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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Core Laboratories

Biotracker™ LIMS is a comprehensive and flexible Lab Information management core platform designed for Diverse Laboratory needs. 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™ LIMS Features:

• Adaptive Workflows
• Configurable Database
• Bio-instrument Communication
• Advanced Searching
• Bio-specimen Genealogy & Chain of Custody
• Inventory Management
• Personnel Accreditation
• Cost Management and Invoicing
• Configurable 21CFR11 Compliance
• Advance Bar Coding
• Resource Scheduling
• Reporting
• Auto-Accessioning
• Protocol Management

Click here for detailed information on Biotracker™ LIMS features.

Biotracker™ Lite – The General Purpose LIMS and Biobanking

Today the greatest challenges faced by small to medium laboratories include managing samples, sample and materials storage and location tracking, managing laboratory instruments including instrument validation and maintenance records and managing data. While solutions are available, small to medium laboratories are also faced with tight capital budgets making most solutions unaffordable.

Biotracker™ Lite provides an easy-to-use, flexible solution for managing all these critical functions at an affordable price. Biotracker™ Lite helps improve your lab’s productivity by increasing your effectiveness and lab efficiency.

Biotracker™ Lite Features:

• Sample Management
• Data Management
• Instrument Management
• Inventory Management
• Administration
• Compliance and Reports

Click here for detailed information on Biotracker™ Lite features.

Biotracker™ for Biobanking

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.

Click here for detailed information on Biotracker™ for Biobanking .

Biotracker™ Lite SaaS

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 yourLIMS 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.

Biotracker™ Lite SaaS Features:

• Focus Budgets on Competitive Advantage rather than Infrastructure
• Save time on deployment
• Pay-as-you-go without upfront capital investment
• Biotracker™ Lite SaaS democratizes LIMS
• Data security and on-demand availability
• Centralized software upgrades
• Better user adaptation and experience

Click here for detailed information on Biotracker™ Lite SaaS features.

Biotracker™ for Biobanking SaaS

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.)

Biotracker™ Biobanking SaaS Features:

• Focus Budgets on Competitive Advantage rather than Infrastructure
• Save time on deployment
• Pay-as-you-go without upfront capital investment
• Biotracker™ Biobanking SaaS democratizes Biobanking LIMS
• Data security and on-demand availability through our hosting services
• Centralized software upgrades
• Customized biobank management solutions
• Better user adaptation and experience

Click here for detailed information on Biotracker™ Lite SaaS features.

Compliance Management

Clarmon’s QAvalid™ is a software solution designed to automate repetitive compliance documentation processes. Configuration management, requirements management, electronic test execution, corrective and preventive actions are integrated under a single platform.

Proprietary linking technology built into QAvalid enables users to connect and synchronize electronic content with the relevant regulations, standards or guidelines, making it easier to maintain documents up-do-date.

The QAvalid Add-In for Microsoft Office allows users to perform controlled document writing, reviewing, approving or testing in the familiar Microsoft Office environment. Users can thus perform most of the common tasks in offline mode and can also add traceability references to connect related content.

The QAvalid software suite includes specialized solutions that are focused on specific quality and compliance processes. By integrating and connecting the complementary solutions companies benefit from a quality process that is streamlined from end to end.

QAvalid provides solutions for:

• Computerized Systems Validation
• Facility Commissioning / Qualification
• Equipment Inventory Management
• Change Management
• Audit Management
• Corrective/Preventive Actions
• Quality Management System
• Environmental Management System