Client Profile: A global clinical and medical device company that develops personal and portable medical devices. The devices are Bluetooth enabled glucose meters for continuous glucose monitoring. Being one of the most versatile technologies in the wireless market, the Bluetooth technology was chosen by the client to address performance requirements specific to the medical application and because it is a particular good fit use for models demanding high mobility, long battery life and limited infrastructure support.

Technologies Used: Visual C++, Delphi, Bluetooth Technologies, UML, Broadcom Bluetooth Development Toolkit, Mercury Test Director

Project Summary: 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 interface is architected around a core Bluetooth SPP communication engine developed in-house. This engine is wrapped into a data validation layer and all was integrated into a data management hander framework. The layer design of the interface provided data de-coupling and low risk upgrades. The Bluetooth communication layer can be easily upgraded to keep the pace with the latest Bluetooth protocol developments. Thus, the engine was upgraded from the original Bluetooth 1.1 implementation to 1.2 and later to Bluetooth 2.0. The Bluetooth has proven itself to be a reliable and secure communication protocol.

The implementation of the Bluetooth protocol for the device communication gave the client an edge in the industry. It is clear that medical devices and medical data management products benefit from the advantages provided by wireless technologies.

MICROARRAY INSTRUMENTATION SOFTWARE

Client Profile: A biotech company developing new technology for the Life Science Industry.

Technologies Used: Borland Delphi, Borland Interbase, XML, C++, Mercury Interactive TestDirector / WinRunner

Project Summary: 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 and required an application to manage the interaction of both the robot movements and instrument data capture procedures.

• Phase 1: Created a team consisting of members from the industrial design company, the biotech client and Ashvins to develop the Software Requirements Specification.

• Phase 2: Developed the Design and Architecture of the system utilizing established UML Best Practices.

• Phase 3: Implementation of the solution, testing/validation processes, change control procedures and defect tracking.

Throughout the life of the project, communication was critical since both the firmware for the instrument and the software was developed concurrently. Constant interaction between the biotech company, the industrial design company, and Ashvins ensured a successful project.

An application was developed with an easy to use graphical interface that allows a lab technician to learn and use the application in less than a day while orchestrating complex experiments in less time than competing systems.

REQUIREMENTS ENGINEERING, SYSTEM ARCHITECTURE AND DESIGN DOCUMENTATION FOR CLINICAL DIAGNOSTICS APPLICATION

Client Profile: An established manufacturer of clinical laboratory reagents, quality control products and instruments for in vitro diagnostic testing used to confirm the safety of blood supplies.

Technologies Used: Rational Unified Process, Use Cases, UML, Mercury Interactive TestDirector/WinRunner.

Project Summary: 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.

• Using best practice RUP processes and Use Case Analysis, The Ashvins Group produced a detailed Software Requirements Specification (SRS). This step established clear, detailed documentation of the system goals in order to manage and to achieve an effective and efficient software development process.

• Prepared complete Design and Architecture Documentation with GUI templates and model diagrams to aid accelerated implementation of the software coding and development.

• Provided independent Test Administration support including Quality Assurance planning, software test case development, system & integration testing, change control procedures, defect tracking and coordination of field beta testing.

Overall the IT skills and medical scientific experience of The Ashvins Group assisted the client in developing an innovative QC system for their laboratory customers.

OPEN SOURCE SOLUTION TO SUPPORT PROTEOMICS RESEARCH

Client Profile: A prominent Proteomics Research University whose focus is on the study of biomolecular interactions.

Technologies Used: JBoss (Java J2EE), Apache AXIS (SOAP)

Project Summary : 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.

Ashvins developed a custom open source solution that entailed web service API development. This involved creating independent application components and making them available for use across the Internet. Developers of Internet-based applications incorporate this service into their applications for the benefit of their end users in an unobtrusive and seamless way. This interface allows Integrated Development Environments (IDE) such as JBuilder and Delphi to generate a dynamic listing and access to the API utilizing the native SOAP services that are used to communicate and integrate with their internal applications. The API is made available to developers via a Web Service. The SOAP API provides a modular, more flexible, and higher-performing interface to increase the accessibility of the database.

CLINICAL DATA MANAGEMENT SYSTEM INTEGRATION

Client Profile: A growing pharmaceutical company seeking to improve clinical data management between internal company laboratories and contracted outside Clinical Research Organizations in order to accelerate the process of bringing new drugs to market.

Technologies Required for Implementation: RUP, Java, JSP, Websphere, Oracle Clinical, Oracle Thesaurus Management System, SAS

Project Summary: The Ashvins Group was contracted to apply Systems Integration IT resources to maximize communications between different application programs, databases and systems. The project included:

• A user-friendly interface to facilitate the capture of data from clinical trials, the ability to set-up/track and manage Phase I-IV clinical studies, the ability to custom configure clinical studies based on the study/specifications and reports generated utilizing industry standard reporting tools.

• The system automated information flow and accessibility to data generated by multiple sites (even outside CRO's) through the use of the batch load function of Oracle Clinical, and synchronization to the web-based user interfaces.

The client was able to achieve immediate access to clinical research data through the use of the improved web-based system. The advanced data management system allows the client to dramatically improve overall management of the clinical trials process and additionally provides detailed documentation along the way.

DRUG DISCOVERY AND HTS PROCESS AUTOMATION

Client Profile: An emerging drug discovery company utilizing proprietary molecular interaction modeling and protein capture technologies.

Technologies Used: Java, J2EE, Borland Application Server, Apache, Borland JBuilder, Oracle

Project Summary: 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.

Ashvins was contracted to manage the requirements gathering and documentation, architect the automation application, and develop project schedules for the different phases of development. A team with members from Ashvins and the client developed a web based scheduling application that coordinated all the robotic movements and extracted the data from the different analytical instruments. The data acquired is stored in a central database where it is statistically analyzed and collated for reactivity. Experiments are batched ahead of time and processed through out the day. The application monitors and provides instant feedback as to the status of the experiment via a secure web portal interface.

As a result, the client achieved a streamlined process and quadrupled their processing volume with fewer resources. Scientists are able to configure their experiments and monitor them remotely, even when off site.

COMPREHENSIVE QC SYSTEM SUPPORTING GLOBAL LABORATORY CUSTOMER BASE

Client Profile: An industry leader in the field of clinical diagnostics who supplies clients with products and services that support laboratory Quality Control (QC) processes.

Technologies Used: C/C++, Oracle, Oracle Forms and Reports, PERL, PL/SQL, Korn Shell, OCR for Forms, Rightfax, Adobe Distiller, Borland Delphi, Borland Interbase, Crystal Reports, WinRunner and AIX.

Project Summary: 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 QC application 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 Westgard Rules and immediately accessible data review reports. The host system stores and manages an Oracle relational database.

Laboratory QC Systems are regulated by the FDA. These regulations require proper documentation and testing prior to release. Testing protocols, test cases and validation documentation were developed to ensured FDA regulation compliance.

The entire system entails the acceptance of QC data via mail, fax, electronic data transfer and direct data submission via the Internet/Web based service from the client application on a daily and/or monthly basis from labs around the world. Mailed and faxed data is processed using Optical Character Recognition technology and imported to the Oracle relational database.

Received data is stored in a central repository categorized by laboratory parameters. The data is analyzed for statistical validity and compared to other laboratories using similar test methodologies. Report pdf files are generated and are either printed for mailing or sent to users electronically.

WEB-BASED SYSTEM SOLUTION FOR RESEARCH GRANT MANAGEMENT

Client Profile: A large university medical school handling multiple research studies and grants.

Technologies Used: Rational Unified Process; Java; J2EE; Oracle; Websphere; JSP

Project Summary: 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.

The Ashvins Group prepared a comprehensive list of recommendations that included the implementation of a large web-based system that tracks the state's primary health care network. The system was designed to identify and forecast the needs for preventative medical services and incorporate this knowledge into the student curriculum for predoctoral training in primary health care.

The Ashvins Group undertook an extensive data modeling endeavor for the system. The data model was realized into an Oracle database on the host server. Ashvins also implemented the application server portion of the project. We undertook conception and system requirements analysis using the Rational Unified Process, and then subsequent elaboration and construction phases of the project.

As a result, the university can formulate comparative studies of similar projects. Having one database has also minimized data entry as multiple users were previously entering like information into separate databases.

ERP INTERFACE / SYSTEM INTEGRATION

Client Profile: An established Clinical Diagnostics manufacturing company.

Technologies Used: Java, J2EE, Websphere, Borland Delphi, Borland JBuilder, PL/SQL, DB2, XML

Project Summary: 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 Management System running Paradox. 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 Ashvins Group developed an electronic data interface to integrate all three systems and developed a Graphical User Interface that performs all required functions to interact with the three systems. SQL modules were developed and integrated into the ERP System that would update the QAP System automatically. PL/SQL modules were added to the QAP database to accept the data update, automatically create a new record for the customer in the QAP database, and generate customer documentation. Custom SQL queries were developed for the Customer Management Database that would retrieve customer laboratory information and automatically fill in all the required fields for a customer record.

As a result of the new integrated application and comprehensive GUI, the Customer Support and Service Group was able to increase customer satisfaction by cutting the response time 75%. In addition, the most current information and data was immediately available and consistent between sources. Application crashes were no longer an issue and data entry was streamlined by eliminating data entry duplication. Data errors were significantly reduced and the process of customer data management enhanced.

DISASTER RECOVERY PLANNING FOR CRITICAL SYSTEMS

The Ashvins Group developed the Disaster Recovery Plan, documented all areas of the systems/applications/networks that support critical data, developed standardized Back-up and Recovery Procedures, trained technical staff on all new procedures and tested the plan to assure goals were achieved. The client can now rest assured that their critical data is always retrievable in the event a disaster should occur.

SYSTEMS VALIDATION AND OPERATIONAL QUALIFICATION

Client Profile: A pharmaceutical manufacturing company implementing laboratory automation instrumentation to support production operations.

Technologies Used: FDA Regulations/Standards, IEEE Documentation Standards, Computer Related Systems Validation (CRSV) Methods, Project Management Techniques

Project Summary: 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.

Working with the client, The Ashvins Group prepared the OQ Validation Plan, assisted during the execution of the OQ protocols and prepared the Summary of Results. The client was able to capitalize on the Ashvins’ laboratory automation expertise, knowledge of FDA regulations and documentation skills to efficiently document and implement their new instrument system.

RETROSPECTIVE VALIDATION FOR CUSTOM APPLICATION

Client Profile: A bio-pharma company involved in drug discovery and moving into pharmaceutical manufacturing.

Technologies Used: RUP, IEEE Recommended Practice for Software Requirements Specifications, UML, and Rational Rose Modeling Tool.

Project Summary: 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.

The Ashvins Group consulted with the client to understand the functional requirements associated with the custom application and to review all existing design and development documentation. By working both with the end-users of the application and with a running model of the application, The Ashvins Group developed a comprehensive Software Requirements Specification. From there, a Detailed Design Document was developed that included all existing functionality. Finally, the application was fully validated to provide sufficient documentation to support the continued use of the application in an FDA regulated environment. By creating “retrospective documentation” to support the application, the client was able to implement the existing software and use the software as a base-line to support continuing development efforts for the application.

VERIFICATION AND VALIDATION FOR "OFF THE SHELF" SOFTWARE APPLICATION

Client Profile: A leading global provider of laboratory instrument systems

Technologies Used: FDA Regulations/Standards, IEEE Documentation Standards, Computer Related Systems Validation (CRSV) Methods, Project Management Techniques

Project Summary: The instrument manufacturer was scheduled to release a new instrument that uses a third party “Off the Shelf” (OTS) software product to interface with a Laboratory Information System (LIS) and other laboratory instrumentation. The third party software had no record of validation.

U.S. FDA and ISO both require Software Validation and Verification. The GMP states "Design validation shall include software validation and risk analysis." All devices automated with software are subject to this regulation.

Working with the client, The Ashvins Group performed the Validation and Verification activities which included the creation of the following documentation: Validation and Verification plans, Hazard Analysis, Test Cases and the Validation and Verification Report. The Validation Plan provided a comprehensive listing of activities and their accompanying timeline. The Hazard Analysis consisted of a Failure Mode Effects Analysis (FMEA) and a Fault Tree Analysis (FTA). The FMEA was used to recognize and evaluate the potential failure modes and causes associated with the software application. The ultimate benefit of FMEA is cost savings. By focusing on potential failures or deficiencies and their causes before they occur, the savings are substantial. The FTA is a “top down” approach where a system or safety hazard is assumed. The FTA uses detailed logic diagrams, basic failures or simulated events to determine if the hazard could occur. Test cases were developed that elicited the behavior from the application and identified the expected results as specified in the requirements documentation.

The completed V & V Report provided an all-inclusive summation of all of the results and provided the final certification of the software’s performance and quality. In addition to the documentation, The Ashvins Group was responsible for the timely execution and monitoring of the test cases and results. Ashvins also worked closely with the third party original source of the OTS software. By applying proven Software Verification & Validation techniques, The Ashvins Group was successful in providing the V & V documentation necessary to support the use of the application in an FDA regulated environment which enabled the client to meet their aggressive time to market goal.

DEVELOPMENT OF A GLUCOSE DATA MANAGEMENT SYSTEM

Client Profile: A Medical Device Company seeking to provide improved software technology for blood glucose measurement and patient data management.

Technologies Used: Use Case Analysis, Borland CaliberRM, UML, Requirements Engineering, Borland Model Maker, knowledge of Clinical Diagnostics Device functionality and interfaces, Delphi, SQL, and Mercury Test Director.

Project Summary: The client needed to replace their existing product that manages patient blood glucose results with a state-of-the-art web enabled system in order to maintain their market leadership and provide their patients a system that efficiently tracks results and shares data with Healthcare Providers. A comprehensive software requirements specification (SRS) document is required to support system development. The SRS is the primary reference for the development of the application design and must contain an accurate and detailed description of system behavior. The SRS is also the primary source from which the Development Team produces a strategy for testing the end product. The development effort included a PC based client application and a backend database that communicate via Web interface in order to share data among subscribers while following HIPAA guidelines.

Working with the client, The Ashvins Group managed and directed the activities necessary to develop the application. These activities included many processes:

• Facilitated Use Case Analysis and Requirements Review Sessions. Clearly defined the requirements for the development of a multi-user intuitive application that includes a Windows based front end, with a web enabled back-end Host System. This application synchronizes data elements between the home user and the Healthcare Provider so that both have visibility to the same data. Data is uploaded directly from glucose-related medical devices to the Windows application to simplify data entry.

• Provided requirements that will ensure the application’s enhanced flexibility and scalability for current and future technology.

• Developed the application in a phased approach based on the Rational Unified Process.

• Prepared, executed, and directed the software verification.

• Prepared documentation based on FDA Guidelines for application development and validation for a Medical Devices.

The team based management approach incorporating both an Ashvins development team and a client project team greatly contributed to defining and developing an innovative, robust, and unique application.

SYSTEM VALIDATION AND IQ, OQ, AND PQ FOR LABORATORY AUTOMATION INSTRUMENTATION

Client Profile: A global specialty pharmaceutical company that develops and commercializes innovative drug and cosmetic products.

Technologies Used: Gemini software, VB.net, FDA Regulations/Standards, IEEE Documentation Standards, Computer Related Systems Validation (CRSV) Methods, Project Management Techniques.

Project Summary: The pharmaceutical client recently implemented the use of a TECAN Genesis system and components for the preparation of ELISA plates as part of their drug release assay. The Ashvins Group was contracted to lead the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) efforts for this important automation project. Installation Qualification is the process of demonstrating through documentation and verification that an instrument and all of its components have been installed correctly according to the manufacturer’s technical and/or configuration specifications. The Operational Qualification step then demonstrates that an instrument system and associated software function according to its specifications and requirements (including FDA regulations such as 21 CFR 11) in the selected environment. Afterwards, the Performance Qualification activities are designed to confirm that an instrument consistently performs according to the specifications appropriate for its routine use. This complete IQ/OQ/PQ process provides documented verification that the integrated system performs as specified in its normal operating environment; i.e., the TECAN Genesis system performs as intended.

Working with the client, The Ashvins Group prepared the IQ, OQ and PQ Validation Plan, executed on-site all of the IQ, OQ and PQ protocols and prepared the Summary of Results documentation. The client was able to capitalize on the Ashvins’ laboratory automation expertise, knowledge of FDA regulations and validation skills to efficiently document and implement their ELISA TECAN automation system into their manufacturing process.