RAPS RAC-GS Exam Prep
Regulatory Affairs Certification (RAC) Global Scope (Page 10 )

• 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.

• Asynchronous inference is designed for applications that submit individual inference requests, place them in a queue, and retrieve results later. It is useful when requests may take a long time or when traffic is intermittent.
• Batch transform is designed specifically to run inference over an entire large dataset stored in Amazon S3 and produce an output dataset.

• Large dataset/offline processing ? Batch transform
• Large or slow individual requests processed later ? Asynchronous inference

• Advanced Persistent Threat (APT): A sustained, targeted attack campaign or attacker group—not a vulnerability.
• Trojan: Malware disguised as legitimate software.
• Stealthware: A general term for malware designed to avoid detection; it does not specifically mean an unknown vulnerability.

• 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.

• Labels control access and protection, not blanket exclusion.
• If the user has permission to open a labeled file—especially if the label allows authenticated users to view it—Copilot can use that file in a summary.
• If the label applies encryption and the user lacks the required usage rights, Copilot should not use the file or reveal its contents.
• Copilot honors the user’s existing permissions, so it should not expose labeled content to an unauthorized user.

• C — Some risks cannot be eliminated.

• D — Accepting residual risk does not imply recklessness.

• E — Most companies in this industry will say something similar.

• Sales revenue is affected because internal sales are recorded at the transfer price.
• Operating profit is affected because revenue changes while costs may remain unchanged.
• Return on investment (ROI) is affected because ROI depends on operating profit and the division’s investment.
• Cost of components purchased is not affected by the transfer price. These are costs incurred when buying components from external suppliers, not the internal price charged for the division’s output.

• Reconnaissance: Gathering information about the target.
• Weaponization: Creating or combining a malicious payload with a delivery method.
• Delivery: Sending the payload, such as through phishing.
• Exploitation: Triggering a vulnerability or weakness to gain execution or access.

• 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.

• The JSON files contain one billion items, so this is a big-data workload.
• PySpark uses Apache Spark’s distributed, parallel processing, allowing the data to be processed across multiple compute nodes.
• It can read and transform data directly from OneLake, helping minimize unnecessary data movement or duplication.
• A Fabric notebook can also support exploration and visualization, as well as Spark-based analytics and anomaly-detection workflows.

• Pandas is primarily in-memory and generally suited to smaller datasets. One billion records would be impractical on a typical single machine.
• A Power BI report with core visuals is appropriate for visualization and sharing, but it is not the best tool for large-scale transformation, parallel processing, or anomaly detection. It would normally consume prepared data rather than perform the entire workload.

• Information sources: Collect security-related data, such as network packets, system logs, audit records, or application events.
• Analysis: Examines the collected data to identify suspicious activity, attacks, or policy violations.
• Response: Takes or recommends action, such as generating alerts, logging the event, or supporting a protective response.

• Existing expected ROI: 15%
• New project ROI: 14%
• Cost of capital: 12%

• Project return = 14%
• Cost of capital = 12%
• It earns 2% more than the cost of capital, so it should increase shareholder value.

• 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.

• A business-hours greeting
• An after-hours greeting
• A holiday greeting

• Weekday evenings/nights
• Saturdays and Sundays

1. Auto attendant 1

1. Auto attendant 2

• Restrict a port to a defined number of MAC addresses
• Use statically assigned or “sticky” MAC addresses
• Shut down or restrict the port when violations occur

• Load balancer: Distributes application traffic; it does not protect switch MAC tables.
• IPS: May detect suspicious network activity, but is not the primary control for limiting switch MAC entries.
• NGFW: Filters traffic at the network boundary; it does not directly prevent MAC table flooding on access switches.

• Matching hashes: The software likely has not changed.
• Different hashes: The software was modified or corrupted.

• Encryption: Protects confidentiality by making data unreadable; it does not primarily detect changes.
• Baselines: Define an approved system or configuration state, but they are not the specific integrity mechanism here.
• Tokenization: Replaces sensitive data with substitute values.

• Each directory is a separate identity boundary.
• Managing multiple directories increases administrative overhead.
• Users and administrators may need separate identities or additional configuration across tenants.
• Resources in a subscription are associated with one Microsoft Entra tenant.

• Management groups for governance across subscriptions
• Separate subscriptions for divisions when appropriate
• Resource groups to organize resources
• Azure role-based access control (RBAC) to give each division’s administrator access only to their own resources

• Disable high concurrency: This changes session-sharing behavior but does not provide dedicated compute or true workload separation.
• Modify the number of executors: Adjusts resources within a Spark job; it does not isolate bronze and silver processes.
• Set the default environment: Controls libraries and runtime configuration, not compute isolation.

• Deterrent control: The signs warning people they may be filmed discourage unauthorized or malicious behavior. They may prevent incidents by influencing behavior, but their primary purpose is to deter.
• Detective control: The CCTV system monitors and records activity so security personnel can identify suspicious or unauthorized actions.

• Preventive: Blocks or prevents an incident, such as a lock or access-control system.
• Corrective: Fixes or restores systems after an incident.
• Directive: Tells people what they must do, typically through policies or procedures.
• Compensating: Provides an alternative control when the preferred control cannot be used.

• A — Consumption-based pricing: AWS generally uses a pay-as-you-go model. You pay for the resources you consume rather than purchasing hardware upfront or paying for unused capacity.
• C — Economies of scale: AWS purchases and operates infrastructure at a very large scale, allowing it to reduce costs and pass some savings to customers through lower service prices.

• Perpetual licenses: These involve paying once for permanent software ownership and are not a primary AWS Cloud economic benefit.
• AWS Enterprise Support at no additional cost: Enterprise Support has an additional charge.
• Bring-your-own-hardware model: AWS provides and manages the underlying cloud infrastructure; customers do not normally bring their own physical servers.

• Active-active routers: Provide redundant Internet connections/devices. Both can operate, so traffic can fail over or be load-balanced.
• Active-active firewalls: Avoid a single firewall becoming a failure point while maintaining security inspection.
• Load balancers: Distribute requests across multiple web servers. If one server fails, traffic can go to the other.
• Redundant power supplies: A server with separate power supplies should connect to independent power sources or circuits.
• UPS A and UPS B: Provide backup power and redundancy. Ideally, each power supply is connected to a different UPS.
• SONET ring: A ring topology provides alternate paths if a fiber link or segment fails.

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

• Security
• Availability
• Processing integrity
• Confidentiality
• Privacy

• Whether controls are suitably designed, and
• Whether they operated effectively over a period of time

CIMA P3 topics

• IT governance and systems strategy
• Systems development and implementation
• Change and project governance
• Strategic and business risk

• A — Plan for new systems: The committee should help identify and prioritise systems requirements and ensure planned systems support organisational needs.
• D — Consider competitive issues: New information systems may affect Y’s competitive position, service quality and efficiency. These strategic implications should be considered.
• E — Ensure the system meets company goals: This is a key governance responsibility. The committee should ensure the project remains aligned with Y’s objectives and delivers business value.

• B — Develop new systems: Detailed system development should be performed by IT specialists and project teams, not the steering committee.
• C — Manage the project: The project manager should handle day-to-day project management. The steering committee should provide oversight, challenge and key decisions, rather than manage daily activities.

• Sets a high initial price for a new product.
• Targets customers willing to pay more, often called early adopters.
• Gradually reduces the price to attract more price-sensitive customers as the product becomes less novel and competition increases.

• Penetration pricing: starts with a low price to gain market share quickly.
• Premium pricing: maintains a high price to communicate superior quality or status; it does not necessarily involve later price reductions.
• Loss leader pricing: sells one product at a very low price, sometimes below cost, to attract customers who may buy other products.

• terraform init is normally required first, especially for a new or changed working directory. It installs providers/modules and configures the backend.
• terraform plan previews the proposed changes.
• terraform apply applies those changes. It also creates a plan internally if you have not supplied a saved plan.

text 
terraform init 
terraform validate       # optional but recommended 
terraform plan 
terraform apply

• 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.

• CSIRT: A team that responds to and manages security incidents.
• CVSS: A scoring system for rating the severity of vulnerabilities.
• SOAR: A technology platform for automating and coordinating security operations and incident response.

• A: Concerns task scheduling and avoiding missed runs, not directly sizing the warehouse.
• B: The amount of data in a stream alone does not reliably determine compute needs; the SQL processing is what matters.
• D: A multi-cluster warehouse addresses concurrency, not the compute size needed for one task execution.

• Packet capture: Collects and analyzes network traffic; it does not describe the scan type.
• Privilege escalation: Attempts to gain higher permissions after obtaining access.
• System enumeration: Identifies systems, services, or resources, but is not specifically defined by the lack of credentials.
• Passive scan: Observes traffic without actively probing systems. A vulnerability scan is generally an active assessment.

• A — Technical review by business owner: A business owner may approve the business impact, but a technical review is normally performed by technical personnel.
• C — Cost-benefit analysis after implementation: Cost-benefit analysis should occur before implementation to support the approval decision.
• D — Business continuity testing: This can be appropriate for major changes, but it is primarily part of business continuity and disaster recovery planning—not a universal change-management activity.

1. Create Workspace2 with Lakehouse2 — F
2. Migrate the Employee table to Lakehouse2 — E
3. Assign the data engineer the Contributor role for Workspace1 — D

Why

• Sharing Lakehouse1 would not provide the required isolation.
• Viewer access would not allow writing to Customer.
• Giving Contributor access to Workspace2 would expose the sensitive table.

• Escape to host: A virtualization attack where code escapes a guest VM and accesses the host system. Nothing in the scenario mentions virtualization.
• Browser extension: Can redirect or manipulate web-browser traffic, but not normally database-server traffic.
• Valid accounts: Describes using stolen or compromised credentials, not redirecting network traffic.
• Process injection: Injecting malicious code into a legitimate database or networking process could allow an attacker to alter how that process handles outgoing traffic.

• Access List: controls whether a client is allowed or denied.
• Connect List: controls which wireless networks/APs a station may connect to.

• Insert is used when you are creating a new record. It saves the record to the table and then leaves the form.
• Update is used when editing an existing record. It saves the modifications and then leaves the form.

• Standardize which services users can deploy
• Apply governance and access controls
• Manage approved product versions
• Give users self-service access to authorized resources

• AWS Control Tower: Sets up and governs a multi-account AWS environment.
• AWS Cloud Map: Provides service discovery for applications.
• AWS Clean Rooms: Enables privacy-preserving collaboration on data analysis.

• Treatment one – easier to prepare: Convenience for the accounting team is not the main objective of financial reporting.
• Treatment two – fair representation: This is the correct choice because financial statements must faithfully represent the underlying transaction and its economic substance.
• Treatment three – maximises profit: Accounting policies must not be selected simply to manipulate or inflate reported profit.
• Treatment four – easier to understand: Understandability is important, but it cannot justify presenting information that is less faithfully represented.

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

• Virus signatures: Primarily associated with antivirus or antimalware tools.
• Security agent deployment: Usually handled by endpoint-management or endpoint-security platforms.
• Vulnerability scanning: Performed by vulnerability-assessment tools, although a SIEM may ingest their results.

Step 1: Calculate the rights issue price

Step 2: Calculate the number of new shares

Step 3: Calculate the value after the issue and project

• Rights issue proceeds: $21.6m
• Project NPV: $5m

Step 4: Calculate the theoretical ex-rights price

• Azure DevOps Analytics views are accessed through the Power BI Azure DevOps (Boards only) connector.
• This connector authenticates directly to Azure DevOps Services and lets you select an Analytics view.
• Analytics views allow filtering and shaping data in the cloud before Power BI loads it.
• Azure DevOps Server (Boards only) is for an on-premises Azure DevOps Server instance, not Azure DevOps cloud.
• A generic OData Feed connection can access OData endpoints, but it is not the purpose-built connector for Azure DevOps Analytics views.
• “OData queries” describes the underlying technology or query approach, not the most appropriate Azure DevOps connector choice here.

• Transport and handling
• Storage and warehousing
• Refrigeration
• Shelf-stacking or replenishment
• Other costs directly attributable to product P

• A: Not expanding would increase its dependence.
• B: More business from the same corporation would make dependence worse.
• D: Passing work to other minority businesses does not solve its own dependence.
• E: The passage does not suggest that it can force or influence the corporation to give work to others.

• The S3 bucket as an origin for static content
• The Application Load Balancer (ALB) as an origin for dynamic content
• An Amazon Route 53 alias record pointing the application domain to CloudFront

Why this works

• Static data: CloudFront caches objects from S3 at edge locations, reducing latency for users worldwide.
• Dynamic data: CloudFront forwards requests that require application processing to the ALB. It can also maintain persistent connections and use the AWS global edge network to improve delivery performance.
• One domain: CloudFront behaviors can route different path patterns to different origins—for example, /static/* to S3 and other paths to the ALB.

Why the other options are incorrect

• Global Accelerator is designed primarily for accelerating traffic to applications with endpoints such as ALBs, not for caching S3 content.
• Using separate domains or splitting static and dynamic traffic adds unnecessary complexity.
• CloudFront already provides the required global edge distribution and caching, so combining it with Global Accelerator is unnecessary here.

• A — If there is no demand, there should be no production.

• B — Not all sales equal profit.

• C — Stocking up on inventory is bad for business.

• D — All costs, except materials, are considered fixed.

• E — Departments should operate at full capacity regardless of bottlenecks.

• File is shared externally ? Access level

• File is labeled “Internal only” ? Sensitivity label

Correct sequence

1. Merge Sales_Region with Sales_Manager using an inner join

1. Merge Region_Manager with Manager using an inner join

1. Merge Sales_Region and Region_Manager using a right join as a new query