your BioRepository as well as associate the critical demographic data, clinical data, and biomarkers to these biospecimens. Within its BioRepository solution, Biotracker™ maintains the biospecimen genealogy with the ability to provide workflows for macromolecule DNA/RNA extractions. In general, these “biological materials” are human biospecimens – such as tissue or blood and the “Meta data” is the clinical information pertaining to the donor of that particular biospecimen. Hence, in a HIPAA compliant way, the ability to annotate biospecimens with diagnosis, stage, patient demographics, etc. is built-in.

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Biotracker™ Lite SaaS offers you an easy, “pay-as-you-go” solution for all your current and long-term research needs. Trust us to manage your data securely with anytime and anywhere on-line access to your critical lab information. Instead of making a costly investment in hardware and software for your LIMS system, you can just use your current computer and internet access to easily manage your lab information anytime, from any location. Biotracker™ Lite SaaS can be licensed for a single user or for a group of users.

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Biotracker™ Biobanking SaaS is a fully scalable, configurable, customizable, complete biobanking solution. And now that it is available as Software As A Service (SaaS) you will be able to utilize the system without the need for increasing your infrastructure. Biotracker™ Biobanking’s specialized features include a Web-Based Requester Module, Donor/Patient and Biospecimen Management with full Genealogy, Unlimited Meta Data Annotation, Controlled Vocabulary and Synonyms, Data and Location Management, TMA, CMA, and much more. Biotracker™ Biobanking is caBIG® Bronze Certified, providing the highest degree of integratability and interoperability, and supports Regulatory Compliancy (HIPAA, 21CFR11, GxP, CLIA, etc.)

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QAvalid™ is a Web and MS Word based software suite designed to manage and automate quality and compliance processes. An alternative to paper based or manual systems, QAvalid™ is both efficient and simple to use, combining the control and compliance of traditional tracking databases with the flexibility of manual systems.

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*cancer Biomedical Informatics Grid, caBIG and the caBIG Logo are registered trademarks of HHS used in connection with the National Cancer Institute’s caBIG® program