Building the Agrochemical Regulatory Compliance Pipleine with Astrix

Chapter 5 Building the Agrochemical Regulatory Compliance Pipleine with Astrix e-Compliance Architecture

Downloaded by RUTGERS UNIV on December 31, 2017 | http://pubs.acs.org Publication Date: August 1, 2002 | doi: 10.1021/bk-2002-0824.ch005

Richard P. Albert Astrix Software Technology, Inc., 175 May Street, Suite 302, Edison, NJ 08837

The use of web-centric information technology systems will allow life science companies to bring their products to market faster, more efficiently and, ultimately, more safely. The process of registering a new drug or pesticide with the regulatory authorities is a long and data intensive process with numerous stakeholders. Pharmaceutical and Agrochemical companies are global organizations and the trials necessary to support product registration produce a vast amount of data.

Overview Each participant throughout the process and across the enterprise has individual informational needs which change on a regular basis and need to be shared and disseminated throughout the organization. Astrix has developed a strategy that allows global life science companies to comply with the regulatory

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© 2002 American Chemical Society

Garner et al.; Capturing and Reporting Electronic Data ACS Symposium Series; American Chemical Society: Washington, DC, 2002.

29 requirements using a web-centric information technology system (e-compliance system).


Characteristics of the Agrochemical Registration Process The Agrochemical registration process is composed of multiple steps that are interdependent. The integrity and timeliness of the completion of the entire process is dependent on successfully executing each of the steps. The process involves participants that are located at remote sites throughout the world. Many of the participants are third party contractors that also play a vital role in collecting data to support the regulatory approval process. Some common characteristics found in the agrochemical registration process include: • • • • • • • •

Deciding on new formulations, expanding product labels, and determining the company sales and marketing initiatives are essential business that have many participants. Study worksheets, bid-sheets, and laboratory andfieldprotocols are developed, reviewed and approved by various participants Thefieldpart of the study is dependent on the agrochemical practices of the remotefieldsite. Therefore, review and input by the remote site is essential. The laboratory must have access to methodologies, method validation information, and compound specific information. Datafrommultiple sources are sent to the sponsorfrommany participants, both internal and external. Many people, includingfieldcoordinators, lab managers, study directors, quality assurance personnel, farm managers, and others, are involved in the process. The generation of quality data that are complete, legible, traceable, and meet the requirements of the regulations is essential. The regulatory agency is the ultimate client and the generation of an electronic deliverable with essential information organized for easy evaluation and review is critical.

The agrochemical registration process involves many partners that must work together to reach the ultimate goal of adequately and efficiently reviewing an EPA regulatory submission. The sponsor,fieldcontractors, analytical laboratories, and the regulatory agency are all primary stakeholders in the process (See Figure 1).



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Figure 1. Partner Participation.

Astrix Agrochemical e-Compliance System Astrix Software Technology is building the next generation agrochemical management system to allow companies to manage the entire regulatory process via the corporate intranet. The system will allow authorized users to collaborate on the development of new ideas, generate worksheets and bid sheets, develop protocols, generate sample labels, web forms for the field, analytical reporting forms, and provide sample tracking, management, and financial data. The agrochemical e-compliance server is designed to allow multiple people to develop, review, and authorize documentation and data used in the registration process. The system operates by using the corporate intranet/extranet as the communication backbone for the system.

Astrix Agrochemical Ε-Compliance Architecture The technical architecture of the agrochemical e-compliance server is built around the premise of flexibility and scalability. The system is designed in three tiers (Figure 2). The components that comprise the architecture include agrochemical e-compliance interface, middle tier Astrix Ag COM components including middle tier reporting objects, and the Astrix Agrochemical database. The system components reside on a Windows NT server:


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Presentation Tier (User Interface) The presentation layer resides on a Windows NT Server running Microsoft Internet Information Server (IIS). All screens (forms) and reports are displayed in a web browser.


Business Logic Tier (Astrix Ag COM Components) The application layer resides on a Windows NT Server running Microsoft Transaction Server (MTS). All business logic is encapsulated in objects.

Data Tier (Agrochemical Database) The database layer resides on a Windows NT Server running an installation of Oracle 8 Enterprise Server Database.

Figure 2. Agrochemical e-Compliance Server Architecture.

The primary advantage of a web-centric architecture is that all business logic, data, and system functionality are maintained centrally on a web server. The system is a "zero footprint" architecture, meaning that no components are installed on the client. This eliminates conflicts with client operating systems, dynamic link library incompatibilities and a host of other problems resulting from software installation. The system can also be updated centrally without Garner et al.; Capturing and Reporting Electronic Data ACS Symposium Series; American Chemical Society: Washington, DC, 2002.

32 users needing to perform an upgrade. The data are stored behind afirewallin a secure Oracle 8 repository. Central data storage is the key security feature of the system.


Astrix e-Compliance Project Planning Module The regulatory study process originates with a new idea. New ideas can originatefrommany different sources in the organization and generally consist of new market opportunities for a product, such as, adding a new crop to a label or developing a new formulation. Typically, a preliminary project plan will be developed that includes a project timeline and estimated development costs. The database serves as a repository for vital information that allows the stakeholders to access, mine and evaluate data. A viability review can be conducted on line to evaluate the strategic fit, analyzefinancialinformation, and determine what data are needed to support the idea. If the results of the evaluation support the idea, it will move to the Assessment Phase. Input on the proposed project will be requested from the various functional groups to supplement the informationfromthe review phase. A Preliminary Project Plan is developed on line that includes a project timeline and estimated development costs.

Astrix e-Compliance Protocol Module Once the project has been approved it enters the protocol development process. The first step in the process is the completion of the protocol worksheets. The system allows users to create dynamic worksheets and bid sheets that can be automatically sent to contractors and collaborators. The draft protocols are developed from the information contained in the worksheets. Both the field and laboratory protocols are developed by various participants, usually Study Directors, and can be distributed via the corporate intranet for peer review.

Astrix e-FieldNotes System The protocol information can be assessed via a web browser by the field contractor. The observational in-life data can be entered on a standard desktop PC directly via an extranet connection to the server. Data that must be collected in the field (i.e., application data) can be collected with a Palm OS


33 based unit (i.e., Palm Pilot) and entered directly in the field. At the end of the day the Palm unit can be synchronized with the web server database. This architecture provides the user with the ultimate mobility and results in a high level of data security. The e-FieldNotes System is designed using the Wireless Application Protocol Technology (WAP) that is optimized for low bandwidth environments that are typically found in rural locations.


Astrix e-Laboratory System Astrix supports a standard data exchange file format that can be automatically generated either by the instrument data system (i.e., ChemStation, TurboChrom) or by a commercially available LIMS (i.e., PE LIMS) system. In addition, the laboratory can assess web-based forms and manually enter the analytical results directly into the server database. The system also supports custom generated reports and queries.

Astrix e-Report Module The final report system allows a user located anywhere in the world to access data from the Agrochemical repository database and generate reports. Depending on user access and security levels the user can generate the protocol and field, laboratory orfinaldata reports. In addition to data reports the system generates management summaries including both financial and resource allocation reports.

Summary Astrix Software Technology is a leading supplier of e-compliance tools to the environmental, pharmaceutical, medical device, and agrochemical industries. Web-centric computer systems allow data to be collected and accessed remotely while maintaining central control of the data and the application components. The corporate intranet brings customers, regulators, collaborators, and employees together. As life science companies continue to consolidate to face the challenges of a global marketplace the information technology providers must respond to this changing landscape. A global strategy for Agrochemical research and development must be supported with a system that extends throughout the enterprise and into every corner of the world.


Building the Agrochemical Regulatory Compliance Pipleine with Astrix

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