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 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 can automate the workflow and functions of the Clinical Trail 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.
QoEAlly for Clinical Trial Management and Research Labs
QoE Ally can automate the workflow and functions of the Clinical Trail 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.
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.
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.
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).