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000-637 - Requirements Management with Use Cases - Part 2 - Dump Information

Vendor : IBM
Exam Code : 000-637
Exam Name : Requirements Management with Use Cases - Part 2
Questions and Answers : 111 Q & A
Updated On : December 18, 2018
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000-637 Questions and Answers

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000-637 Requirements Management with Use Cases - Part 2

Study Guide Prepared by Killexams.com IBM Dumps Experts


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000-637 exam Dumps Source : Requirements Management with Use Cases - Part 2

Test Code : 000-637
Test Name : Requirements Management with Use Cases - Part 2
Vendor Name : IBM
Q&A : 111 Real Questions

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IBM IBM Requirements Management with

IBM Takes purpose at Nutanix With Multicloud manager | killexams.com Real Questions and Pass4sure dumps

foreign company Machines(NYSE: IBM) has built an $18.5 billion cloud business by way of focusing on the needs of its shoppers. About 80% of mission-critical workloads and sensitive statistics nonetheless run on on-premises hardware as a result of efficiency or regulatory necessities, in response to Ovum. IBM's heavy center of attention on deepest cloud and hybrid cloud makes experience in that context.

a further statistic riding IBM's cloud method: eighty five% of companies are the use of a couple of cloud ambiance, in response to IBM's Institute for company cost. whereas Amazon net services and Microsoft Azure dominate the marketplace for public cloud infrastructure, many organizations are spreading workloads across distinctive public clouds and on-premises hardware, instead of going all in on a single public cloud. Managing these multi-cloud workloads can get complicated fast.

IBM's Global Center for Watson IoT in Munich, Germany.© IBM IBM's global middle for Watson IoT in Munich, Germany. A multi-cloud world

it really is the place IBM is available in. The business announced on Monday its Multicloud supervisor, a solution that makes it possible for valued clientele to control complex multi-cloud workloads. The gadget offers a dashboard interface for managing container-primarily based functions spread throughout diverse cloud environments, even those of IBM's opponents, as well as on-premises hardware.

The answer is optimized for IBM's cloud, however the enterprise notably mentioned assist for Amazon internet functions, Microsoft Azure, and crimson Hat's private cloud. "With its open source approach to managing facts and apps across distinctive clouds, the IBM Multicloud manager will allow companies to scale their many cloud investments and unleash the full company cost of the cloud," spoke of IBM Hybrid Cloud senior vice chairman Arvind Krishna within the press release saying the product.

while IBM claims that Multicloud manager is the "world's first multicloud administration technology," it really is now not completely correct. Managing workloads across diverse clouds is the bread and butter of Nutanix(NASDAQ: NTNX), a corporation that offers software that "melds inner most, public and allotted cloud working environments and offers a single element of control to manipulate IT infrastructure and applications at any scale."

Nutanix generated $1.sixteen billion of income in fiscal 2018, with most of that coming from application and assist, which grew by forty seven% in comparison to 2017. there is a big and turning out to be market for multi-cloud management, and IBM's Multicloud supervisor is the business's effort to seize a chunk of that pie.

IBM's key capabilities over Nutanix should be its giant trove of customer relationships. IBM counts as customers giant firms and governments, a few of which have been the use of IBM solutions for decades. As those groups tiptoe into the cloud, IBM's Multicloud manager will be smartly located to assist simplify the technique.

IBM's Multicloud Manager dashboard.© IBM IBM's Multicloud supervisor dashboard. company agnosticism

IBM has its personal public cloud, so why is the company helping Amazon, Microsoft, and other rivals with its Multicloud manager? because at its core, IBM is an organization that solves complications for its consumers. and often an IBM-most effective solution would not reduce it.

returned within the Nineteen Nineties, when outsider CEO Lou Gerstner was brought in to keep the enterprise from cave in, some of the pillars of the enterprise's turnaround was manufacturer agnosticism. Gerstner wanted IBM's capabilities company to be a one-cease shop in a position to building built-in solutions for its customers. however that required sometimes favoring opponents' products. Gerstner wrote in his book, Who Says Elephants can't Dance?:

To be really a success, we might have to do things that might shake the location to its roots. for example, the features unit would should be in a position to recommend the products of Microsoft, HP, solar, and all different essential IBM rivals if that, basically, changed into the superior solution for the customer. Of route, we might have to hold and service these items as well.

With Multicloud supervisor, that manufacturer-agnostic approach is terribly plenty alive and smartly at IBM. It won't assist IBM win public cloud market share from Amazon and Microsoft, but it surely will unencumber a turning out to be marketplace for multi-cloud management.

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Whirlpool signs IBM as cloud administration partner | killexams.com Real Questions and Pass4sure dumps

Whirlpool organization has grew to become to IBM to aid it control its bevy of global digital operations within the cloud.

The Benton Harbor-based appliance maker said last month it's going to use IBM Cloud “to control and provide 24/7 access to the business’s vital enterprise purposes,” including commercial enterprise aid planning, client relationship management and enterprise warehousing.

Whirlpool plans to leverage the “flexibility and scalability” of the IBM Cloud to run Whirlpool’s SAP HANA environments, including around-the-clock insights into its 70 global manufacturing websites, its distribution and make contact with facilities and a couple of other programs to deliver “worldwide entry and increased efficiencies.”

SAP HANA is a database administration gadget developed with the aid of Walldorf, Germany-primarily based SAP.

“Whirlpool corporation is a manufacturing chief, and we have moved our work to the cloud aggressively,” said Mike Berendsen, VP of IT, Whirlpool employer. “This collaboration with IBM will continue to enable us to leverage the capabilities of SAP on HANA, as we continue to be a tech-ahead company within the items we design and our international work environments.”

IBM currently added a new SAP-licensed managed applications providing for SAP HANA workloads. it's an built-in approach for hardware, utility and features, and the business observed it's the first to offer “this degree of cloud help” for workloads of up to 24 terabytes by using IBM vigor programs and IBM Storage. IBM referred to the method will provide “even the biggest shoppers” the skill they should control analytics in the cloud.

IBM talked about its innovation turned into “key” to gaining Whirlpool as a shopper, because the enterprise has enterprise necessities that pressure “very huge” HANA platforms exceeding “generally attainable” cloud capacities for HANA.

“The introduction of rising technologies has offered businesses like Whirlpool business enterprise with an entire new platform to innovate on,” spoke of Mark Slaga, international expertise features customary supervisor, IBM features for Managed purposes. “Prior solutions often lacked the skill to scale to meet the needs of customers like Whirlpool and required significant customization, which could force up prices.

“With this solution, we’re featuring Whirlpool employer the skill to scale its HANA atmosphere to keep up on method.”

below the brand new partnership, Whirlpool now has alternatives to expand its SAP HANA portfolio and “can center of attention on what’s most important to its company,” IBM observed.

Whirlpool

Whirlpool supplier (NYSE: WHR) is an appliance manufacturer with ninety two,000 employees and 70 manufacturing and expertise analysis facilities everywhere.

The company markets the manufacturers Whirlpool, KitchenAid, Maytag, Consul, Brastemp, Amana, Bauknecht, Jenn-Air, Indesit and other important brand names.

The company mentioned 2017 sales of $21 billion.

IBM capabilities

centered in 1995, IBM features is the professional services arm of Armonk, long island-primarily based IBM.

The division makes use of advanced know-how to support clients in the reduction of can charge and chance, achieve compliance, accelerate speed to market, create new income streams and establish a “security-prosperous and legit” infrastructure that’s in a position for AI and hybrid cloud.

It offers a number of functions: functions capabilities; company procedure, operations, resiliency, approach and design; cloud, digital office, community and safety services; and know-how support and consulting.


New statistics management options for intelligent Simulations | killexams.com Real Questions and Pass4sure dumps

The fashion in excessive performance supercomputer design has advanced – from proposing highest compute ability for advanced scalable science purposes, to capability computing employing effective, competitively priced computing vigour for fixing a small number of tremendous issues or a huge variety of small problems. The subsequent technology of supercomputers can be optimized for workflow computing, utilizing system utility and hardware infrastructure to time table and coordinate an ensemble of functions solving problems too advanced to even be modeled with a single utility. Whereas common HPC is dominated by batch scheduled jobs running to completion or failure, workflow computing requires frameworks that can be used to permit runtime interactions between applications and clients. IBM developed the IBM facts broking service [open sourced at github.com/IBM/data-broker] to facilitate the runtime alternate of facts between functions deployed in a workflow.

One rising category of workflow, is clever Simulation in which computing device learning suggestions are used to inform complex simulations to execute extra effectively and in the reduction of time to solution. IBM and Lawrence Livermore country wide Laboratory partnered to develop an intelligent simulation workflow to extra correctly schedule and execute multi-scale simulations of phone membrane fashions primary to getting to know RAS-initiated cancers.

As a part of this task, the IBM facts broker become deployed on the Sierra supercomputer at very huge scale and used to trade statistics between multi-scale simulations written in C and numerous laptop gaining knowledge of and analytics applications written in Python.  in the course of standing up this workflow, the groups developed a stronger understanding of bandwidth and latency necessities in creating an most reliable workflow solution at scale. As equipment screw ups are a fact in any giant scale cluster, the value of saving and restoring a stateful workflow is critical. historically, checkpoint/restart mechanisms had been critical to long operating simulations, but they are equally vital to stateful workflow computing options.

figure 1: File I/O versus records broker for Workflows statistics alternate

   figure 1 contrasts the IBM data broker approach with average Posix file I/O. youngsters file I/O can also be used to exchange facts at runtime, the lower latency and higher bandwidth requirements of a posh workflow including simulation and AI make the data broker answer a far better answer.

The IBM information broker became conceived with several fundamental design desires:

  • primary programming interface for purposes to make use of to place and get statistics from a allotted facts shop
  • Leverage an information shop that resided in memory, SSD, or hard disk and steer clear of the latency and bandwidth constraints of changing data in a workflow the use of Posix file I/O
  • guide for outlining and managing distinct namespaces
  • capable of leveraging each utility or hardware accelerated object stores
  • access throughout on premise and exterior systems including public clouds
  • figure 2: IBM statistics broking service structure

    determine 2 shows the excessive stage architecture of the statistics broker. The picture highlights a person library that offers that client API at present supporting both C/C++ and Python. moreover, a system library allows assist of distinctive backend key-cost outlets devoid of recompiling the utility. The existing version supports Redis and GasNet with prototyping of hardware accelerated backend.

    figure 3: IBM statistics broking service Namespaces

    applications, as shown in figure 3, use the client API to form connections with the backend key-cost store and create/spoil, connect/detach to namespaces shared by using one or more of the purposes in the workflow.  The functions use an easy key-value API to place/get records to/from the records broking service. The statistics broking service device library interfaces with the backend allotted key-value keep to locate the records throughout the dispensed statistics save. for example, when Redis is used as a data store, the proper hash slot is computed from a CRC16(key) modulo 216 . different backend statistics retailers may additionally use different algorithms to distribute keys. in any case, the IBM information broker abstracts the region of the hash slot and key from the application.

    The IBM statistics broking service remains in early building ranges and extra feature is being brought to deliver a higher store/restore gadget in addition to cut back latency of records exchanges. The preliminary work has been open sourced at github.com/IBM/information-broking service.

    talk over with IBM subsequent week at SC18 (sales space #3433) in Dallas, Texas, to learn about main-facet HPC and AI solutions. Register right here for technical briefings and consumer neighborhood classes.

    With contributions from Carlos Costa, Claudia Misale  and Lars Scheidenbach

    IBM Cognitive and Cloud options

    information Centric systems

    IBM T. J. Watson analysis


    000-637 Requirements Management with Use Cases - Part 2

    Study Guide Prepared by Killexams.com IBM Dumps Experts


    Killexams.com 000-637 Dumps and Real Questions

    100% Real Questions - Exam Pass Guarantee with High Marks - Just Memorize the Answers



    000-637 exam Dumps Source : Requirements Management with Use Cases - Part 2

    Test Code : 000-637
    Test Name : Requirements Management with Use Cases - Part 2
    Vendor Name : IBM
    Q&A : 111 Real Questions

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    Requirements Management with Use Cases - Part 2

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    Oracle Cloud Unveils New HPC Offerings to Support Mission Critical Workloads | killexams.com real questions and Pass4sure dumps

    Oracle now provides a complete set of solutions for any high performance computing workload, built to offer the best performance at the lowest cost in the cloud

    REDWOOD SHORES, Calif., Nov. 12, 2018 /PRNewswire/ -- Oracle today announced availability of new bare metal Oracle Cloud Infrastructure compute instances to help enterprises run various performance sensitive workloads, such as artificial intelligence (AI) or engineering simulations, in the cloud. These new instances are part of Oracle's new "Clustered Network," which gives customers access to a low latency and high bandwidth RDMA network. Oracle now provides large organizations with a complete set of solutions for any high performance computing (HPC) workload, enabling businesses to capitalize on the benefits of modern cloud computing while enjoying performance comparable to on-premises compute clusters at a cost that makes sense for their businesses. 

    Oracle Logo (PRNewsfoto/Oracle)

    More

    Countless enterprises have considered a transition to the cloud for years for their legacy HPC workloads, but were unable to do so due to the lack of high performant cloud offerings or economics that would make it too expensive to run in the cloud. Organizations have struggled to find a cloud that can support new workload requirements while realizing cost efficiencies and flexibility that meet business goals and overall technology vision. With today's news, organizations finally have a low-cost path to extend their on-premises HPC workloads to the cloud without sacrificing performance.

    "HPC has been underserved in the cloud due to lack of high performance networking (RDMA) and unappealing price/performance. We've listened to our customers and over the last few years Oracle has focused on improving high performance bare-metal offerings, such as Clustered Networking, to provide on-premise customers with the options they need to extend their HPC workloads to the cloud," said Vinay Kumar, vice president, Product Management & Strategy, Oracle Cloud Infrastructure. "Our growing collaboration with trusted vendors helps Oracle Cloud Infrastructure continue to expand and offer the best performance at the lowest cost for the workloads that customers really need to extend into the cloud."

    With Oracle's Clustered Network offering at the data center level, Oracle has opened up an entirely new set of use-cases and workloads that enterprises can harness the power of cloud computing for, ranging from car crash simulations in automotive and DNA sequencing in healthcare to reservoir simulation for oil exploration. Organizations can now deploy additional use-cases previously out of their reach, such as using data from their Oracle Database and cutting-edge NVIDIA(R) Tesla(R) GPUs to run Neural Network AI training and instantly adding value to their data.

    The new offering is powered by high-frequency Intel® Xeon® Scalable processors and Mellanox's high performance network interface controllers. For more than 25 years, Oracle and Intel have worked closely to bring innovative, scalable, and secure enterprise-class solutions to its customers. This new addition completes Oracle's comprehensive set of infrastructure solutions for the full range of both CPU- and NVIDIA GPU-based HPC workloads, providing customers with streamlined and lower cost access to specialized offerings in the cloud. Oracle Cloud Infrastructure now provides a complete range of HPC workloads, including the only bare metal Infrastructure-as-a-Service (IaaS) offering on the market with RDMA.

    Story Continues

    These new HPC instances with Clustered Networking are offered across Oracle regions in the US and EU at $0.075 per core hour, a 49 percent pay-as-you-go savings compared to other cloud providers on the market.

    Additionally, these capabilities will also be expanded for Oracle's recently announced support for NVIDIA HGX-2 platform on Oracle Cloud Infrastructure. Customers will be able to take advantage of clustered networking as part of the next generation of NVIDIA Tensor Core GPUs, opening up large scale GPU workloads such as AI and deep learning.

    Industry Quotes

    "HPC is critical for more use cases, complex workloads, and data-intensive computing than ever before. Access to HPC capabilities in the cloud enables users to do more by extending into the public cloud while providing new HPC and AI users a platform to develop and test new classes of HPC and AI algorithms," said Lisa Davis, vice president of Intel's Data Center Group and General Manager of Digital Transformation and Scale Solutions. "We are working with Oracle to enable leading HPC offerings that take advantage of the advanced performance, efficiency and scale delivered by Intel® Xeon® Scalable processors across HPC and AI workloads, all while benefiting from the agility and flexibility of Oracle's next generation, enterprise-grade cloud offering."

    "As organizations look to ensure they stay ahead of the competition, they are looking for more efficient services to enable higher performing workloads. This requires fast data communication between CPUs, GPUs and storage, in the cloud," said Michael Kagan, CTO, Mellanox Technologies. "Over the past 10 years we have provided advanced RDMA enabled networking solutions to Oracle for a variety of its products and are pleased to extend this to Oracle Cloud Infrastructure to help maximize performance and efficiency in the cloud."

    "With the massive explosion of data, you need larger clusters of GPUs to process and train the data being produced. HGX-2 on Oracle is the perfect fit for this problem," said Ian Buck, vice president of Accelerated Computing, NVIDIA. "HGX-2 on Oracle combines cutting-edge V100 Tensor Core GPUs and NVSwitch along with ability to scale across multiple HGX-2s using Clustered Networking to solve the biggest computing challenges."

    Supporting Resources

    About Oracle Cloud Infrastructure Oracle Cloud Infrastructure is an enterprise Infrastructure as a Service (IaaS) platform. Companies of all sizes rely on Oracle Cloud to run enterprise and cloud native applications with mission-critical performance and core-to-edge security. By running both traditional and new workloads on a comprehensive cloud that includes compute, storage, networking, database, and containers, Oracle Cloud Infrastructure can dramatically increase operational efficiency and lower total cost of ownership. For more information, visit https://cloud.oracle.com/iaas. 

    About OracleThe Oracle Cloud offers complete SaaS application suites for ERP, HCM and CX, plus best-in-class database Platform as a Service (PaaS) and Infrastructure as a Service (IaaS) from data centers throughout the Americas, Europe and Asia. For more information about Oracle (ORCL), please visit us at www.oracle.com.

    TrademarksOracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

    Future Product DisclaimerThe preceding is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, timing, and pricing of any features or functionality described for Oracle's products may change and remains at the sole discretion of Oracle Corporation.

     

    View original content to download multimedia:http://www.prnewswire.com/news-releases/oracle-cloud-unveils-new-hpc-offerings-to-support-mission-critical-workloads-300747806.html


    New Data Management Techniques for Intelligent Simulations | killexams.com real questions and Pass4sure dumps

    The trend in high performance supercomputer design has evolved – from providing maximum compute capability for complex scalable science applications, to capacity computing utilizing efficient, cost-effective computing power for solving a small number of large problems or a large number of small problems. The next generation of supercomputers will be optimized for workflow computing, utilizing system software and hardware infrastructure to schedule and coordinate an ensemble of applications solving problems too complex to even be modeled with a single application. Whereas traditional HPC is dominated by batch scheduled jobs running to completion or failure, workflow computing requires frameworks that can be used to enable runtime interactions between applications and users. IBM developed the IBM Data Broker [open sourced at github.com/IBM/data-broker] to facilitate the runtime exchange of data between applications deployed in a workflow.

    One emerging type of workflow, is Intelligent Simulation in which machine learning techniques are used to inform complex simulations to execute more efficiently and reduce time to solution. IBM and Lawrence Livermore National Laboratory partnered to develop an intelligent simulation workflow to more efficiently schedule and execute multi-scale simulations of cell membrane models relevant to studying RAS-initiated cancers.

    As part of this project, the IBM Data Broker was deployed on the Sierra supercomputer at very large scale and used to exchange data between multi-scale simulations written in C and multiple machine learning and analytics applications written in Python.  In the course of standing up this workflow, the teams developed a better understanding of bandwidth and latency requirements in creating an optimal workflow solution at scale. As system failures are a reality in any large scale cluster, the importance of saving and restoring a stateful workflow is critical. Traditionally, checkpoint/restart mechanisms were important to long running simulations, but they are equally important to stateful workflow computing solutions.

    Figure 1: File I/O versus Data Broker for Workflows Data Exchange

       Figure 1 contrasts the IBM Data Broker approach with traditional Posix file I/O. Although file I/O can be used to exchange data at runtime, the lower latency and higher bandwidth requirements of a complex workflow including simulation and AI make the Data Broker solution a better solution.

    The IBM Data Broker was conceived with several fundamental design goals:

  • Simple programming interface for applications to use to put and get data from a distributed data store
  • Leverage a data store that resided in memory, SSD, or hard disk and avoid the latency and bandwidth constraints of exchanging data in a workflow using Posix file I/O
  • Support for defining and managing multiple namespaces
  • Capable of leveraging both software or hardware accelerated object stores
  • Access across on premise and external systems including public clouds
  • Figure 2: IBM Data Broker Architecture

    Figure 2 shows the high level architecture of the Data Broker. The picture highlights a user library that provides that client API currently supporting both C/C++ and Python. In addition, a system library enables support of different backend key-value stores without recompiling the application. The current version supports Redis and GasNet with prototyping of hardware accelerated backend.

    Figure 3: IBM Data Broker Namespaces

    Applications, as shown in Figure 3, use the client API to form connections with the backend key-value store and create/destroy, attach/detach to namespaces shared by one or more of the applications in the workflow.  The applications use a simple key-value API to put/get data to/from the Data Broker. The Data Broker system library interfaces with the backend distributed key-value store to locate the data across the distributed data store. For example, when Redis is used as a data store, the correct hash slot is computed from a CRC16(key) modulo 216 . Other backend data stores may use different algorithms to distribute keys. In any case, the IBM Data Broker abstracts the location of the hash slot and key from the application.

    The IBM Data Broker is still in early development stages and additional function is being added to provide a more robust save/restore system as well as reduce latency of data exchanges. The initial work has been open sourced at github.com/IBM/data-broker.

    Visit IBM next week at SC18 (booth #3433) in Dallas, Texas, to learn about leading-edge HPC and AI solutions. Register here for technical briefings and user group sessions.

    With contributions from Carlos Costa, Claudia Misale  and Lars Scheidenbach

    IBM Cognitive and Cloud Solutions

    Data Centric Systems

    IBM T. J. Watson Research


    A Better Approach To Pharmaceutical Water Testing — User Requirements For An Online Water Bioburden Analyzer | killexams.com real questions and Pass4sure dumps

    By Online Water Bioburden Analyzer Workgroup

    Pharmaceutical water testing is comprised of several components; among which are appearance, total organic carbon, conductivity, bioburden, and endotoxin testing to ensure product quality and patient safety. Currently, conductivity and total organic carbon (TOC) are the only attributes routinely performed with online testing.

    Bioburden and endotoxin testing traditionally have been performed retrospectively, and only through sufficient validation and historical data is sufficient confidence developed. Online water bioburden analyzers (OWBAs) have the potential to eliminate sampling and testing errors via reduced manipulations, while providing increased product safety and process control by making statistically significant real-time data available.

    Online monitoring provides early warning of system upsets and provides process engineers and quality groups the ability to ensure the water used for manufacturing is of sufficient quality prior to use.

    The OWBA must have the capability and flexibility to be used for purified water (PW), water for injection (WFI), cleaning verification, etc.

    The prescribed limits of 100 colony forming unit (CFU)/mL for PW and 10 CFU/100 mL (0.1 CFU/mL) for WFI are arbitrary values used to measure the bioburden levels of water quality. Current water monitoring, composed of daily samples, provides only snapshots for identifying changes in water system stability and therefore cannot be reliably used for meaningful trending analysis. The EU monograph for WFI requires a minimum of 200 mL volume samples for testing.

    The challenge of developing a new measurement technology is the measurement unit. Due to the historical, regulatory, and legal significance of the terms CFU, total viable count (TVC), and cell, an alternate unit that does not limit technology development needed to be identified. The OWBA Workgroup has suggested the term auto-fluorescence unit (AFU) as a new unit to enable a unified approach to understanding and discussing the measurement system. However, other technologies that determine microbe equivalents can also be acceptable. Current OWBA technologies in development rely on fluorescence. The concept of microbe equivalents therefore may also be expressed in auto-fluorescence units (AFUs).

    The development of the OBWA provides the ability to monitor low-level microbial content. The OWBA ideally will measure at the compendial levels. Regardless, the system needs to provide a stable baseline used to ensure process control. Furthermore, the OWBA could be used to demonstrate the health and suitability of water systems.

    USP <1231> Pharmaceutical Water Testing Requirements

    The U.S. Pharmacopeia requires that water used for pharmaceutical purposes meet the following specifications.

    Table 1: Specifications for Water Purity

    Online Water Bioburden Analyzer User Requirement Specifications (URS)

    The following sections outline the minimum user requirements for an OWBA as specified by the OWBA Workgroup.

    Bioburden I Microorganism Testing

  • Limit of Detection (LOD): 1 AFU / mL
  • Limit of Quantitation (LOQ): 10 AFU / mL (proportional to 10CFU/100mL)
  • Limit of Linearity: 10,000 AFU / mL
  • Range: 1 to 10,000 AFU / mL
  • Note: The current WFI microbial requirement is NMT 10 CFU/100 mL. The acceptance level would be determined based on the technology and would not necessarily be expressed as colony-forming units. (LOD, LOQ, and range may be demonstrated through stable baseline analysis of signal-to-noise ratios.)

    Calibration

  • Precision: <50% at LOQ 1 AFU and <25% at 5 LOQs AFU
  • Accuracy: ± 30% of measurement of 6 replicates at 5 LOQs AFU
  • pH Range: 4.0 to 8.0
  • Analysis Modes:
  • Online (continuous) or
  • Periodic testing frequency (e.g. circa one sample every 4 minutes)
  • Daily (once per day at designated time)
  • System Suitability - Desirable Attributes

    The analyzer should be capable of performing periodic verification of operational performance. Suitability standards should represent the potential contamination or artificial spikes. The suitability standard should be a surrogate for microbial contamination. The use of live or killed microorganisms is not acceptable.

  • Ozone Compatibility: Maximum 300 ppb as 03
  • External Flow Rate (line or sample flow rate): Maximum 50 mL/min
  • System Supply /Temperature Range: 10°  to 95° C, although the sample will be transmitted in non-insulated lines
  • Sample Pressure: Up to 100 psig with spikes to 150 psig. (e.g., water hammer magnitude)
  • Potential Interferences: System provides robust analyses even in the presence of reasonable amounts of residual sanitizer, rouge, gasket particulates, and particulate up to 25 µm
  • Calibration Stability: Source I detector stable for six months
  • Display Readout: Three significant digits with trending plot of at least 4 hours data
  • The unit should be designed to prevent reverse flow.
  • Instrument

  • Power: 100-260 VAC, 50/60 Hz
  • Installation I Overvoltage
  • Category II (protects against transients present in Category II power)
  • Safety Certifications: UL/cUL and CE
  • Normal Operating Environment:
  • Ambient Temperature: 2° to 40° C (35° to 104° F)
  • Maximum Relative Humidity: Up to 95%, non-condensing
  • Maximum Altitude: 2000 m (6500 ft)
  • IP Rating: Environmental IP 35 or NEMA equivalent
  • Equipment can be sanitized with caustics, free of crevices, manufactured from non-shedding, non-corroding materials
  • Inputs: At least one isolated binary input
  • Outputs:
  • At least one isolated 4-20mA output,
  • 10-100 Mb Ethernet,
  • one USB 2.0 port, and
  • one alarm output
  • Communications Protocol:
  • 802.11 a/b/g/n WiFi Capability
  • Interface scripts for Plant Distributed Control System (e.g. Delta V)
  • Fully CFR 21 part 11 compliant (data records, audit trails, user rights assignment, etc.)
  • LIMS connectivity, bidirectional capability to provide input I output.
  • Display: Backlit Quarter-VGA touchscreen display
  • Consumables To Be Supplied With Original Purchase Order (System May Use Reagents If Needed)

  • Consumable reserves for 90 days operation
  • Reagents sufficient for 45 days of unattended operation
  • Suitable temperature storage for reagents
  • Low reagent alarms
  • Supplier agreement for spare parts / consumables
  • 1 year of operation (may be held at vendor with 24-hour availability based on company practices)
  • 60-day notification of supplier change for spare parts / consumables
  • Additional Design Considerations (Points To Consider For The System)

  • System pipework, connections, and internal flow paths should be of sanitary design able to be routinely sanitized, in accordance with ISPE good practice guidance
  • Vibration tolerant
  • Capable of excursion sample collection (filtration, IV bag, or sample bottle) or of sending a signal that could be used to trigger a sample collector
  • Self-sanitizing or simple method to sanitize fluid path
  • Two modes of use:
  • Bench-top portability — ability for unit to be moved to individual points of use or used on a bench top
  • Internal power for portable operation or potential battery cart with system for 120 minutes operation
  • System may have manifolds or multiplex capability to monitor several points simultaneously
  • Customer Requirement Considerations (Points To Consider For System Design And Support)

    Potential customers for a device that uses alternative methodologies have defined expectations that must be satisfied in order to have the device accepted by a regulatory authority. These requirements are broadly outlined below for the benefit and insight of instrument developers and vendors. For further information, consult PDA Technical Report 33, USP <1223>, and EU 5.1.6.

    USP <1223> User Requirements

    Determining the precise technical requirements necessary for an alternative microbiological method is essential before one can select the appropriate technology and equipment that meet the relevant assay requirements. Therefore, it is suggested that organizations wishing to develop and validate a candidate alternative method produce a user requirement specification (URS) document. This document should include all critical functions of the technology, critical user interface requirements, space requirements, environmental requirements, operational requirements, and all other important characteristics of an alternative method for the intended use. These requirements will be specific to the company or organization, as well as to the alternative method's intended use, and therefore the requirements should be generated by the user.

    In generating the URS document, three separate components of the alternative microbiological method validation must be considered:

    1. Instrument qualification. Most alternative microbiological methods will depend on specific equipment. This analytical equipment is subject to industry standard instrument qualification requirements (see USP <1058> for further information).

    2. Validation of alternate technologies. The basic rationale for using an alternative methodology is to improve on some aspect of the existing technology of the current compendial method without sacrificing essential characteristics of that technology (e.g., plate count and membrane filtration). The current technology for compendial microbiology methods consists of detection of the growth of viable microorganisms on (or in) a nutrient medium. The alternative technology must be at least equivalent to the current technology in terms of performance for the intended use. Much of the technical support for equivalence may come from the peer-reviewed scientific literature or from a prior regulatory submission (e.g., a vendor submitted the Drug Master File to the FDA, or prior submission from a company on this technology), but this must be confirmed, as appropriate for the intended use.

    Method suitability. This consideration must address both the technology's suitability to the specific test and the lack of product inhibition and enhancement on the test results.

    a. Suitability of the technology to the specific test. Many compendial microbiological tests have mandated test requirements. An example of this would be sample plans consisting of the quantity of material to be tested (e.g., 10 g or 20 units of a specific volume). Because the test results are frequently used to determine compliance with finished product specifications, and the specifications are dependent on sample volume or quantity, the alternative technology must be able to satisfy sample volume requirements as required in the general test method. The use of a lesser volume or sample size is not recommended and would need to be fully justified by the user on a case-by-case basis. The alternative technology is considered suitable if it can meet all critical parameters of the compendial test.

    b. Inhibition and enhancement. Specific products may interfere or enhance the signal of different measurement technologies to the specific signal of interest (see USP <1227>). This component of alternative microbiological method validation (i.e., suitability) must be demonstrated for each product tested.

    Summary

    These requirements were developed by the Online Water Bioburden Analyzer Workgroup to describe the characteristics of the technology/method required by end-user for routine water sample testing. This group recognizes that methods based on the colony-forming unit are unlikely to achieve continuous and real-time detection of viable microorganism from water systems. Alternative microbial detection methods such as those based on fluorescent biomarkers have the possibility of achieving continuous and real-time detection; therefore the group identified critical performance characteristics that are minimally required to meet the end-users’ needs. These characteristics, such as validation parameters for bioburden testing, calibration, system suitability, instrument operation, and data laboratory information management system (LIMS) interface have been assembled into this URS document. Additional system design features to be considered by technology/method developers are also included.

    Note: This document provides a design specification for a potential water analyzer; but is not to be considered an endorsement, support or purchase agreement with any vendor or the authors.

    An earlier URS version was published by members of this group in 2013 (“Novel Concept for Online Water Bioburden Analysis: Key Considerations, Applications, and Business Benefits for Microbiological Risk Reduction,” Anthony Cundell, Oliver Gordon, Nick Haycocks, Joe Johnston, Michelle Luebke, Neil Lewis, Jeanne Mateffy, and Jeffrey W. Weber, American Pharmaceutical Review. July 2015.) and served as a starting point for this updated and refined set of performance characteristics to be considered by the end-users and technology/method developers.



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    VCE [6 Certification Exam(s) ]
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    Vmware [58 Certification Exam(s) ]
    Wonderlic [2 Certification Exam(s) ]
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    Zend [6 Certification Exam(s) ]





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    IBM 000-637 Exam (Requirements Management with Use Cases - Part 2) Detailed Information



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