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EMC E20-593 : Backup and Recovery Implementation Exam

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Test Number : E20-593
Test Name : Backup and Recovery Implementation
Vendor Name : EMC
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E20-593 test Format | E20-593 Course Contents | E20-593 Course Outline | E20-593 test Syllabus | E20-593 test Objectives

Exam Title : Dell EMC Certified Specialist - Implementation Engineer - NetWorker (DECS-IE)
Exam ID : E20-593
Exam Duration : 90 mins
Questions in test : 60
Passing Score : 63%
Exam Center : Pearson VUE
Real Questions : Dell EMC NetWorker Specialist Real Questions
VCE practice questions : Dell EMC E20-593 Certification VCE Practice Test

Dell EMC NetWorker Overview 10%
- Describe a NetWorker solution and its advantages
- Identify and describe the NetWorker software components and their roles, data protection functions, and terminology
- Explain the use of NetWorker control data and administrative interfaces

Dell EMC NetWorker Modules Overview 15%
- Explain how NetWorker modules work with native applications to support backup and recovery
- Explain the backup and recovery process with NetWorker modules
- Explain the functionality of various NetWorker modules; for example, NMM and NMDA

Dell EMC NetWorker Installation and Configuration 40%
- Describe the NetWorker architecture and components, including processes and backup data flow
- Identify and describe how NetWorker and NetWorker Management Console are installed and licensed
- Identify and describe how to configure NetWorker backups; including client, protection group, policy and directive resources, and client save set and backup command attributes
- Explain the NetWorker backup options; including synthetic full backup, block based backup, snapshot management, and VMware backup options
- Identify and describe the features of NetWorker backup devices and how they are configured and managed; including device types, media pools, client direct backups, cloning, and staging

Dell EMC NetWorker Administration and Management 25%
- Identify and describe the NetWorker security features; including NetWorker authentication (AuthC), NetWorker user groups, logs, and configuring firewalls
- Identify and describe how the NetWorker server and NetWorker Management Console are configured and managed; for example: notifications, reports, parallelism, multi-tenancy
- Identify and describe how to recover Windows hosts and configure NetWorker in cluster environments
- Identify and describe how NetWorker recoveries are performed; for example: directed, browsable, and save set
- Describe the management and backup and recovery of NetWorker databases; for example: media and resource databases and client file indexes

Dell EMC NetWorker Cloud Enablement 10%
- Describe the NetWorker features and capabilities that support backup to and in the Cloud
- Describe how to "configure" NetWorker with CloudBoost and Cloud Tier
- Describe how to "manage" NetWorker with CloudBoost and Cloud Tier
- Describe the features and capabilities provide by the NetWorker vRealize Data Protection Extension

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EMC Practice Test

Design for Regulatory Compliance | E20-593 Test Prep and Question Bank

while working for Hewlett-Packard’s clinical community, a supervisor referred to, “When the obstacles to entry are excessive, those who overcome them have a strategic knowledge.” That adage has remained important in the context of the ever-changing regulatory approaches that are a vital part of bringing a new clinical gadget to market.

there was a good deal debate and consternation, in particular recently, about the 510(k) manner, and there'll without doubt be changes going forward. this text proposes a fundamental shift within the philosophy of how regulatory tactics could engage with the product building system and paradigm to supply more suitable effectivity and greater predictable outcomes, inspite of how regulations evolve sooner or later.

As a product clothier, it is often more convenient to criticize the manner than to work out how to make it work to your skills. although, there are steps that can be taken throughout the product design part to make the regulatory procedure greater effective. Design for regulatory can develop into a strategic abilities. this article discusses what design for regulatory’ entails and what it might suggest to incorporate regulatory thinking into the design system.

The Regulatory ChallengeWhat does design for regulatory imply? it is a procedure identical to these at the moment in follow:

  • Design for reliability.
  • Design for manufacturability.
  • Design for electromagnetic compatibility (EMC).
  • Design for testability.
  • each and every of those paradigms brings the area talents of what is considered a downstream product development pastime into the early design system. The purpose is to eliminate surprises late within the product construction technique that frequently produce bad results equivalent to high priced reworks, ignored milestones, and eventually delays in market introduction and income.

    So how do they delivery? the first aspect to do is to google “design for regulatory.” You’ll discover frequently bits of slim work on EMC and wireless design, and the internet sites of several regulatory affairs consulting companies. There are very few online search hits on how to introduce regulatory concerns into product design and even much less suggestions about that procedure for clinical product design.

    Let’s start by figuring out the goals of the regulatory strategies. In typical, they exist to be sure that protected and valuable items are delivered into the market vicinity with acceptable risk-benefit ratios. every manufacturer, clothier, regulatory skilled, clinical practitioner, and consumer has this as a typical intention. besides the fact that children, if here's the case, why are there invariably concerns?  The issues originate in the method regulatory compliance is handled during the building method. it's regularly considered as an afterthought or a necessary evil to be confirmed for and often gamed on the conclusion of the method when negative regulatory feedback is very frustrating and costly. Even one request for additional information will also be devastating to a company’s plans and fiscal neatly-being. Funding for start-usaand small agencies is often tied to regulatory milestones.1

    Some groups take hazards, purposely or not, with the aid of attempting to do the minimal required or cautiously crafting claims in the hope of getting previous FDA. however these concepts might also every now and then work, naturally they do not result in predictable success, as a result of they could lead frustrate or anger reviewers. A perceived flow toward a greater chance-averse FDA make this strategy much less likely to produce a a success result.

    So what can you do? With current ‘design for …’ processes, teams consist of the stakeholders who be sure a hit execution of the plans. similarly, groups can incorporate regulatory affairs certified (or these with extensive regulatory adventure) directly into their design groups to ensure that the regulatory issues and requirements are addressed in planning and subsequent design phases. This method encourages the crew members to use their event and advantage to design items and test programs a good way to enable the creation of regulatory-ready products.

    The group can additionally accumulate the information and analysis to aid clean submissions and with a bit of luck clearance and with any first rate multistep reform system, the 1st step is to confess that there's an issue and agree that the organization desires to resolve it. however regulatory development is complicated to music except a product is near the conclusion of the construction technique, the resources to achieve this either already exist in organizations or will also be identified and assigned (or shrunk) tasks early within the venture. Any costs concerned are restricted to the indispensable regulatory elements. There are colossal discounts to be received from limiting redecorate, additional tests, rounds of regulatory review, and delayed income.

    meant Use and signals for UseThe most important product points to agree upon within the starting of the construction procedure are supposed use and indications to be used. however the exact definition of these phrases (apart from what is equipped in 21 CFR 801.4) is currently under dialogue at FDA and may evolve, they very nearly seek advice from what the machine will do and how it might be used.agencies frequently get to the end of product development and have heated inside discussions with designers, marketers, and regulatory agencies, discovering that the aspects and claims made in submissions don't support the advertising materials. The procedure of constructing changes and realigning messaging is expensive and totally disruptive to a company. Having a transparent discussion and contract, as well as forming a written documentation up front that including intended use, signals to be used, and claims, will add consistency and predictability. The claims form the beginning aspect for submission programs, provide requirements, and force standards within the product design. Verification and validation trying out and collateral materials, reminiscent of consumer documentation and advertising substances, become smartly aligned with claims from the beginning of the manner.

    requisites and information DocumentsIndustry requirements may still be used and referenced at any place it is acceptable. standards can be a touchy discipline within the competitive industry, however they're primary for evaluating and comparing performance. businesses similar to AAMI have proven that standards may also be with no trouble developed in an open and nonthreatening forum and include all events worried.

    specifications enable businesses to correctly evaluate conformance and cling each and every machine to a minimum degree of performance. necessities do not stifle innovation however as an alternative channel it in opposition t exceeding performance and cutting back fees through concentrating enterprise efforts. They also allow direct head-to-head comparisons in the market between aggressive products.

    When a design crew makes use of necessities and tips files as design input, the files should provide the minimal necessities. Exceeding the standards can have market benefits if doing so consequences in demonstrable benefits. as an instance, IEC 60601-1-eleven requires an operating temperature latitude of 5°–forty°C for transit operable home healthcare clinical device. besides the fact that children, there are many use environments  use through which this specification can be surpassed—Fairbanks, AK has a regular low temperature of -28°C in January and Phoenix, AZ has an average hot temperature of above forty one°C in July.

    Designing and testing to a larger range can enable advertising and marketing claims of operation in less restrictive environments and will yield consumer benefits or fewer carrier and gadget failure considerations. These benefits have to be supported with acceptable facts as required with the aid of the regulatory technique.

    When there are distinctive requisites, reminiscent of international agency requirements, the regulatory and design features deserve to work together to opt for the superset for the product standards to allow easy introduction into extra markets.

    assistance files from regulatory groups aren't specifications within the literal feel, however should be treated as necessities and their ideas incorporated as design input. not taking information files seriously or assuming that they are not applicable to a product is a standard and unlucky mistake. If a corporation elects not to comply with an accessible assistance or makes use of most effective portions that it considers relevant, it will Boost and aid that justification choice early in the design procedure. moreover, all and sundry on the group should still be comfy with the determination, whereas the results of trying out to guide the determination should still be included into the early regulatory submission drafts.

    Don’t forget to evaluate draft guidances and search for prepublication drafts that may additionally supply perception into altering agency expectations. however these drafts may nevertheless be open for comments or not yet finalized, they can supply advantageous perception into FDA’s current pondering in a specific enviornment. The company has been typical to enforce draft thoughts. Paying consideration to these expectations early on saves time and labor later in the method given that drafts early in a product development cycle frequently turn into defacto requisites or are incorporated into specifications by the time the product is equipped for submission.

    Have a Regulatory StrategyOnce the machine use and requirements are understood, it is time to work on the regulatory approach. Early in the design procedure, discuss and include here key items: 

  • Proposed claims.
  • Preliminary guidance to be used.
  • Predicate equipment choices. it's also shrewd to reap the predicate device’s 510(ok) filings through Freedom of guidance Act requests.
  • equipment classification—class I, II, or III; exempt; 510(okay); or do the claims element against a PMA?
  • international advertising and marketing approach and additional regulatory company requirements: CE, fitness Canada, Federal Communications commission, medical insurance Portability and Accountability Act of 1996.
  • Packaging needs and labeling necessities, including overseas symbols and warnings.
  • comparison checking out, together with bench and medical trying out that is required to help mammoth equivalence.
  • examine plan to show conformance to existing specifications.differences between predicates and requirements, and how the changes (if any) can be represented and supported.
  • 513(g) (request for scientific equipment classification) or preinvestigational device exemption (IDE) conferences with FDA to aid assist the strategic regulatory direction.
  • the usage of off-the-shelf components or expertise to make sure their security and effectiveness with the gadget.
  • compensation method and requirements for aiding statistics—this may additionally pressure claims and extensively trade the strategic product focal point. while no longer the focus of this text, it's a vital a part of the marketing strategy for any scientific product or carrier. Create a parallel overview procedure to make coverage determinations whereas FDA clearance or approval is under dialogue.
  • These are extremely essential discussions and decisions, and it's crucial that they be correctly documented. The discussions and components evaluated that finally power the choices are only as critical to assisting the selections stick and conserving the undertaking from disruptive reanalysis tactics.

    The discussions might also bring up considerable issues and create a chance to change the design of the product to resolve regulatory issues. Designers may still now not panic or  are trying to game the system. Most commonly, a company will lose with a technique that tries to get around regulatory considerations or imprecise them.

    believe issues rationally. They may additionally result in alterations that may also be constructive for the customer or create an opportunity to raise the bar with FDA. as an instance, the ability to assemble extra device records all over use can allow extra markets if accurately exact and carried out. These sorts of points may also also be used production trying out and box provider.assessment trying out and information assortment cannot be overemphasized. an organization can create a submission that offers it an abilities over rivals by means of including impressive comparative information past that which was provided in past submissions. These identical statistics can then be used for advertising applications, making it complex and expensive for rivals to reply as soon as the product is delivered into the market and extending the hurdles they’ll face when submitting statistics for a future product.

    agree with the pre-IDE meeting and latest your design for regulatory compliance case to FDA. assisting the agency take into account that the gadget is designed to be a proactive part of the regulatory manner can support the enterprise benefit support from the community that may be reviewing the submission. The pre-IDE assembly is effective for picking out considerations and setting up allies at FDA.

    prepare Submission files throughout Product DesignOnce the enter requirements and product standards are finished, the design team may have a whole lot of the advice that it should create regulatory submissions for all countries within the business plan. although the examine facts are missing, the tables can also be created proforma to be stuffed in with the acceptable passing verification and validation statistics as those assessments are achieved.

    All too commonly, these files are prepared plenty later within the process. it is less difficult and less expensive to make changes early in the system. Regulatory alterations are not any diverse, except that during the past, groups have hardly ever considered altering items to facilitate more convenient and extra comprehensive regulatory approvals. instead, they alter product claims and limit the market competencies for their machine. in the long run, this strategy is more high priced.developing these documents early enables a corporation to identify and repair deficiencies extraordinarily without problems and at budget friendly. Early creation of those files may also also alter the regulatory strategy.

    Hazard AnalysisSurprises within the regulatory manner can commonly be traced again to hazard analysis. For the functions of this text, the time period hazard analysis is used as a extensive category to consist of failure modes and results analysis and all other applicable risk and hazard analysis strategies as acceptable to scientific contraptions.

    considerations continually come up from the omission of hazards linked to new applied sciences (such as replacing a cable the usage of instant technology) or unrealistic scoring of the hazard or its mitigation. even if this outcomes from a scarcity of appreciation for brand new dangers or unquestioning reuse of the analysis from the previous product generation, omitting them can result in huge issues.

    This analysis gives a different probability to design for regulatory because it provides extra input necessities. Product design changes doubtlessly supply the strongest mitigations and are once in a while the cost-efficient. Design adjustments early in the process are lots low cost and time-drinking than creation tweaks. elements may also be introduced to provide additional safety or robustness to data, and extra elements can aid in verification for other mitigation projects that may additionally no longer be latest in the core product aspects and specifications.

    first rate assistance for hazard analysis is provided in ISO 14971, and it's always very effective to carefully overview the evaluation of predicate devices.

    holding and Patenting features for CompliancePay certain consideration to any facets brought to a product to facilitate the regulatory submission, corresponding to those permitting for facts assortment during verification or validation checking out, or those mitigating risks. overview of those aspects and their implementation may locate patentable material and once again, competitive benefits. Patents do not deserve to be flashy to be valuable in making it complex for a competitor to execute its regulatory strategy. believe any function that has been delivered on account of the regulatory evaluate or a distinct design aspect that makes it possible for less difficult demonstration of safety or efficacy for coverage.

    Design the examine ProgramCreating the regulatory plan and prototype submission early allows for some creativity in combining points to make the optimum checking out program. for example, all over the setup trying out phase for a new product, testing of predicate and competitive products may also be carried out with minimal additional work and value. it's valuable to know the way the competitors performs now not best for the regulatory submission, however additionally for product marketing functions. If a key product efficiency influence will also be identified and supported in its value to the product or for the consumer, FDA might recognize it as a requirement for future products submitted by means of competition.

    incredibly accelerated lifestyles testing and particularly accelerated stress screening testing are astounding methods. however, don't underestimate the price of testing the boundaries all through normal performance checking out.

    A test application will regularly adhere to the internal and advertised necessities to set look at various limits. This assistance is elementary for submissions, but whereas a test is install, it can also be very useful to proceed the testing to establish design margins and probably helpful characterization suggestions. This information can help show the robustness of a design and could permit for an expanded ensure to the customer or decrease gathered ensure cost expectations.check failures are inevitable. Fixing considerations that are recognized all the way through validation or verification actions provides one more opportunity to agree with the large image and encompass regulatory considerations.

    although EMC has bought consideration from the agency (together with institution of a relationship with the FCC), don’t neglect that it's additionally an issue for the customer. EMC testing of competitive items can yield an knowing of skills interactions in addition to their product weaknesses. it'll allow design alterations that make items more appropriate and support the consumer with constructive installation and operation assistance. It may additionally probably supply sales and advertising departments positive aggressive data.

    Design groups and FDA SubmissionThe designers have pleasing perception into the product and its technology. it is an skills to use this advantage in drafting specific sections of the submission, technology descriptions, and comparisons. considering that the entire crew has been concerned in the technique, each person should be proactive and engaged. There is generally sections of the submission that can be reused directly from product design files, because they  comprise helping cloth corresponding to drawings.

    Reviewers Are Your FriendsFinally, the reviewer is your chum; the design team should trust this observation too. Make it a primary goal to teach your reviewer(s). they have an incredible workload that contains various items and can not have the depth of knowledge and competencies to thoroughly recognize your product. consider about assisting a chum take into account this first rate new product and also you’ll have an improved submission.

    schooling is even more crucial if this product introduces a brand new know-how or method. Don’t assume that once it looks on Wikipedia your reviewer may be an authority. once here's established as an working precept, first rate things can turn up. people will think about the way to make the reviewer’s job less demanding through presenting stunning information and helping fabric. Any new or complicated ideas may be accompanied with the aid of amazing trade and peer-reviewed reference material. Reviewer-friendly submissions will assist you benefit allies at FDA.

    ConclusionDesign for regulatory is a beneficial thought, inspite of future adjustments to agency necessities or techniques. different ‘design for…’ paradigms have proven that up-entrance, early consideration of initiatives that are always performed on the conclusion of the product development manner reduces time to market and fees linked to redesign.youngsters following the tips in this article isn't devoid of charge, doing so is a worthwhile funding. The construction of a pretty good regulatory strategy and the incorporation of regulatory resources into the design method will make sure fewer surprises and permit for more effective and potentially less difficult FDA submissions. This paradigm can also yield improved aggressive tips and product positioning and doubtlessly create a competitive competencies within the marketplace.

    Reference1. Conroy S, “decreased VC money skill New Challenges for Medtech delivery-Ups,” MD+DI 32, no. 10 (2010): 18; available from information superhighway:

    invoice Saltzstein is founder of Code Blue Communications Inc. (Woodinville, WA). 

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