Product Engineering Services & Solutions blending Applied Sciences with Technologies

Life Sciences & Pharma

The Life Sciences and Pharmaceutical works in a highly regulated environment. The regulations demand stringent quality standards that can be achieved by using the innovation in technology.

BAT just does that. BAT provides technological solutions to the problems in Life Sciences and Pharmaceutical Industry.


QoE Ally

QoE Ally is a flexible and versatile application. QoE Ally can be customized to map various workflows followed in the life sciences and pharma industry.

QoE Ally for Pharma Lab and Manufacturing Process Automation

QoE Ally helps the pharmaceutical manufacturing organizations to become paperless. QoE Ally covers all aspects of pharma manufacturing comprising relevant features of Document Management System (DMS), Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Data Loggers, Laboratory Information Management System (LIMS) and others systems used in pharmaceutical companies.

QoE Ally helps automate the complete lab and manufacturing processes in a pharmaceutical plant.

QoE Ally, a versatile execution system for holistic and paperless GxP Compliance in Pharmaceutical plant.

Please visit the QoE Ally page for more information.

QoE Ally for Clinical Trial Management and Research Labs

QoE Ally can automate the workflow and functions of the Clinical Trial Site. QoE Ally for Clinical Trails is a complete Clinical Trial Management System that provides features like Subject Registration, Protocol Creation, Study Management, Screening, etc. that are an integral part of a clinical trial site.

QoE Ally also supports research labs in patient management, sample management and execution of lab workflow to perform lab tests as per study, record study results and create reports.

Please visit the QoE Ally page for more information.


Computer System Validation

As per the US FDA guidelines, third party Computer System Validation (CSV) is preferred over in-house CSV.

BAT has more than a decade of experience in the software development and testing applications in the applied sciences domain. BAT also has knowledge of associated regulatory requirements. BAT has performed CSV for many pharmaceutical organization scoping validation planning, scripting and execution (IQ, OQ and PQ).

QoE Ally for System Validation

System Validation module in QoE Ally can help define qualification and validation protocols and step-wise execution.

Important features like in-line capture of screen shots and camera images helps user capture evidences while executing the step.

In combination with other modules like QMS, DMS QoE Ally becomes an integral solution for system validation.


Analytical Method Development and Validation

BAT team has solid experience in Method development, Method validation and Sample Analysis for the different industrial sectors like Pharma, CRO’s, Health-care, Food Safety etc.

BAT laboratory is well equipped with all the necessary instruments like LC MSMS, LC TOFMS, UPLC, HPLC, UV-VIS, PCR, etc. with wet lab.

BAT has been providing the end to end solutions from Sample preparation till the Analysis methods. All the laboratory processes are based on the standard industrial guidelines like GLP and US FDA.


Bespoke Application Development

BAT offers software development and testing services in a wide range of life sciences areas and applications like medical devices, medical imaging, Genomics, Proteomics, Clinical Trials, BioStorage solutions and so on.

BAT facilitates organizations achieve their “Go To Market” strategy by developing a commercial product from the customers research data / service.

We are well versed with data analytics and reporting and have supported our customers with data presentation, processing and reporting capabilities within their applications. BAT has provided solutions for applications involving micro plate data acquisition, analysis, graphing and reporting.

BAT has experience working in regulatory environments like “IEC 62304 (Medical device software – Software life cycle processes)”, ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes), 21 CFR Part 11 (Electronic Records and Electronic Signatures).


Success Stories

Custom Application Development for a Genomics Research Company

Custom Application Development for a Genomics Research Company

Domain : Life Sciences
Type : Software Product Development

BAT developed a software product for a research company working in the field of genomics. BAT with its domain background helped the customer define the product requirements and further took the complete responsibility of software development. The product involved automating a diagnostics workflow, data analysis using mathematical and statistical algorithms as well as graphical / tabular data representation and predictions. BAT supported the customer by providing documentation in line with IEC 62304.

    Sample Management Solution for a Genomics Research Company

    Sample Management Solution for a Genomics Research Company

    Domain : Life Sciences
    Type : Software Product Development

    BAT developed a web based product for managing multiple samples within a diagnostic workflow related to gene expressions. The project scoped a complete SDLC including requirements definition to final delivery. The product helped the customer manage multiple projects and corresponding samples with ability to perform data analysis with mathematical and statistical calculations.

      Software Development for Microarray company

      Software Development for Microarray company

      Domain : Life Sciences
      Type : Software Product Development

      BAT worked with a global manufacturer of life sciences tools and software for developing software for microplate data acquisition analysis, graphing and reporting. With its multidisciplinary expertise BAT could work with the customer team for understanding, developing and delivering the application requirements. BAT supported the customer by adding new features to the application, enhancements and sustenance support.

        Services

        Software Product Development

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        QoE Ally

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        Testimonials More

        • “The partnership with BAT has been a contributing factor in achieving the business goals for Waters MS division. We are pleased with the commitment and dedication exhibited by BAT practitioners and management. BAT has a team with strong domain and software life cycle expertise. BAT can be proud of its vision statement of solutions that make a difference”

          Richard Chapman,
          Richard Chapman,Waters The Sciences of What's Possible.
        • “Shimadzu engaged Bio-Analytical Technologies (BAT) for an important addition across its software products suite. BAT designed and developed the application where we found that they are reliable service provider who treated Shimadzu as a valued customer. BAT delivered the solution with utmost flexibility yet as planned, on schedule which really made a difference to Shimadzu. At Shimadzu we definitely would consider BAT as a long term partner.”

          Ryuji Nishimoto,
          Ryuji Nishimoto,General Manager Research & Development
        • “The BAT team are very professional, we have good communication and engagement with the team who are able to demonstrate a strong mix of life science application and software technical knowledge. This balance has delivered value in practice, allowing teams to get up to speed with our projects efficiently, and deliver on commitments without the need for constant supervision.”

          Gary Coulthurst,
          Gary Coulthurst,Software Quality Assurance Brooks Life Science