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Current Trends in Biotechnology and Pharmacy Vol. 5 (3) 1353-1361 July 2011, ISSN 0973-8916 (Print), 2230-7303 (Online) 1359 and for generating performance reports. The solution presents a single view of the total infrastructure of CRO i.e. single view of system, network and applications metrics. Client automation enterprise (CAE) : Client Automation Enterprise (3) has been implemented to collect the hardware and software inventory details of each desktop in the CRO besides distributing software simultaneously to all these desktops from centrally located server. By deploying this tool, the CRO will derive the following benefits. 1. Monitoring the application usage pattern on individual desktops and hence helps to strategize the application distribution across the desktops. 2. Monitoring and managing the licenses installed on each desktop. 3. To have a homogenous baseline desktop environment. 4. To keep all desktops in synchronization with latest software releases from application or Operating Systems (OS) specific vendors. HP TRIM (Transparent Records & Information Management) document management system, shown in (Fig 3), is a transparent records and information management system that can capture, share and manage information by applying automated rules, classifications and workflows. It adheres to ISO 15489 quality standards and complies with US FDA (Federal Drug Agency) 21 CFR Part 11 guidelines (2). TRIM document solution implemented at the Labs under study addresses the above problems besides replacing the current document management with a leading edge solution from HP. All the existing data and customization has been exported to TRIM using tools and techniques provided by HP. HP TRIM depends on Lightweight Directory Access Protocol (LDAP) for user authentication and it minimizes the cost impact by alleviating the earlier licensing requirements. Scientific applications: A clinical trial is sponsored by an organization and various organization roles are involved in conducting the Content management : The CRO has been using Lotus Domino document manger for managing documents and its workflows. However, it has been decided to phase out the existing Domino Document Manager because of the following reasons. 1. It has reached end of life with no support from IBM which is a major concern for some organization like Vimta. 2. It does not meet specific regulatory requirements such as 21 Code for Federal Regulation (CFR) Part 11. 3. It has performance problems due to resource constraints. 4. Growing licensing requirements because of tight integration with Lotus mail. Fig 3. TRIM high level view Information Technology Consolidation with Virtualization
Current Trends in Biotechnology and Pharmacy Vol. 5 (3) 1353-1361 July 2011, ISSN 0973-8916 (Print), 2230-7303 (Online) 1360 trial process. The CRO’s role under study in trial process is Contract Research and Testing Organization (CRTO) and site management. Each role has different service requirements which are met by various scientific applications that the organization has deployed at its data center. The major applications in the laboratory are described below. Laboratory Information Management System (LIMS) : LIMS is a full-featured client-server application on Microsoft Windows that meets all Good Laboratory Practices (GLP) requirements by providing full sample tracking, user certification, instrument management, standard and reagent management, full auditing, report and sample scheduling, on-line help, and many other functions. LIMS was designed to conform to the laboratories environment through configuration; not by custom programming. While most customers’ needs are met by off the shelf LIMS product, there are times that extensions to the system are desirable. To meet these extensions, LIMS open architecture allows configuration changes and customization using basics (4). Empower: Empower 2 is Waters’ flagship chromatography data software (CDS) package for advanced data acquisition, management, processing, reporting and distribution. Designed for a data-secured regulatory lab environment, Empower 2 will help labs to perform more efficiently and securely (4). It can help: • Store and retrieve chromatography data using an embedded, relational database. • Calculate more precise peak integrations with ApexTrack algorithm. . • Achieve more enhanced detection capabilities when using Waters mass detectors or the Waters Photodiode Array (PDA) detector • Grow seamlessly from a single workstation to an enterprise-wide system with Empower 2’s scalable, modular architecture SDMS: SDMS is a Scientific Data Management System (SDMS) is used to create a common electronic repository for all types of scientific data in the lab environment. SDMS allows the scientist in the lab to focus on the core work by eliminating the burden of paper work. SDMS improves the value of information by enabling scientist to share and utilize the data generated from a range of laboratory applications. The workflow in SDMS ensures that the documents can be viewed by analysts, group leader, quality control (QC) and QA to review and approve on time. SDMS is used for Project Management and storage and retrieval of instrumental and noninstrumental data with compliance to 21CFR Part11 of USFDA (4). Analysis: (Fig 4, Fig 5) are drawn using the data collected from two different implementations i.e. old and new database servers. The old database server is hosted on IBM AIX version 5.3. From figure 4, it is obvious Fig. 4. CPU and memory utilization of the old database server Chavali et al
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Page 175: (December 7-9, 2011) Venue: Karunya
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