RAPS RAC-GS Exam Prep
Regulatory Affairs Certification (RAC) Global Scope (Page 5 )

• Product recall: Premature before confirming a violation or assessing risk.
• Notify the regulatory authority: May be required later, especially if the discrepancy affects safety or compliance, but first investigate and verify the facts.
• Inform production: Not the initial regulatory assessment step; production may become involved if a packaging or manufacturing error is identified.

• 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.

• 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.

• Azure Cosmos DB is a globally distributed NoSQL database service. It stores and retrieves application data, but it does not provide the complete environment for building, testing, and deploying predictive analytics models.
• Azure Machine Learning is the appropriate service for this requirement. It supports creating experiments, training and testing models, and deploying them for predictions.
• Azure Machine Learning Studio provides the browser-based interface for these tasks.

• Incident and problem management
• Change management
• Service-level management
• Configuration management
• Continual improvement

• Kanban: A workflow and task-visualization method; useful within service teams but not a complete service-management framework.
• Lean Six Sigma: Focuses on reducing waste and process variation; broader process-improvement methodology.
• ITSM: The overall discipline of managing IT services, not a specific framework or process model.

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.

• Storage usage of files stored in Microsoft Teams: SharePoint site usage report

• Number of active users per team: Microsoft Teams usage report

1. SharePoint site usage report
2. Microsoft Teams usage report

• If the attachment is safe, it is released to the user.
• If malware is detected, the attachment is blocked or removed according to the policy.
• This reduces delivery delays without disabling malware scanning.

• Replace removes the original attachment and replaces it with a text file explaining that it was blocked. It does not primarily optimize delivery time.
• Block and Enable redirect blocks messages with suspicious attachments and can redirect them for review; it does not provide the required faster delivery experience.
• Monitor and Enable redirect is for observation and does not reliably block malicious attachments.

• A — Windows 11 with Azure CLI installed: Yes

• D — Chrome OS using Azure Cloud Shell: Yes

• E — Windows 10 with the Azure PowerShell module installed: Yes

• B — Linux with only Azure CLI: No, because the option does not state that PowerShell is installed.
• C — macOS with PowerShell Core only: No, because it does not state that Azure PowerShell modules or Azure CLI are installed.

• Unsafe images: Requires image/content moderation before the image is processed.
• Hidden instructions embedded in images: These are indirect prompt injections contained in untrusted image content or extracted text, not necessarily in the user’s typed prompt.

• Virtual introductions: Team members share their role, experience, location, and working preferences.
• Online icebreakers: Short, informal activities such as “two truths and a lie.”
• Virtual coffee chats: Pair team members for informal, non-project conversations.
• Collaborative problem-solving: The team works together on an online puzzle or scenario.
• Retrospectives: The team discusses what went well, what did not, and how to improve.
• Working-agreement sessions: The team agrees on response times, meeting etiquette, communication channels, and handoffs.
• Recognition sessions: Members acknowledge one another’s contributions.
• Remote workshops: Teams jointly create plans, diagrams, or schedules using collaboration tools.

• 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.

Why A is the best fit

Why the other options are weaker

• B — Create alerts in Dynamics 365 Finance: Alerts notify users about changes; they do not calculate tax.
• C — Implement the Common Data Model: CDM standardizes data structures but does not provide tax-calculation logic.
• D — Run a Power BI report: Power BI is primarily for analysis and reporting. A report might display tax rates, but it would not normally calculate and apply tax to sales orders operationally.
• E — Write scripts and code: This could work, but it is less aligned with the requirement for a quick, cost-effective implementation because custom development requires more time and maintenance.

• B — Both inner and outer classes can be declared as with sharing.

• C — Inner classes do not inherit sharing settings from the container class.

apex 
public with sharing class OuterClass { 
    public with sharing class InnerClass { 
        // Explicitly uses sharing rules 
    } 
}

• B — The most significant risks are held by SQ.

• C — SQ should recognise the cars as inventory.

• F — SQ recognises revenue when LM sells a car to a third party.

• A: LM does not hold the most significant risks.
• D: LM does not recognise the cars as inventory.
• E: SQ should not recognise revenue when cars are merely delivered to LM.

• Undefined or blank values
• Relationship matching problems
• Duplicate or conflicting keys
• Errors when querying the model

• Normalize all values to upper- or lowercase in the source query or Power Query.
• Add an index or surrogate key when values that differ only by case must remain distinct.

• 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.

• Authentication: Verifies who the user is.
• Authorization: Determines what the authenticated user is allowed to access.
• Accounting: Records login activity and resource usage.

• CIA: Confidentiality, integrity, and availability—the core security objectives.
• ACL: Access Control List; rules that permit or deny traffic or access.
• PEM: A format and standard commonly associated with encoded certificates and keys.

• Install unauthorized or unapproved applications
• Access system areas normally restricted
• Add features unavailable in the default software
• Modify the device’s operating system

• SQL injection (SQLi): Attacks databases by inserting malicious SQL commands.
• Cross-site scripting (XSS): Injects malicious scripts into web pages viewed by users.
• Sideloading: Installs an application from outside the official app store, but it does not necessarily remove the phone’s operating-system restrictions.

• D — Managers focus on keeping costs low in the short term to maximise profits.

• E — Managers are given incentives to meet or undercut budgets.

• F — Managers delegate responsibility simply to reduce their workload.

xml 
<apex:page> 
    <apex:stylesheet value="{!URLFOR($Resource.MyStyles, 'styles/main.css')}" /> 
</apex:page>

• <apex:includeScript> is for JavaScript.
• <apex:includeStyle> is not a valid Visualforce component.
• <apex:require> is not the Visualforce tag used to load CSS.

• File is shared externally ? Access level

• File is labeled “Internal only” ? Sensitivity label

• Case Assignment Rules normalmente são avaliadas quando o caso é criado. Elas podem ser executadas novamente em uma edição somente se o usuário marcar “Assign using active assignment rules”; isso não acontece automaticamente apenas porque o caso foi fechado.
• Portanto, criar uma regra de atribuição não corrige os centenas de casos já fechados e não garante, por si só, que um caso será transferido antes de ser fechado.

• B — Usar uma ferramenta de dados: corrige os registros históricos já existentes, atualizando o Owner.
• D — Criar uma regra de validação: impede que um caso seja fechado enquanto ainda pertence a uma fila. Exemplo conceitual: se Status = Closed e o proprietário for uma fila, bloquear o salvamento.

• Packet loss
• Latency
• Jitter
• Call quality by user, device, network, location, or building

• Teams Usage Report: Shows adoption and usage statistics, not detailed call-quality metrics.
• Teams Device Usage Report: Reports which devices are being used and how, but does not provide detailed packet-loss analysis.
• Microsoft Network Testing Companion: Helps assess network readiness before deployment, but it is not the primary tool for analyzing packet loss from actual Teams calls.

• Lead investigator: Coordinates the investigation and directs the response.
• Information security representative: Provides security expertise and helps assess the incident.
• Technical representative: Preserves system evidence, takes forensic backups, and supports technical analysis.
• Legal representative: Advises on legal, regulatory, privacy, and evidence-handling requirements.

• Due diligence: Researching and evaluating a third party before entering or continuing a business relationship.
• Internal audit: Evaluates controls within the organization itself.
• Penetration testing: Actively tests systems for exploitable vulnerabilities.
• Attestation: A formal statement or report—such as a SOC 2 report—provided by an independent party about an organization’s controls.

Manager role

DAX 
Country[Manager] = USERPRINCIPALNAME()

• Sales
• Human Resources

CFO role

• See sales for all countries
• See no Human Resources data

• Do not restrict the Country table or Sales table.
• Apply a filter to Human Resources that always returns false, such as:

DAX 
FALSE()

• Warehouse size: Larger warehouses use more credits per unit of time than smaller ones.
• Number of clusters: A multi-cluster warehouse can run multiple clusters, and each active cluster consumes credits. Therefore, increasing the maximum or active cluster count can increase consumption.

• Number of users: More users may cause more workload, but users themselves do not consume credits.
• Amount of data processed: Snowflake warehouses are not charged directly by the amount of data scanned. However, processing more data may cause the warehouse to run longer, indirectly increasing credits.

• Row counts
• Minimum and maximum values for columns
• Distinct-value information
• Other characteristics used for optimization

• Defender for Servers is the Defender for Cloud plan that protects Azure VMs and generates security alerts that can be reviewed in Defender for Cloud.
• Azure Diagnostics extension collects guest OS monitoring data, but it does not onboard VMs to Defender for Cloud or provide Defender security alerts.
• Data connectors are used for Sentinel integrations.
• Azure Storage Analytics and workflow automation do not provide VM protection.

1. Wireless AP

1. Router

1. Firewall

1. Device placement

• Physical: Protects facilities or equipment, such as locks and security cameras.
• Technical: Uses technology, such as firewalls, encryption, or access controls.
• Operational: Covers day-to-day actions and processes, such as training, backups, or incident response.
• Managerial: Includes policies, standards, risk assessments, and procedures.

1. Clear principles and boundaries — Employees have freedom, but decisions must remain within clear organizational values, policies and limits.
2. High degree of freedom — Managers are trusted to make decisions rather than seeking continual approval from senior management.
3. Frontline customer responsibility — Customer-facing managers should be empowered to manage customer relationships and respond quickly to needs.
4. Transparent and ethical information — Information should be openly available and used honestly, supporting trust and informed decision-making.

• Run the backup with WITH CHECKSUM
• Store the backup on an SMB network share

sql 
BACKUP DATABASE DB1 
TO DISK = '\\FileServer\SqlBackups\DB1_full.bak' 
WITH CHECKSUM;

• DMS does not create the SQL Server backups for you.
• You must provide a valid full database backup.
• You must continue taking transaction log backups while the source database remains online.
• The full backup and subsequent log backups must be available in the SMB share that DMS can access.
• WITH CHECKSUM enables backup checksum validation, helping detect backup corruption.

• Due diligence: Investigating and evaluating a third party before entering into or continuing a business relationship.
• Attestation: An independent party provides assurance about an organization’s claims or controls. A SOC 2 examination is an example of an attestation engagement, but the analyst requesting and reviewing the report is performing due diligence.
• Internal audit: Reviews the organization’s own internal controls.
• Penetration testing: Actively tests systems for exploitable vulnerabilities.

• Root path cost
• Port priority
• Port ID

text 
interface GigabitEthernet0/1 
 spanning-tree vlan 10 port-priority 64

• Interface number: Helps form the port ID but is not normally configured as the preference value.
• VLAN priority: Not used to select a preferred forwarding interface.
• Hello time: Controls how often BPDUs are sent; it does not select a preferred port.

• PC A: 192.168.1.10/24
• PC B: 192.168.2.10/24

• Both PCs have a correct default gateway
• A router or Layer 3 switch connects the subnets
• Routing and firewall rules allow the traffic

• Vulnerability scanner: Identifies technical weaknesses in systems, applications, or devices.
• Penetration test: Simulates attacks to determine whether vulnerabilities can be exploited.
• SCAP (Security Content Automation Protocol): Uses standardized formats and protocols for automated vulnerability, configuration, and compliance checks.
• Illumination tool: Maps and analyzes broader supply-chain exposure and third-party risk.

• Creating and training machine-learning models
• Testing and evaluating models
• Deploying models as usable endpoints

• A — Use getRecordTypeInfosByDeveloperName()

apex 
  Id rtId = Schema.SObjectType.Account 
      .getRecordTypeInfosByDeveloperName() 
      .get('Business_Account') 
      .getRecordTypeId();

• C — Query the RecordType object

apex 
  RecordType rt = [ 
      SELECT Id 
      FROM RecordType 
      WHERE SObjectType = 'Account' 
      AND Name = 'Business Account' 
      LIMIT 1 
  ];

• B: An outbound SOAP call is unnecessary and inefficient.
• D: Hardcoding an ID is not dynamic, and IDs can differ between orgs.

1. System prompts can authorize users — No

1. System prompts can reduce TPM consumption — Yes, with qualification

1. System prompts guide generative AI behavior — Yes

• Match found: ServiceNow updates the existing target record.
• No match found: ServiceNow normally creates a new target record.
• No Transform Map is created or deleted based on whether a match is found.

• A. Adjust resolution: Incorrect because an incompatible resolution usually causes no display, distortion, or an unsupported-mode message—not intermittent flickering.
• B. Swap the HDMI cable: Correct. Replacing the common, easily tested component is the appropriate troubleshooting step.
• C. Replace the projector: Incorrect because the issue also occurs with a monitor.
• D. Configure refresh rate: A mismatched refresh rate can cause visual problems, but the repeated flicker across displays points more strongly to the cable.

• 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.

• To identify the number of errors: select Column quality. It shows the percentage and count of Valid, Error, and Empty values for each column.
• To resolve errors: use the appropriate error transformation:

1. Yes — One account can manage multiple subscriptions

1. No — You cannot merge two subscriptions into one

1. Yes — A resource belongs to only one subscription