EMC E20-893 : NetWorker Expert exam for Implementation Engineers Exam

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Exam Number : E20-893
Exam Name : NetWorker Expert exam for Implementation Engineers
Vendor Name : EMC
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Exam Title : Dell EMC Certified Expert - Implementation Engineer - NetWorker
Exam ID : E20-893
Exam Duration : 90 mins
Questions in exam : 60
Passing Score : 60%
Exam Center : Pearson VUE
Real Questions : Dell EMC NetWorker Expert Implementation Engineers Real Questions
VCE Practice Test : Dell EMC E20-893 Certification VCE Practice Test

NetWorker Deployment and Performance Management 15%
- Describe the best practices for NetWorker configuration, sizing, and performance management
- Describe the best practices for planning and configuring resources for backup operations

Integrating NetWorker with Microsoft Products 31%
- Explain NetWorker integration with Microsoft SQL; including configuration, use, and considerations
- Explain NetWorker integration with Microsoft Exchange; including configuration, use, and considerations
- Explain NetWorker integration with Microsoft SharePoint; including configuration, use, and considerations

Integrating NetWorker with Databases and Applications 18%
- Explain NetWorker integration with Oracle; including configuration, use, and considerations
- Explain NetWorker integration with SAP/SAP HANA; including configuration, use, and considerations
- Identify and describe the best practices for integrating NetWorker with MEDITECH

Integrating NetWorker with Virtual Environments 24%
- Describe how to configure and use NetWorker to back up and restore Hyper-V virtual machines
- Describe how to configure and use NetWorker to back up and restore VMware virtual machines
- Explain how to deploy and configure NetWorker Virtual Edition

Integrating NetWorker with Other Dell EMC Products 12%
- Identify and describe the best practices for integrating NetWorker with Data Domain
- Identify and describe the best practices for integrating NetWorker with ProtectPoint

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EMC Implementation education

Design for Regulatory Compliance | E20-893 PDF Braindumps and PDF Download

while working for Hewlett-Packard’s scientific group, a manager mentioned, “When the boundaries to entry are high, those who overcome them have a strategic knowledge.” That adage has remained important in the context of the ever-altering regulatory procedures that are an essential component of bringing a brand new clinical equipment to market.

there has been a whole lot debate and consternation, above all these days, in regards to the 510(k) process, and there will surely be adjustments going forward. this article proposes a fundamental shift in the philosophy of how regulatory methods could have interaction with the product construction manner and paradigm to supply enhanced efficiency and greater predictable outcomes, inspite of how rules evolve sooner or later.

As a product clothier, it's commonly more convenient to criticize the procedure than to determine the way to make it work to your knowledge. despite the fact, there are steps that may also be taken all through the product design section to make the regulatory procedure extra advantageous. Design for regulatory can turn into a strategic competencies. this article discusses what design for regulatory’ entails and what it would suggest to include regulatory pondering into the design process.

The Regulatory ChallengeWhat does design for regulatory imply? it is a technique similar to these presently in apply:

  • Design for reliability.
  • Design for manufacturability.
  • Design for electromagnetic compatibility (EMC).
  • Design for testability.
  • every of these paradigms brings the domain capabilities of what's considered a downstream product construction activity into the early design method. The purpose is to eliminate surprises late in the product construction manner that frequently produce terrible results reminiscent of costly reworks, neglected milestones, and subsequently delays in market introduction and earnings.

    So how do we beginning? the first issue to do is to google “design for regulatory.” You’ll locate commonly bits of narrow work on EMC and instant design, and the internet websites of a number of regulatory affairs consulting groups. There are only a few online search hits on how to introduce regulatory concerns into product design and even less advice about that procedure for clinical product design.

    Let’s beginning with the aid of figuring out the goals of the regulatory techniques. In general, they exist to make sure that secure and effective products are delivered into the market vicinity with acceptable possibility-advantage ratios. every brand, clothier, regulatory skilled, clinical practitioner, and consumer has this as a typical aim. despite the fact, if here's the case, why are there always issues?  The issues originate within the way regulatory compliance is handled all the way through the development process. it's often viewed as an afterthought or a quintessential evil to be established for and sometimes gamed at the conclusion of the manner when poor regulatory feedback is awfully irritating and costly. Even one request for more information can also be devastating to a company’s plans and fiscal well-being. Funding for birth-united statesand small corporations is commonly tied to regulatory milestones.1

    Some groups take hazards, purposely or now not, with the aid of trying to do the minimum required or cautiously crafting claims in the hope of getting previous FDA. youngsters these concepts might also every now and then work, certainly they don't cause predictable success, because they can lead frustrate or anger reviewers. A perceived stream towards a greater possibility-averse FDA make this method much less likely to produce a a hit influence.

    So what are you able to do? With present ‘design for …’ processes, teams encompass the stakeholders who be sure a success execution of the plans. similarly, corporations can include regulatory affairs professionals (or those with extensive regulatory journey) directly into their design groups to be sure that the regulatory considerations and necessities are addressed in planning and subsequent design phases. This approach encourages the team participants to make use of their adventure and expertise to design products and look at various courses which will allow the creation of regulatory-able products.

    The team can also gather the information and evaluation to guide clean submissions and hopefully clearance and approvals.as with any respectable multistep reform process, the first step is to admit that there is a problem and agree that the organization wants to solve it. although regulatory growth is tricky to tune except a product is near the conclusion of the construction method, the components to do so either exist already in corporations or can also be recognized and assigned (or reduced in size) tasks early in the venture. Any expenses involved are restricted to the critical regulatory materials. There are colossal reductions to be won from limiting redecorate, further checks, rounds of regulatory evaluate, and delayed earnings.

    supposed Use and signals for UseThe most vital product points to agree upon within the beginning of the building procedure are meant use and signs for use. although the real definition of those terms (apart from what is equipped in 21 CFR 801.four) is currently under dialogue at FDA and should evolve, they practically check with what the gadget will do and how it might be used.groups frequently get to the conclusion of product building and have heated internal discussions with designers, marketers, and regulatory organizations, discovering that the aspects and claims made in submissions do not help the advertising substances. The procedure of constructing changes and realigning messaging is expensive and particularly disruptive to an organization. Having a transparent dialogue and contract, in addition to forming a written documentation up entrance that together with supposed use, indications to be used, and claims, will add consistency and predictability. The claims kind the beginning element for submission applications, provide requirements, and pressure necessities within the product design. Verification and validation trying out and collateral substances, equivalent to user documentation and advertising substances, develop into neatly aligned with claims from the beginning of the technique.

    requisites and suggestions DocumentsIndustry requirements should still be used and referenced wherever it's appropriate. requisites can be a sensitive subject in the competitive industry, but they're essential for evaluating and comparing efficiency. corporations such as AAMI have shown that requisites may also be readily developed in an open and nonthreatening discussion board and include all events worried.

    specifications permit groups to successfully evaluate conformance and grasp each and every gadget to a minimal degree of efficiency. standards don't stifle innovation however as a substitute channel it towards exceeding efficiency and reducing costs by means of concentrating company efforts. They additionally enable direct head-to-head comparisons within the industry between competitive items.

    When a design team uses requisites and tips files as design input, the documents should supply the minimum necessities. Exceeding the standards can have market benefits if doing so effects in demonstrable merits. for instance, IEC 60601-1-11 requires an working temperature latitude of 5°–forty°C for transit operable home healthcare medical device. although, there are many use environments  use wherein this specification may well be passed—Fairbanks, AK has a regular low temperature of -28°C in January and Phoenix, AZ has an average extreme temperature of above forty one°C in July.

    Designing and trying out to a bigger latitude can permit advertising claims of operation in less restrictive environments and will yield customer advantages or fewer service and device failure considerations. These advantages should be supported with appropriate evidence as required via the regulatory method.

    When there are diverse necessities, corresponding to foreign company necessities, the regulatory and design functions deserve to work collectively to choose the superset for the product specifications to allow easy introduction into additional markets.

    guidance documents from regulatory organizations aren't specifications within the literal sense, but may still be treated as necessities and their techniques included as design enter. not taking tips files critically or assuming that they aren't relevant to a product is a standard and unlucky mistake. If a corporation elects not to observe an purchasable guidance or makes use of handiest parts that it considers applicable, it'll boost and help that justification determination early within the design method. additionally, everybody on the team should be at ease with the resolution, while the results of testing to help the determination may still be incorporated into the early regulatory submission drafts.

    Don’t forget to evaluate draft guidances and seek prepublication drafts that may also supply insight into altering agency expectations. although these drafts might also nevertheless be open for comments or now not yet finalized, they could provide constructive insight into FDA’s existing pondering in a particular enviornment. The agency has been standard to enforce draft thoughts. Paying consideration to these expectations early on saves time and labor later within the process because drafts early in a product development cycle commonly turn into defacto specifications or are included into requisites by the point the product is equipped for submission.

    Have a Regulatory StrategyOnce the machine use and standards are understood, it is time to work on the regulatory method. Early within the design method, talk about and consist of here key objects: 

  • Proposed claims.
  • Preliminary guidelines to be used.
  • Predicate machine decisions. it's additionally smart to acquire the predicate machine’s 510(ok) filings via Freedom of counsel Act requests.
  • equipment classification—class I, II, or III; exempt; 510(ok); or do the claims factor in opposition t a PMA?
  • international advertising approach and further regulatory agency requirements: CE, health Canada, Federal Communications fee, health insurance Portability and Accountability Act of 1996.
  • Packaging wants and labeling necessities, together with foreign symbols and warnings.
  • evaluation trying out, including bench and scientific testing that is required to help big equivalence.
  • check plan to exhibit conformance to existing requirements.transformations between predicates and specifications, and the way the alterations (if any) can be represented and supported.
  • 513(g) (request for clinical equipment classification) or preinvestigational equipment exemption (IDE) conferences with FDA to support guide the strategic regulatory route.
  • the use of off-the-shelf accessories or expertise to make sure their security and effectiveness with the equipment.
  • repayment method and requirements for helping facts—this can also force claims and noticeably trade the strategic product focal point. while now not the focus of this article, it's a vital a part of the business plan for any scientific product or carrier. Create a parallel evaluate manner to make coverage determinations while FDA clearance or approval is beneath dialogue.
  • These are extraordinarily critical discussions and selections, and it's integral that they be appropriately documented. The discussions and components evaluated that finally pressure the choices are only as vital to helping the decisions stick and holding the venture from disruptive reanalysis methods.

    The discussions can also deliver up great concerns and create an opportunity to alter the design of the product to unravel regulatory concerns. Designers should still now not panic or  are trying to game the equipment. Most regularly, a corporation will lose with a methodology that tries to get around regulatory concerns or obscure them.

    accept as true with considerations rationally. They may also lead to alterations that can be constructive for the customer or create a chance to elevate the bar with FDA. for example, the capability to collect extra gadget records all through use can enable extra markets if competently specified and carried out. These styles of features may even be used construction trying out and container carrier.comparison checking out and facts collection can't be overemphasized. a company can create a submission that offers it an potential over competitors through together with remarkable comparative statistics past that which turned into supplied in previous submissions. These same statistics can then be used for advertising functions, making it complicated and costly for rivals to respond once the product is introduced into the market and lengthening the hurdles they’ll face when submitting information for a future product.

    consider the pre-IDE meeting and existing your design for regulatory compliance case to FDA. assisting the company keep in mind that the device is designed to be a proactive part of the regulatory procedure can assist the enterprise gain guide from the neighborhood that could be reviewing the submission. The pre-IDE assembly is helpful for deciding on considerations and organising allies at FDA.

    prepare Submission documents all the way through Product DesignOnce the enter necessities and product specifications are finished, the design team will have a lot of the counsel that it needs to create regulatory submissions for all nations in the business plan. besides the fact that children the test statistics are missing, the tables may also be created proforma to be filled in with the applicable passing verification and validation information as those exams are accomplished.

    All too commonly, these files are organized plenty later in the procedure. it's more convenient and less expensive to make alterations early within the process. Regulatory changes are no distinctive, apart from that during the past, agencies have hardly regarded altering items to facilitate less difficult and extra complete regulatory approvals. instead, they alter product claims and restrict the market potential for his or her device. in the long run, this method is more high priced.developing these documents early permits a company to identify and fix deficiencies highly readily and at least expensive. Early advent of those documents can also also alter the regulatory strategy.

    Hazard AnalysisSurprises within the regulatory method can regularly be traced returned to hazard evaluation. For the purposes of this text, the time period hazard evaluation is used as a extensive class to encompass failure modes and effects analysis and all other appropriate risk and hazard analysis methods as applicable to medical gadgets.

    concerns constantly arise from the omission of hazards associated with new technologies (reminiscent of changing a cable using instant know-how) or unrealistic scoring of the hazard or its mitigation. whether this effects from an absence of appreciation for brand new dangers or unquestioning reuse of the analysis from the previous product generation, omitting them can lead to big issues.

    This evaluation offers another probability to design for regulatory because it offers additional enter necessities. Product design adjustments potentially provide the strongest mitigations and are from time to time the low-priced. Design alterations early in the method are much cheap and time-drinking than production tweaks. features can also be delivered to deliver extra safety or robustness to information, and further elements can help in verification for different mitigation tasks that may also not be latest in the core product facets and standards.

    decent assistance for hazard evaluation is provided in ISO 14971, and it's always very positive to cautiously review the evaluation of predicate devices.

    keeping and Patenting elements for CompliancePay selected consideration to any aspects introduced to a product to facilitate the regulatory submission, such as these enabling for records assortment right through verification or validation trying out, or those mitigating hazards. assessment of those aspects and their implementation might discover patentable material and as soon as once more, aggressive merits. Patents do not need to be flashy to be useful in making it complex for a competitor to execute its regulatory method. agree with any function that has been delivered because of the regulatory assessment or a distinct design aspect that allows for more straightforward demonstration of defense or efficacy for coverage.

    Design the test ProgramCreating the regulatory plan and prototype submission early makes it possible for some creativity in combining facets to make the most efficient trying out application. as an instance, all over the setup checking out phase for a brand new product, trying out of predicate and aggressive items can be carried out with minimal extra work and value. it is effective to understand how the competitors performs not handiest for the regulatory submission, but additionally for product advertising purposes. If a key product efficiency outcomes will also be identified and supported in its value to the product or for the consumer, FDA could recognize it as a requirement for future products submitted by competition.

    totally accelerated lifestyles trying out and totally accelerated stress screening trying out are magnificent methods. however, don't underestimate the value of checking out the boundaries all the way through general efficiency trying out.

    A verify application will commonly adhere to the inside and marketed requisites to set look at various limits. This assistance is standard for submissions, however while a verify is set up, it will also be very helpful to proceed the checking out to set up design margins and probably beneficial characterization counsel. This suggestions can help show the robustness of a design and might allow for an accelerated warranty to the customer or lower gathered ensure cost expectations.examine disasters are inevitable. Fixing considerations that are recognized throughout validation or verification actions offers an additional chance to accept as true with the huge picture and consist of regulatory considerations.

    however EMC has obtained consideration from the company (together with establishment of a relationship with the FCC), don’t neglect that it's additionally an argument for the client. EMC trying out of aggressive products can yield an realizing of capabilities interactions in addition to their product weaknesses. it is going to allow design alterations that make products extra appropriate and aid the consumer with valuable setting up and operation tips. It could also doubtlessly provide revenue and advertising and marketing departments effective aggressive information.

    Design teams and FDA SubmissionThe designers have wonderful perception into the product and its know-how. it's an potential to make use of this skills in drafting certain sections of the submission, technology descriptions, and comparisons. for the reason that the entire group has been involved within the technique, each person may be proactive and engaged. There will likely be sections of the submission that can be reused directly from product design files, as a result of they  comprise helping material reminiscent of drawings.

    Reviewers Are Your FriendsFinally, the reviewer is your pal; the design group should believe this commentary too. Make it a main aim to show your reviewer(s). they have an immense workload that carries numerous products and might now not have the depth of abilities and expertise to utterly respect your product. consider about helping a chum take into account this first-rate new product and you’ll have a much better submission.

    schooling is much more important if this product introduces a new expertise or method. Don’t count on that once it seems on Wikipedia your reviewer may be an expert. once here's dependent as an operating principle, respectable things can turn up. individuals will suppose about how to make the reviewer’s job more convenient by way of proposing amazing data and aiding cloth. Any new or complicated ideas could be accompanied by brilliant trade and peer-reviewed reference cloth. Reviewer-pleasant submissions will support you benefit allies at FDA.

    ConclusionDesign for regulatory is a effective concept, inspite of future adjustments to company necessities or tactics. different ‘design for…’ paradigms have shown that up-front, early consideration of tasks that are always performed on the conclusion of the product building procedure reduces time to market and costs associated with remodel.youngsters following the advice in this article is not devoid of cost, doing so is a rewarding funding. The construction of an excellent regulatory method and the incorporation of regulatory elements into the design system will make certain fewer surprises and enable for greater effective and potentially less difficult FDA submissions. This paradigm can also yield more advantageous aggressive information and product positioning and probably create a competitive skills within the marketplace.

    Reference1. Conroy S, “decreased VC dollars potential New Challenges for Medtech beginning-Ups,” MD+DI 32, no. 10 (2010): 18; available from web: http://www.mddionline.com/article/reduced-vc-cash-skill-new-challenges-medtech-birth-ups.

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

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