Pharmaceutical companies must operate within an FDA regulated environment. It is important to have an SOP for validation and documentation for End-of-Life computer systems when transitioning to new ALM and CMS systems. Ashvins was contracted to manage the compliance of these system transitions.

Laboratories monitor and verify their data by using independent control samples to verify the validity of patient results. ASHVINS Group was contracted to develop a comprehensive, secure web-based Quality Control Program that would allow participants to monitor the precision and accuracy of tests’ results on a daily basis.

Laboratories monitor and verify their data by using independent control samples to verify the validity of patient results. ASHVINS Group was contracted to develop a comprehensive, secure web-based Quality Control Program that would allow participants to monitor the precision and accuracy of tests’ results on a daily basis.

Laboratories monitor and verify their data by using independent control samples to verify the validity of patient results. ASHVINS Group was contracted to develop a comprehensive, secure web-based Quality Control Program that would allow participants to monitor the precision and accuracy of tests’ results on a daily basis.

The project consisted of the development of a Health Management Application that runs on Android and iOS mobile phone platforms and interfaces wirelessly (Bluetooth) to glucose devices. The Health Management Application allows users to download real-time glucose data from the device to their phone.

The project consisted of the development of a Data Management System (DMS) which organizes, displays and manages blood glucose data and other relevant health-related information. Data is stored on the web.

The client needed a state-of-the-art web enabled health data management system in order to maintain their market leadership and provide their patients a system that efficiently tracks results and shares data with Healthcare Providers.

ASHVINS Group was contracted by the client to develop the wireless interface with the client’s medical devices that utilize Bluetooth technology. The interface is acting as the primary data extraction point from the system and acts as a source of device data upload for the client’s Data Management Solution.

The project consisted of the development of a Health Management Application that will run on a mobile phone platform and interface wirelessly (Bluetooth) to personal medical devices collecting and displaying health management data for users.

ASHVINS' focus in this project was the development of a Windows based/ Web enabled application that will interface with the insulin delivery device to facilitate the tracking and trending of medical data. Additionally, the application also facilitates sharing of data between patients and Healthcare Providers for remote monitoring.

Clinical laboratories are required by law to monitor and verify their data by using independent control samples to verify the validity of the patient results. The client requested the development of a web-based Quality Control/ Quality Assurance system consisting of a Windows based application, Web based interface and a central repository of data. The project was developed in phases beginning with the creation of the software requirements specifications for both the client and host applications. The client application standardizes the QC processes managed by the laboratory customers, and offers full CLIA documentation, comprehensive selection of QC Rules and immediately accessible data review reports. The system also included LIS/HIS interfaces to facilitate data submission, storage and management.

The client needed to identify and/or develop then validate an information management solution for their Point of Care device. ASHVINS’ role in the project was to determine if a commercial solution was available that could achieve the client’s data management requirements or if development of a custom solution was the optimal approach and then carry the project to implementation (with either a commercial system or a custom system).

To quickly develop requirement specifications and system design documentation for a critical laboratory software product. This comprehensive web-enabled system was essential for supporting improved Quality Control tests performance by their customers worldwide.

This client developed a microarray/bio-sensor instrument that is used to characterize molecular interactions and support the expanding field of Proteomics. ASHVINS' focus in this project was the development of a Windows based graphical user interface to control and acquire data from the new instrument. The instrument is attached to a robot sample handler. The application was required to manage the interaction of both the robot movements and instrument data capture procedures.

The client manages an extensive database designed to store full descriptions of interactions, molecular complexes and pathways. The database stores variables such as small molecule biochemistry to signal transduction, which is abstracted in such a way that graph theory methods may be applied for data mining. The database is used to study networks of interactions, to map pathways across taxonomic branches and to generate information for kinetic simulations. A standard means of submitting data related to biomolecular interactions was vitally needed due to an anticipated large influx of interaction information from high-throughput proteomics efforts including detailed information about post-translational modifications from mass spectrometry.

The ASHVINS Group was contracted to apply Systems Integration IT resources to maximize communications between different application programs, databases and systems.

Biotech client markets a proprietary process to model molecular interactions and capture proteins for drug discovery. The procedure is a time consuming manual process that involves many steps and several different chemical analyses. Individual phases of the process required scientists to program several robots and analytical instruments, each with different software packages. Both the development of the test methods and coordination of the instrumentation were very cumbersome. The client was seeking to automate the process, and create a High Throughput Screening application.

As a research university managing multiple research grants projects, the client found that each department would collect their results on multiple PC's using various software applications. This fragmentation of the data did not provide the university with the ability to access or link similar studies for further analytical review. The university contracted The ASHVINS Group to conduct a thorough review of their current processes and to formulate a solution.

A Clinical Diagnostics company needed three large Enterprise Systems to share customer data to avoid redundant data entry and multiple customer records. All customers had records in (1) the ERP server running DB2, (2) the Quality Assurance Program (QAP) server running Oracle, and (3) in the Customer Call Management System. Each time a customer would call into the diagnostic company, the Customer Support and Services Group would need to access three different systems depending on the customer request, causing delays in response to the customer. In addition, customer records were being created in three different systems making the process prone to errors, adding redundant information that could not be easily updated or synchronized and contributing to overall process inefficiencies that frequently resulted in system application crashes.

The pharmaceutical manufacturing client recently started production in a new plant. Part of the production process included automated ELISA testing using a TECAN Genesis System and components. The ASHVINS Group led the Operational Qualification (OQ) efforts for this important automation project. Operational Qualification is the process of demonstrating that an instrument system and associated software will function according to its specifications and requirements (including FDA regulations such as 21 CFR 11) in the selected environment.

The bio-pharma client was using a custom application to automate testing procedures and data analysis. The software had been developed in-house when the organization was a start-up biotech company. The client was fast moving toward commercialization of their first product and needed to have all applications documented and validated per FDA standards.