Qualityze CAPA Management Solution is designed to help organizations take a holistic approach to eliminate systemic quality issues and prevent their recurrence. It builds a closed-loop CAPA workflow to determine, analyze, and eliminate the actual root cause, enabling organizations to take a proactive approach to risk management. It is a cloud-based, configurable solution that enables your quality teams to align different investigation tools, including 5 Whys, Fishbone, and many more, with CAPA processes for effective and efficient resolution. Qualityze CAPA Management comes with advanced reporting tools and an audit trail that increases traceability through CAPA trends and encourages informed decision-making. Furthermore, you can reduce the cost of product rework and meet compliance with applicable regulatory standards. It seamlessly integrates with existing business applications to give you more control and confidence in managing CAPA records. Let Qualityze CAPA Management Solution manage your CAPA-related processes efficiently than ever. Get detailed information on the CAPA module in the following presentation. If you have any more questions, please get in touch with us at 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.

1. CAPA Management
Software

2. Index:
1. Qualityze CAPA Management – Introduction
2. QCa – What’s the Need?
3. QCa – Quality Management Challenges It Helps Overcome
4. QCa – Workflow
5. QCa – Exclusive Features
6. QCa – Salesforce Platform Benefits
7. QCa – Industries It is Suitable For
8. QCa – Pros and Cons
9. FAQ’s
10. Contact Us
11. Thank-You

3. Introduction:
Qualityze CAPA Management Software enables quality teams to identify, manage, and resolve
systemic issues through a standardized CAPA process, so they don't reoccur. It uses advanced
reporting and analytics to track the problems that enable organizations to build an effective
action plan and make data-driven decisions. It simplifies root cause investigation and analysis to
detect quality problems quickly, ensuring faster CAPA cycles.
Qualityze CAPA Management Process seamlessly integrates with existing quality management
solution to provide better quality control and improve decision-making.
With Qualityze CAPA Management, you can:
• Record CAPA-Related Information to Assess Risks
• Minimize the CAPA Cycle Time
• Ensure CAPA Effectiveness
• Integrate the Nonconformance and CAPA Processes
• Leverage Seamless Integration with Existing Business Systems
• Drive Continuous Improvement
• Manage Controlled CAPA Records and Data

4. What's the Need?
A CAPA process is considered as the core of a quality system. It has a vital contribution in
achieving product quality, safety, and regulatory compliance. It eventually increases
customer satisfaction and improves the brand reputation. When CAPA is not appropriately
implemented, it may impact your workforce productivity by keeping them busy in
repetitive product failures and recalls. It implies the need for a truly effective and efficient
CAPA Management System.
And Qualityze CAPA Management Solution is the one you can rely on. It comes with
configurable forms and workflows that you can customize based on the industry's best
practices, ensuring consistency, efficiency, and compliance. It can be easily integrated with
the existing quality management systems to take a holistic approach to resolve quality
issues. The advanced reporting provides meaningful insights in real-time so your quality
manager can work more proactively towards the quality improvements.

5. Quality Management Challenges It
Helps Overcome:
Using Qualityze CAPA Management System software, you can overcome numerous quality
management challenges, including:
• Longer Process Cycles.
• Search and Retrieval of Documents.
• Traceability of Quality Issues.
• Compliance Issues.
• Collaboration and Communication.
• Increased Costs of Paper-Based CAPA Systems.
• Reliability of the Manual Root Cause Investigation.

6. Workflow:
Qualityze CAPA Management System Software is a configurable, cloud-based solution that
enables organizations to address quality issues effectively that they don't reoccur. From
reporting a CAPA issue to its root cause investigation, developing and implementing an
action plan to verify its effectiveness, you can perform all the workflow steps without
excessive training.
With Qualityze CAPA Management Software, you can standardize the process workflows
to:
• Initiate a CAPA with Critical Information
• Plan the Most Appropriate Resolution
• Investigate to Determine Actual Root Cause
• Perform Risk Assessment
• Define and Implement the Action Plan
• Perform the Verification and Effectiveness Steps
• Resolve the Quality Issues

7. Exclusive Features:
Qualityze CAPA Management comes with a set of unique features such as:
1. Centralized CAPA Database to store all your CAPA records in one place.
2. Dashboards & Reports to facilitate CAPA tracking and analysis.
3. Best-Practices Forms and Workflows for consistent and compliant data collection.
4. Electronic Signatures to maintain compliance with FDA 21 CFR Part 11.
5. Risk Matrix to simplify evaluation of risks associated with CAPA.
6. Follow-Up feature to receive alerts on activities done on a particular CAPA record.
7. Seamless Integration to make a holistic approach for eliminating quality issues.

8. Salesforce Platform Benefits:
Built on the most powerful and secure cloud platform, i.e., Salesforce.com, Qualityze
leverages enterprises:
• Flexibility, Scalability, and Security
• Improved Accessibility and Traceability
• Better Collaboration and Communication
• Low Implementation and Maintenance Costs
• Seamless Integration with Third Party Applications
• User-Friendly Interface
• Configurable Workflows and Fields

9. Industries It is Suitable For:
Qualityze CAPA Management is suitable for different industries, including:
1. Lifesciences
2. Medical Devices
3. Healthcare
4. Aerospace and Defense
5. Automotive (including Electric Vehicles)
6. Food and Beverages
7. Pharmaceuticals
8. Nutraceuticals
9. Manufacturing
10. Logistics
11. Consumer Goods
12. Cannabis
13. Biologics
14. Biotechnology
15. Construction
16. Oil and Gas
17. Hospitality
18. Chemicals and Agrochemicals

10. Pros and Cons:
Pros of Qualityze CAPA Management Software
• It comes with a free demonstration.
• It doesn't require specialized training.
• It has a user-friendly and intuitive interface.
• It helps comply with industry best-practices.
Cons of Qualityze CAPA Management Software
• No information about the free trial period or pricing online.
• Webinars not available.

11. FAQ’s:
Q. What makes Qualityze CAPA Management different?
A. Well, it is delivered on a compliant-ready platform, i.e., Salesforce.com, that ensures
more flexibility, security, and scalability to manage CAPA records in a compliant manner.
Q. Can we make changes to CAPA forms on our own?
A. Yes, with admin rights only. You can customize the workflow and forms through
Qualityze Central.
Q. What quality issues can we manage through Qualityze CAPA Management?
A. Every issue, including improper design; inadequate product specification; failure of
purchased materials; preliminary manufacturing instructions, processes, tools, or
equipment; insufficient training; scarce resources, that needs to be reported and tracked
systematically.

12. Contact Us:
If you are interested in a
free demo or want more
information about
Qualityze CAPA
Management Software,
get in touch with our
customer success team on
1-877-207-8616 or write
to us at
info@qualityze.com, and
we will be right there for
you.

13. Reach Us:
https://twitter.com/qualityze/
https://www.youtube.com/channel/UCbKQjx4H_YAE0ZkYbHTYeNg
https://www.linkedin.com/company/qualityze-inc/
https://www.facebook.com/Qualityze
https://www.qualityze.com/

14. Thank you!