RAPS RAC-GS Exam Prep
Regulatory Affairs Certification (RAC) Global Scope (Page 2 )

• Which batches and markets are affected
• Whether the deficiency affects product quality, efficacy, or patient safety
• Whether the issue is an ongoing manufacturing problem
• Whether immediate containment or distribution suspension is needed

• A — Withdraw the product: may be necessary, but is premature before assessing the risk.
• B — “Dear Dr.” letter: may be appropriate later, depending on the risk.
• C — Notify global authorities: may become mandatory, but the scope and urgency depend on the assessment.

• Deficiency found before patient use: usually does not require an adverse-event report because no patient exposure occurred.
• Event caused solely by the patient’s condition: may not be reportable if the device did not contribute.
• Malfunction protection operated correctly: generally exempt when the device’s safety mechanism worked as intended and prevented harm.

• Correct answer: D — Promote off-label use to a carefully selected patient population.

• Conditional approval means confirmatory studies are still required. To minimize risk during this period, you should implement risk minimization actions that keep use within approved terms.
• Labeling for appropriate populations ensures clinicians and patients know exactly who the product is intended for.
• Educating patients and healthcare providers reduces misuse and misinterpretation of how to use the product.
• Delaying product launch limits patient exposure to potential unknown risks until safety/efficacy are confirmed.
• Promoting off-label use is least effective (and inappropriate): it increases risk, bypasses approved indications, and undermines regulatory commitments. Off-label use lacks the evidentiary basis and regulatory safeguards of approved indications.

• Domínios personalizados.
• Armazenamento suficiente.
• Instâncias dedicadas.
• Balanceamento de carga.
• Menor custo entre os planos que atendem a tudo.

• B: Developer Edition has limited user, storage, and data-volume capacity, making realistic community testing difficult.
• C: A Developer Edition org cannot contain sandboxes, so it cannot provide separate environments for development, integration, and UAT.
• E: A standalone Developer Edition org is not part of the production org’s deployment path, so change sets cannot be used to deploy from it directly to that production org. The team would need Metadata API, Salesforce CLI, or another deployment method.

• CHAP: Uses a challenge-response exchange, so the password is not directly transmitted.
• IPsec: Provides authentication, integrity, and encryption for IP communications.
• EAP: An authentication framework that supports stronger methods, such as certificates or token-based authentication.

1. Create a temporary Onboarding OU.
2. Move the new account into it.
3. Move the restrictive SCPs from the organization root to the Production OU.
4. Allow the account to update AWS Config.
5. Move the account into Production after onboarding.

• An SCP attached at the organization root applies to every account and OU beneath it.
• An SCP attached to the Production OU applies only to accounts in that OU.
• Therefore, moving the restrictive SCP from the root to Production temporarily exempts the onboarding account without weakening the policies for existing production accounts.
• Once onboarding is complete, moving the account into Production subjects it to the normal restrictions.

• Deterministic approve/reject results
• Strict adherence to predefined rules
• Consistent, reproducible outcomes
• Auditability and regulatory compliance

• SQL injection
• Cross-site scripting (XSS)
• Malicious or malformed web requests
• Some application-layer abuse

• Layer 4 firewall: Filters based mainly on IP addresses, ports, and connections; it lacks detailed web-request inspection.
• NGFW: Provides broader network security, but a WAF is more specialized for protecting web applications.
• UTM: Combines multiple security functions, but it is not necessarily optimized for web-application protection.

• A password cracker would normally be identified by behavior such as loading password hashes or attempting dictionary/brute-force attacks.
• The question describes a routine audit, not password recovery.
• Simply encountering a protected file during an audit is characteristic of a misconfigured or insufficiently privileged FIM.

• A user connects with their Google account.
• Google associates the user’s SSH key with that identity.
• IAM roles determine whether they can log in.
• Access can be tied to a specific employee for auditing.
• Removing the IAM role removes their login access.

• compute.osLogin: regular OS login access
• compute.osAdminLogin: OS login with administrative privileges, typically including sudo

text 
enable-oslogin=TRUE

• New investment: $536,500
• Resulting NPV: $0

• B — Incorporate contextual output encoding/escaping: Encode untrusted data based on its context—HTML, attribute, JavaScript, or URL—so the browser treats it as data rather than executable code.
• D — Run untrusted HTML input through an HTML sanitization engine: Sanitization removes or neutralizes dangerous elements and attributes, such as script-related content, while preserving safe HTML where needed.

• A: Enabling client-side scripts does not prevent XSS. Script restrictions may reduce risk in some environments, but “enable” is not a general XSS control.
• C: Cookie inspection is unrelated to preventing injected scripts.
• E: The SameSite cookie attribute primarily helps mitigate CSRF, not XSS. It should not generally be described as an XSS prevention measure.

• Render thousands of animation frames
• Generate product images in multiple sizes
• Apply filters or transformations to a large image collection
• Produce visual effects for a video

• Data source: Folder
• Transformation: Remove the Content column (or keep only the file-metadata columns)

Why

• File name
• Extension
• Date modified
• Folder path
• Content — the binary contents of the file

1. The original app version exists.
2. You create and publish a new version, so there are now two versions.
3. When you restore the previous version, Power Apps does not delete or overwrite the newer version. Instead, it creates another version based on the restored one.

• Original version
• Newly created and published version
• New version created by the restore operation

• What information each stakeholder needs
• When and how often it should be communicated
• Which format or channel should be used
• Who is responsible for communicating it

• A: The team should not decide stakeholder communications without first checking the established plan and CEO’s needs.
• B: An executive summary may be appropriate, but choosing a solution before reviewing the plan is premature.
• D: The stakeholder engagement plan addresses how to engage stakeholders, but this is primarily a communication planning issue.

Statement 1 — Correct

Statement 2 — Correct

• Economy: Obtaining inputs at the lowest appropriate cost.
• Efficiency: Making the best use of resources, such as staff, money, and equipment.
• Effectiveness: Achieving the intended objectives or outcomes.

• Who owns security risks and decisions
• Who is responsible for implementing controls
• Who reports security performance to management
• How security responsibilities align with business objectives

• B — Compliance with audit requirements: Governance may support compliance, but audit compliance is not its main objective.
• C — Monitoring security incidents: This is an operational security activity, not the central purpose of governance.
• D — Creation of tactical solutions: Governance establishes direction and oversight; tactical solutions belong to management and operational teams.

• Crowd-sourced evaluation: Requires recruiting and managing many evaluators.
• Human-worker evaluation: Provides human judgment but requires coordination, labeling instructions, and quality control.
• RLHF: Is a training and alignment process, not simply a low-overhead model comparison method.
• Automatic model evaluation: Quickly evaluates outputs using predefined toxicity or quality metrics with minimal manual effort.

• The requirement is to obtain an assessment of the Azure environment’s design.
• The proposed solution is the Premier support plan.
• Premier can provide this type of guidance, but it is a higher-tier, more expensive option.
• The question specifically says to keep costs to a minimum. A lower tier—typically Professional Direct in the support-plan model used by this question—provides architectural/design guidance.

• Repetitive and time-consuming
• Based on measurable conditions, such as last check-in time
• Easy to automate with alerts, dashboards, or scheduled reports
• Important for ensuring scan coverage

• Assigning custom recommendations usually requires analyst judgment and context.
• Analyzing false positives can sometimes be assisted by automation, but validation often requires human review.
• Rendering an additional executive report increases reporting activity rather than reducing a core operational workload.

• Portfolio definition cycle — establishes and maintains the portfolio strategy, objectives, and management framework.
• Portfolio delivery cycle — coordinates and monitors the delivery of change initiatives, ensuring the portfolio remains aligned with strategic objectives and delivers value.

• Practice — a structured area of portfolio management activity, such as risk management or resource management.
• Technique — a method used to perform an activity; it is not the term for portfolio delivery itself.
• Principle — a guiding rule for effective portfolio management.

• B — The glass core component is encased in a cladding.

• D — Light is transmitted through the core of the fiber.

• BNC connectors are associated mainly with coaxial copper cabling, not standard fiber connections.
• Data does not pass through the cladding; the cladding helps reflect and contain the light.
• RJ-45 connectors are used with copper Ethernet cabling, not fiber-optic interfaces.

• Accept: Acknowledge the risk and take no additional action.
• Transfer: Shift the risk or financial impact to another party, such as through insurance or a contract.
• Mitigate: Reduce the likelihood or impact using controls, such as firewalls, training, or backups.
• Avoid: Eliminate the activity that creates the risk.

• A: It allows for branching and merging...

• C: It allows multiple engineers to work against the same code and configuration files and manage differences and conflicts.

• B: Build automation and infrastructure provisioning are handled by CI/CD and automation tools, not by version control alone.
• D: User Stories and backlogs are managed by project-management tools.
• E: Version control stores and tracks code, but it does not itself ensure that developers write effective unit tests.

• Data Cloud combines data from multiple systems.
• It resolves and organizes that data into a unified customer view.
• That unified view enables downstream actions such as personalized campaigns, segmentation, analytics, and activation.

• A = core platform value
• D = a resulting business use case or benefit

• Bronze: Raw ingested data
• Silver: Cleaned, validated, and transformed data
• Gold: Business-level data for analytics, dashboards, and reporting

• Domain controllers, because the requirement specifically excludes them. However, note that both member servers and domain controllers run Windows Server, so OS targeting alone cannot distinguish them unless the targeting option allows selecting the relevant server role/version. In the usual exam interpretation, target the applicable server OS category.
• Client computers, because they run a client Windows operating system.

• Domain: Targets membership in a domain, not the computer’s operating-system type.
• Security Group: Would require creating and maintaining a group containing all member servers, increasing administrative effort.
• Environment Variable: Not designed to reliably identify member servers.

• The listener uses a virtual IP address shared by the availability-group replicas.
• Floating IP, also called Direct Server Return (DSR), allows the SQL Server nodes to respond using the listener’s IP address rather than their individual VM IP addresses.
• This is required for the availability-group listener to function correctly with an Azure internal load balancer.

• Remote and global work: Access is based on the approved device, not a specific office or geographic location.
• Seamless login: Users may not need to repeatedly enter credentials on a recognized device.
• Limited equipment: It uses devices employees already have rather than requiring separate hardware.

• Geotagging: Restricts access based on location and may prevent legitimate remote work.
• Smart cards: Require issuing and managing additional physical equipment.
• Time-based logins: Limit access by time and do not provide a seamless authentication experience.

• Amazon EC2 instances — ???????? ?? ?? ??????? CPU, memory ??? instance size ???????? ???????
• AWS Lambda functions — memory configuration ?????????? ???????
• Amazon EBS volumes — volume type ?? size optimize ???? ???????
• ??????? ECS workloads — resource configuration ? cost optimization-?? ???????

• Memory ? compute usage ?????????? ???? custom code ????? ???? development ? maintenance ??????
• Cost allocation tags ???? ????? ??? ?????? ???? ??????? ???; inefficient resource ??????? ?? recommendation ???? ???
• CloudTrail resource ???? ?? API activity ??????, resource utilization ????

• Customers may boycott V’s products.
• Supermarket customers may stop buying from V.
• Investors may view V as having higher legal, ethical and reputational risk.
• V could face fines, lawsuits, contract losses and higher costs.
• Expected future profits may fall.

• Liability accounts (2000–2999) would incorrectly require dimensions, although they should have none.
• Expense accounts (6000–6998) would incorrectly require Customer, which should be optional.
• Account 6999 needs a separate rule because it requires all four dimensions, including Customer.

• 2000–2999: no dimensions
• 4000–4999: Department and Division required; Project and Customer optional
• 6000–6998: Department, Division, and Project required; Customer optional
• 6999: Department, Division, Project, and Customer required

• Password spraying: Tries a few common passwords against many accounts; no indication of repeated login attempts.
• Remote-access Trojan (RAT): Could install malware, but it does not explain how the attacker obtained the administrator’s credentials.
• Dictionary attack: Tries words or common passwords against an account; again, the scenario specifically highlights Telnet’s lack of encryption.

• Azure Machine Learning Studio is designed to build, test, train, and deploy machine-learning models, including predictive analytics.
• Azure Cosmos DB is a globally distributed NoSQL database. It can store data used by an AI solution, but it is not the primary service for developing and deploying predictive models.
• Therefore, the appropriate recommendation is Azure Machine Learning Studio, as shown in Question 15.

• Highly polished, organization-wide presentations
• Advanced dashboard design and customization
• Broader business-user distribution and interaction
• Specialized BI governance and modeling features

• 50% memory utilization baseline: The environment can be provisioned with excess capacity, leaving room for growth and workload spikes.
• Storage scalability: Cloud storage can generally be expanded as needed without redesigning the physical platform.
• Single circuit failure resilience: A properly designed IaaS provider uses redundant power circuits and infrastructure, so failure of one circuit should not take the platform offline.

• A — Dual PDUs: Helps with power redundancy but does not provide storage scalability.
• C — Network load balancing: Provides network-path resilience, not memory or storage scalability, and does not address a power-circuit failure.
• D — Multiple NAS devices: May improve storage capacity, but does not inherently provide power resilience or the required compute-capacity baseline.

• Espionage: Stealing information for intelligence or competitive purposes.
• Data exfiltration: Unauthorized removal or transfer of data.
• Nation-state attack: An attack sponsored or conducted by a government.
• Shadow IT: Unapproved technology or methods used to access organizational resources.

• Microsoft manages the physical datacenter, hardware, and virtualization.
• You manage the virtual machine’s operating system, installed software, configuration, and data.
• You choose the VM size, storage, networking, and scaling options.

• SaaS: You consume a complete application managed by the provider, such as Microsoft 365.
• PaaS: You deploy applications without managing the underlying operating system or VM infrastructure, such as Azure App Service.

• Controlar o fluxo de dados entre S3 e SageMaker;
• Aplicar regras de segurança por meio da VPC;
• Reduzir a exposição dos dados;
• Permitir acesso privado ao bucket do S3.

• Amazon Inspector: avalia vulnerabilidades, mas não gerencia o fluxo de dados.
• Amazon Macie: ajuda a descobrir e proteger dados sensíveis no S3, mas não cria a conexão com o SageMaker.
• S3 Glacier Deep Archive: é uma classe de armazenamento para arquivamento, não uma solução de conectividade.

• Dark web: A place where leaked credentials may be sold or shared, not usually the original source.
• Threat feeds: Collections of intelligence about threats, not a typical leakage source.
• State actors: A type of attacker, not an accidental corporate disclosure source.
• Vulnerability databases: Track known vulnerabilities, rather than leaked credentials.

• Use the grant-date fair value: $30
• Do not remeasure to the year-end value of $45
• Update the estimate of employees expected to vest

• Dr Share-based payment expense $450,000
• Cr Equity/share option reserve $450,000

• The audience and stakeholders
• The complexity and type of requirements
• The communication method and level of detail needed
• Whether to use diagrams, models, documents, demonstrations, or slides

• B: Authority to host the presentation is not the key preparation activity.
• C: Stakeholder sign-off may occur later; presenting requirements does not always require formal approval beforehand.
• D: A scribe may be useful in a meeting, but hiring one is not a core preparation requirement for presenting.

• Technical platform interfaces: Important for integration and interoperability, but they should support—not drive—the architecture.
• Scalability of the network: Valuable as the organization grows, but a scalable solution is ineffective if it does not meet business or security needs.
• Development methodologies: Relevant to implementation, but they do not define the organization’s fundamental security requirements.

• VLAN 10 for data
• VLAN 20 for voice

• A: Describes physical trunking or logical switch ports, not an SVI.
• B: An SVI can provide management access, but that is only one use—not the best description here.
• D: SVI use is not related to running out of physical ports.

• Set credit quotas for an account or individual virtual warehouses.
• Define monitoring intervals.
• Trigger actions when usage reaches thresholds, such as sending notifications or suspending a warehouse.
• Help control unexpected warehouse spending.

• Account Usage: Provides historical usage and billing data; it does not enforce credit limits.
• Warehouse Limit Parameter: Not the Snowflake object used for account-wide credit controls.
• Credit Consumption Tracker: Not a standard Snowflake object.

• Response and resolution time frames
• Availability or uptime requirements
• Performance targets
• Support obligations
• Penalties for failing to meet requirements

• SOW (Statement of Work): Defines the project’s scope, tasks, and deliverables.
• MOA (Memorandum of Agreement): Describes cooperation and responsibilities between parties.
• MOU (Memorandum of Understanding): Records a general mutual understanding, usually without detailed enforceable service targets.

• IaaS: você gerencia a VM e o sistema operacional.
• PaaS: o Azure gerencia a infraestrutura; você se concentra no aplicativo.