Training Materials Part2
F.4.2: Video Tutorial Scripts
Tutorial Script Format
Each video tutorial follows this standardized format:
- Duration: 3-5 minutes
- Format: Screen recording with voice narration
- Resolution: 1920x1080 (1080p)
- Frame Rate: 30 fps
- Audio: Clear narration, background music optional (low volume)
- Captions: Auto-generated + manual review for accuracy
- Platform: Hosted on secure training portal with completion tracking
Video Tutorial #1: Getting Started with BIO-QMS
Title: "Welcome to BIO-QMS: Your First Login and Dashboard Tour" Duration: 4:00 Target Audience: All new users Prerequisites: User account provisioned by IT Administrator
Script
[00:00-00:15] INTRO - Title Screen
SCREEN: BIO-QMS logo with title "Getting Started with BIO-QMS"
NARRATION: "Welcome to BIO-QMS, the regulated Quality Management System
designed for pharmaceutical and biotech companies. In this video,
you'll learn how to log in, navigate the dashboard, and access your assigned tasks."
[00:15-00:45] SEGMENT 1 - First Login
SCREEN: Browser at https://bio-qms.example.com/login
NARRATION: "Open your web browser and navigate to the BIO-QMS login page.
You'll receive your username and temporary password from your IT Administrator.
Enter your credentials and click 'Sign In'."
ACTION: Type username "jane.smith@pharmatech.com", enter password, click Sign In.
SCREEN: Password reset prompt appears.
NARRATION: "On your first login, you'll be prompted to change your password.
Choose a strong password with at least 12 characters, including uppercase,
lowercase, numbers, and symbols. This ensures your account remains secure
and compliant with 21 CFR Part 11 requirements."
ACTION: Enter new password, confirm, click "Update Password".
[00:45-01:30] SEGMENT 2 - Dashboard Overview
SCREEN: Dashboard home page with widgets visible.
NARRATION: "Welcome to your BIO-QMS dashboard. The dashboard provides
a real-time view of your quality tasks and system status. At the top,
you'll see the main navigation menu with modules: CAPAs, Deviations,
Documents, Audits, Training, and Reports."
ACTION: Hover over each menu item to highlight.
NARRATION: "In the center, you'll see widgets displaying your assigned tasks.
The 'My Tasks' widget shows all open items requiring your action.
The 'Recent Activity' widget shows recent updates across the system.
And the 'Training Status' widget displays your required training modules
and completion progress."
ACTION: Click on each widget title to expand/collapse.
[01:30-02:15] SEGMENT 3 - My Tasks Widget
SCREEN: My Tasks widget expanded, showing 5 open tasks.
NARRATION: "Let's explore the 'My Tasks' widget. Here, you'll see all
quality records assigned to you, including CAPAs, deviations, and document
reviews. Each task displays its priority, due date, and current status."
ACTION: Hover over a High priority CAPA task.
NARRATION: "Tasks are color-coded by priority: Red for Critical or High priority,
Yellow for Medium, and Green for Low. Overdue tasks are marked with a red
exclamation icon. Click on any task to open the full record."
ACTION: Click on CAPA-2024-0042.
[02:15-03:00] SEGMENT 4 - Navigating a Record
SCREEN: CAPA-2024-0042 record details page.
NARRATION: "You're now viewing the full CAPA record. At the top, you'll see
the CAPA ID, title, and current workflow status. The tabs below organize
information into sections: Details, Investigation, Actions, Effectiveness,
and Audit Trail."
ACTION: Click through each tab to show content.
NARRATION: "The 'Actions' tab shows corrective actions assigned to you.
To update progress, click 'Update Status', enter your notes, and attach
any supporting evidence such as revised SOPs or training records.
When complete, mark the action as 'Done' and click 'Save'."
ACTION: Click "Update Status", type progress note, attach file, select "Done", click Save.
[03:00-03:45] SEGMENT 5 - Customizing Your Dashboard
SCREEN: Back to dashboard, click "Customize Dashboard" button.
NARRATION: "You can personalize your dashboard by adding, removing, or
rearranging widgets. Click the 'Customize Dashboard' button in the top right."
ACTION: Click "Customize Dashboard", drag-and-drop widgets to reorder.
NARRATION: "Drag and drop widgets to reorder them. To add a new widget,
click 'Add Widget' and choose from available options such as 'Open Deviations',
'Pending Approvals', or 'Audit Schedule'. Remove widgets by clicking the
'X' in the corner. Your layout is saved automatically."
ACTION: Add "Open Deviations" widget, remove "Recent Activity", click "Done".
[03:45-04:00] CLOSING
SCREEN: Dashboard with customized layout.
NARRATION: "Congratulations! You've completed your first login, explored
the dashboard, and learned how to navigate quality records. Next, complete
your role-specific training modules to access advanced features.
Thank you for watching!"
SCREEN: End screen with "Next: CAPA Workflow Tutorial" button.
Assessment Questions:
- What is the minimum password length for BIO-QMS accounts? (Answer: 12 characters)
- Where can you view all tasks assigned to you? (Answer: "My Tasks" dashboard widget)
- How are high-priority tasks visually identified? (Answer: Red color coding)
- Can you customize your dashboard layout? (Answer: Yes, via "Customize Dashboard")
Video Tutorial #2: CAPA Workflow from Creation to Closure
Title: "Mastering CAPA Management: From Incident to Effectiveness" Duration: 5:00 Target Audience: QA Specialists, QA Managers Prerequisites: Module QAS-101 or QAM-101 completed
Script
[00:00-00:15] INTRO
SCREEN: Title "CAPA Workflow Tutorial"
NARRATION: "CAPA—Corrective and Preventive Action—is the cornerstone
of continuous improvement in GMP environments. In this tutorial,
you'll learn how to create a CAPA, conduct root cause analysis,
assign corrective actions, and verify effectiveness."
[00:15-01:00] SEGMENT 1 - Creating a CAPA
SCREEN: Navigate to CAPAs menu > "Create CAPA" button.
NARRATION: "CAPAs can be created from deviations, audit findings,
customer complaints, or proactively to address potential risks.
To create a CAPA, click the 'CAPAs' menu and then 'Create CAPA'."
ACTION: Click CAPAs > Create CAPA.
SCREEN: CAPA creation form.
NARRATION: "You'll see the CAPA creation form. Start by selecting
the CAPA type: Corrective (to fix an existing problem) or Preventive
(to prevent a potential issue). Next, choose the priority: Critical,
High, Medium, or Low. Critical CAPAs address immediate patient safety
or product quality risks."
ACTION: Select "Corrective", Priority "High".
NARRATION: "Enter a clear, descriptive title and provide detailed
information about the issue. If this CAPA is linked to a deviation
or audit finding, use the 'Link Related Record' button to establish
the connection. Finally, assign the CAPA to a QA Specialist or Manager
for investigation."
ACTION: Enter title "Incorrect temperature recording in cold room",
link to DEV-2024-0089, assign to "John Doe", click "Create".
[01:00-02:15] SEGMENT 2 - Root Cause Analysis
SCREEN: CAPA-2024-0055 Investigation tab.
NARRATION: "Now that the CAPA is created, the assigned investigator
will conduct a root cause analysis. Open the CAPA record and navigate
to the 'Investigation' tab. BIO-QMS provides built-in tools for
5-Why analysis and Fishbone diagrams."
ACTION: Click "Investigation" tab, click "Start 5-Why Analysis".
SCREEN: 5-Why analysis tool interface.
NARRATION: "The 5-Why technique asks 'Why did this happen?' repeatedly
to drill down to the underlying cause. Let's walk through an example.
The problem: Incorrect temperature was recorded. Why? The technician
read the wrong thermometer. Why? Labels on thermometers were faded.
Why? Preventive maintenance was not performed. Why? PM schedule was
not followed. Why? No automated alerts for overdue PM tasks."
ACTION: Enter each "Why" and answer in the tool.
NARRATION: "The root cause is: Lack of automated preventive maintenance
alerts. Document your findings in the investigation summary and save."
ACTION: Enter summary text, click "Save Investigation".
[02:15-03:30] SEGMENT 3 - Assigning Corrective Actions
SCREEN: CAPA Actions tab.
NARRATION: "With the root cause identified, it's time to assign corrective
actions. Navigate to the 'Actions' tab and click 'Add Action'.
Each action should directly address the root cause."
ACTION: Click "Actions" tab > "Add Action".
SCREEN: Add Action form.
NARRATION: "For our thermometer labeling issue, we'll create two actions.
First, an immediate corrective action: Re-label all thermometers in
cold storage. Assign this to the Maintenance team with a due date of
7 days. Second, a systemic preventive action: Implement automated PM
alerts in the maintenance system. Assign this to IT with a 30-day due date."
ACTION: Create action "Re-label thermometers", assign to Maintenance,
due in 7 days. Create action "Implement PM alerts", assign to IT, due in 30 days.
NARRATION: "Each assignee will receive a notification and the action
will appear in their 'My Tasks' dashboard. As actions are completed,
assignees will update status and attach evidence such as photos of
re-labeled equipment or screenshots of the new alert system."
ACTION: Show task notification email example.
[03:30-04:30] SEGMENT 4 - Effectiveness Verification
SCREEN: CAPA Effectiveness tab.
NARRATION: "Corrective actions are only effective if they produce
sustained improvement. After actions are complete, conduct an effectiveness
check. Navigate to the 'Effectiveness' tab and click 'Schedule Effectiveness Check'."
ACTION: Click "Effectiveness" tab > "Schedule Effectiveness Check".
SCREEN: Effectiveness check form.
NARRATION: "Effectiveness checks should be scheduled after a monitoring
period, typically 30 to 90 days. This allows time to verify that the
problem has not recurred. For our thermometer example, we'll schedule
a check for 60 days after action completion to review temperature
recording accuracy and PM compliance."
ACTION: Set check date to 60 days, assign to QA Manager, enter check criteria.
NARRATION: "When the check date arrives, the assigned QA Manager will
review temperature logs, interview staff, and inspect equipment. If
the issue has not recurred and PM alerts are functioning, the effectiveness
check is marked as 'Passed'. If the problem persists, additional actions
are required."
ACTION: Show example of passed effectiveness check with supporting data.
[04:30-05:00] SEGMENT 5 - CAPA Closure
SCREEN: CAPA summary view with all actions complete and effectiveness passed.
NARRATION: "Once all corrective actions are complete and the effectiveness
check has passed, the CAPA is ready for closure. Only QA Managers or
designated approvers can close CAPAs. Click 'Request Closure' to submit
for approval."
ACTION: Click "Request Closure" button.
SCREEN: QA Manager approval screen.
NARRATION: "The QA Manager reviews the investigation, actions, and
effectiveness data. If satisfied, they approve the closure by entering
their electronic signature. The CAPA status changes to 'Closed', and
the record is archived in the system with a complete audit trail."
ACTION: QA Manager clicks "Approve Closure", enters password for e-signature, CAPA closes.
SCREEN: Closed CAPA with "Closed" badge.
NARRATION: "Congratulations! You've successfully completed a CAPA from
creation to closure. This process ensures continuous improvement and
regulatory compliance. Thank you for watching!"
Assessment Questions:
- What are the two types of CAPAs? (Answer: Corrective and Preventive)
- What technique asks "Why?" repeatedly to find root causes? (Answer: 5-Why Analysis)
- When should effectiveness checks be scheduled? (Answer: After a monitoring period, typically 30-90 days)
- Who can approve CAPA closures? (Answer: QA Manager or designated approvers)
(Continuing with Video Tutorials #3-#5 and remaining sections...)