This document summarizes the features and benefits of the SBS Q-Med Database software for managing quality systems in medical device and FDA-regulated industries. The software allows users to track nonconformances, corrective and preventive actions, audits, meetings, and customer satisfaction surveys. It provides templates for documentation, electronic signatures, and reporting functionality to analyze data. The software is intended to help users comply with quality standards like ISO 13485, 21 CFR 820 and improve processes through effective management of quality records and metrics.
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CAPA for FDA regulated industries
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The SBS Q-Med Database
Introduction
Features and Benefits
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Fueling Small Business Efficiency
Corrective and Preventive Action software for FDA regulated industries
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Background
Medical Device / FDA Quality standards require many things including:
Corrective Actions
Preventive Actions
Nonconformance dispositions
Internal Audits
Management reviews
Continual Improvement
Customer satisfaction assessments
The SBS Q-Med database was created to ease the complexity of compliance
to quality management system standards:
ISO 13485: Medical devices-Quality management systems-Requirements for
regulatory purposes
Quality System Regulation 21 CFR 820
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Q-Med Database Key Features
Nonconformance Tracking
Escalate a Nonconformance to a Corrective Action
Corrective Actions (CA)
Safety, Supplier, Internal Audit CARs
With Validation and Verification
Approvals require electronic signatures
Preventive Actions (PA)
Audit management
Record audit findings
Manage Audit Schedules
Escalate to a Corrective Action or Preventive Action
Meeting management
Project management
Customer satisfaction surveys
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Q-Med Modules
Non-Conformance
(NCR)
Corrective
Actions (CAR)
Preventive
Actions (PAR)
Customer
Complaint
Audits
Surveys
Quality Control
/ Inspection
Meeting
Manager
Improvement
Projects
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User Interface
Username and Password protected
Efficient menu listing / “Switchboard”
Data entry in simple forms
A rich set of configurable reports
Email reports with a single click
Easily export data to Excel or Word
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General Features
Utilizes the 8D Corrective Action Process
Security with password access and control of privileges
CFR21 part 11 compliant security, Electronic signatures, audit trails
Link electronic documents for a paperless system
Supports single and Multi-user network environments
Built on Microsoft Access 2007
Compatible with Microsoft Access 2010 and 2013
No need to purchase Access if you do not have it
A free run-time version of Access is available from the Microsoft
website
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Benefits
Complies with requirements of
21 CFR 820
ISO 13485
ISO 9001:2008
CFR 21 part 11
Provides a concise, electronic record of historical events, actions, and
improvement
No paper to get lost
Efficiently maintains quality records for
Internal audits
Corrective Action results
Preventive Action results
Management review or MRB meetings
Nonconformances
Customer satisfaction surveys
Improve product reliability and process performance
Improve Customer Satisfaction
Rapidly report results to Customers
Email report directly from the database
Stay on top of key Customer issues
Rebuild customer confidence when things go wrong
Analyze Customer perceptions over time
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Benefits
Efficient and cost effective
Simple, low cost solution
No additional software to purchase
No annual maintenance fees
Concurrent user licensing – not CPU based
Minimal training is required
Saves time and improves efficiency
Reports and analysis
Managers get immediate answers
How many CA/PA Requests are open and why?
How long are CA/PA Requests open?
Email reminders for open actions
Develop agendas for meetings
Easy to identify and manage open action items
Reduce cycle time to implement corrective actions
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Login Screen
The login process limits access to the database features
The Demo version includes dummy data and employees
administrator has full Database privileges
For the demo database,
– Username: administrator
– Password: Aa777777
– Note: username and password are case sensitive
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The 8D Problem Solving Process
D0 • Plan
D1 • Build a team
D2 • Define the problem
D3 • Contain the problem
D4 • Define and verify the root cause(s)
D5 • Determine and verify the permanent corrective actions
D6 • Implement and verify the permanent solution
D7 • Prevent recurrence
D8 • Congratulate the team!
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CAPA Status (Process flow)
NEW CAR / PAR
Containment
Actions Approved
Proposed
Corrective Actions
Approved
CA have been
completed and
validated
Waiting
Containment
Containment
Approved
Corrective
Action
Approved
CLOSED
CAR / PAR is on
HOLD
CAR / PAR has
been CANCELLED
HOLD
CANCELLED
Process CAR / PAR Status
Exceptions Status
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Corrective Action Form – Root Cause Analysis
Document multiple root causes for a
single CAR including Primary, Escape,
and Contributing root causes
Ask why? Enough times to
determine effective root causes
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Corrective Action Form – Corrective Actions
Electronic signature required
to approve Root
Cause/Corrective Action Plan
Electronic signature
required to approve
validation
Establish clear,
quantifiable
acceptance criteria
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Preventive Actions
PAR Form
Reports and analysis
Measure effectiveness
For want of a nail, the shoe was lost,
For want of the shoe, the horse was lost,
For want of the horse, the rider was lost,
For want of the rider, the battle was lost,
For want of the battle, the kingdom was lost,
And all for the want of a horseshoe nail!
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Failure Analysis
Produce professional Failure
Analysis reports
Assign multiple root causes –
later, analyze by root cause
Describe the failure analysis
technique and results
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Disposition Document what is to be done
with the material: Release,
Rework, Downgrade, or Scrap
Produce a concise
nonconformance report
Escalate any Non-
conformance to a CAR
with a click of a button
Electronic Signature
required to approve
Material Disposition
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Background
Great for MRB and Quality Management System Review meetings
Document a meeting
Who attended
What was the agenda?
What was discussed?
What were the resulting actions to be taken?
Are the actions complete?
Were the actions effective?
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Simple Survey Features
Easily create custom surveys
Simple, intuitive interface
Print out or e-mail a professional looking survey directly
from the program
Ask different types of questions
True or False / Yes or No
Rating (on a scale of one to ten)
Text response (let the customer provide feedback in his own
words)
Create an efficient quality record
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Simple Survey Features
Customer Satisfaction
Directly quantify customer satisfaction
Monitor Customer perceptions
Analyze trends with grafts and reports
Vendor qualification surveys
Measure vendor suitability
Monitor vendor improvement
Employee opinion polls
Measure job satisfaction
Solicit continual improvement ideas
Measure and track long term results print
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Create a Survey
Simple, efficient interface
Data entry in simple forms
Enter General
Information
Organize the
survey into topics
List all Survey
questions & define
types
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Creating Surveys
Enter general survey information
Create a survey Category (i.e. Customer Service, General, Engineering Support, etc.)
Create a question and establish the order in which it will appear on the survey
Select the question type.
Yes/no and true/false questions are rated as either 0 or 10
Text response questions have no score
Rating types receive a number rating from 1 to 10 with 1 being the lowest or worst level.
If the question was yes/no or true/false, you must determine if a positive answer
(yes or true ) carries the maximum score.
Check the check box labeled "PositiveIsTen" if a positive answer receives the maximum
score.
Leave the "PositiveIsTen" check box unchecked if a positive answer should receive the
minimum score.
Each question may be weighted differently (not all questions were created equal).
The "Weight" field is used to score each question where Score = Rating * weight.
The user must determine appropriate waiting factors.
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Demo Database Installation
The demo database is a stand-alone access database with all the features of
the standard product.
To install the program:
Download the demo database from www.SundayBizSys.com
Save or copy the Q-Med Database.accde file to a designated folder on your
Network File Server
Ensure all Workstations have
Microsoft Access or the free Runtime version of Microsoft Access
Read and write privileges to the designated folder on the Network File Server
Note: The above graphic is for stand alone Access databases - SQL configurations are different
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Purchased Product Installation
The purchased product has 2 parts:
Microsoft SQL back end
Microsoft Access front end
The Microsoft Access front end connects to the SQL back end through
standard ODBC links from each user computer.
The Customer must provide the SQL server and the database
administration. SBS will provide the SQL files for installation and the Q-Med
front end.
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Summary
The SBS Q-Med Database is a cost effective tool to
Ensure effective compliance with Quality standards
ISO 13485
21 CFR 820 - Quality System Regulation
21 CFR Part 11
ISO 9001:2008
Manage meetings
Monitor Customer perceptions
Maintain paperless quality records
Analyze performance and develop improvement strategies
Save time and effort
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About SBS
Sunday Business Systems is engaged in software sales and consulting
services.
Sells affordable and efficient software solutions to implement Quality
management systems:
Document Control
Corrective and Preventive Actions
Audit Management
Employee Training
Control of calibrated equipment
Vendor Management
SPC
Continual improvement
Provides Training and instruction
Provides custom software solutions
Modify and existing program
Build a complete custom solution for your specific business processes
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