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CAPA Management
Qualityze Cloud-Based CAPA Management Software
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CAPA Management overview
What is CAPA Management?
One of the main reasons the FDA issues 483 observations to medical device manufacturers is that its CAPA process is poorly defined or implemented. Establish a CAPA process, follow your process, and ensure compliance. Qualityze CAPA Management has well-defined CAPA processes and workflows built right into the platform for your convenience.
All your things, even your design controls, feed into that system or process, making it easy to find the data you need without having to go searching elsewhere. There is no data loss. There are no gaps.
Using the Qualityze CAPA Management Solution, you can eliminate quality event process inefficiencies by eliminating excess documentation and automating the quality event process. You can automate step-by-step processes by creating custom workflow templates that adhere to your company's protocols. Maintain a single, up-to-date workflow for your CAPA process, with management controls that automate action items and assign them to the right person or team - increasing your team's efficiency.
You also gain visibility into the impact of all quality systems, such as audits, nonconformances, and customer complaints, on the CAPA system when you manage all data and CAPA processes in a single system. Through a single system, you are now able to see across functions so you can make the best decisions.
Qualityze CAPA Management helps track quality issues in real-time; you can solve them before they become a regulatory issue. Make proactive quality decisions rather than reactive ones.
Here’s the workflow for Qualityze CAPA Management Software:
By using Qualityze CAPA Management, organizations can create a risk-based, compliance-based process for dealing with systemic issues. It provides a comprehensive approach for mitigating quality issues while maintaining compliance and fostering a culture of continuous improvement.
CAPA process begins by documenting critical information such as Problem Statement, Defect, CAPA Source, Product, Process, Criticality, Severity, Initiating Site, Risk Assessment & Immediate Action.
To identify potential root causes, you can conduct the investigation using one or more investigation tools. Additionally, the risk matrix is used to assess risk visibility and support the development of action plans.
You can choose risk-based, correction, corrective, and preventive action plans based on the identified root causes.
The CAPA can be validated and verified by verifying the effectiveness of the action plan implemented in advance of the closure.
Integrating risk assessment and root cause analysis into your quality system is crucial for eliminating inconsistencies. By standardizing the CAPA process with Qualityze, you can:
• Initiate a CAPA with all important details
• Identifying the most appropriate resolution
• Determine the actual cause of the problem
• Conduct risk assessments
• Establish an action plan and carry it out
• Check the effectiveness of the plan
• Resolve quality issues
Key benefits of using CAPA Management
CAPA enables your organization to remain alert for any nonconformances, ultimately enhancing quality control within your organization. In addition, business owners can gain certifications for conforming to industry standards and pass FDA and other regulatory audits with this technology.
Following are a few of the benefits of using CAPA Management software:
Data retrieval is easy and hassle-free
Integrating CAPA management software into existing systems helps you record and maintain data more efficiently and makes data retrieval easier.
CAPA software can log details about hundreds of processes within a single day. The review includes processes such as identifying problems and issues, taking actions to rectify them, and following SOPs to resolve them.
Consequently, every CAPA iteration should be accompanied by detailed reports. Qualityze CAPA management software provides you with access to the data on-demand without the need to meet with other workers, call them, or email them.
Keeping track of action plans and resolutions
Keeping CAPA management in operation is a common challenge that organizations face. Despite recognizing non-conformances in business procedures and processes, their non-conformances are not mitigated. As a result, the organization fails regulatory audits by authorities.
However, using CAPA management software, you can make the process less complex. When a nonconformity is recorded, the Qualityze CAPA management software will keep the record in progress until its resolution. While that is happening, a record will be saved, and a reminder sent to the assigned team. In addition, updates regarding the ongoing corrective action will be added to the software. The status will be updated once it has been completed.
The CAPA software will notify every one of the updated SOP's to be followed across the board. As part of this analysis, the output results of the process should also be evaluated to ensure they conform to the quality standards.
Assigns tasks effectively
By assigning mitigation and resolution tasks to specific workers, Qualityze CAPA management software allows better control and efficiency. In addition, all critical stakeholders on board improve CAPA and enable collaboration.
Automated reminders are supported
The SOPs must be regularly updated to avoid overlooking CAPA processes. Every employee and member can be reminded about operational procedures changes when Qualityze CAPA management software is used, ensuring coordination between all divisions of your business.
Audits your CAPA process more efficiently
When you use software like Qualityze CAPA management software, you can significantly simplify this process since the auditor knows that the software cannot be altered. The data projections and findings are 100% accurate. The auditor can review the software to get a detailed view of your quality control process, including how quickly you can act to stop non-conformances.
It is advantageous to your organization and auditors because it speeds up the certification process. And meeting compliance with regulatory requirements gets more manageable too.
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CAPA Management FAQs
CAPA Management has the following pricing plans:
Starting from: $30.00/year
Pricing model: Subscription
Free Trial: Available | (No Credit Card required)
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Q. Who are the typical users of CAPA Management?
CAPA Management has the following typical customers:
Large Enterprises, Mid Size Business, Small Business
Q. What languages does CAPA Management support?
CAPA Management supports the following languages:
English, Bulgarian, Chinese (Simplified), Chinese (Traditional), Croatian, Czech, Danish, Dutch, Finnish, French, German, Greek, Hebrew, Hungarian, Indonesian, Italian, Japanese, Korean, Latvian, Polish, Portuguese, Romanian, Russian, Slovak, Spanish, Swedish, Thai
Q. Does CAPA Management offer an API?
Yes, CAPA Management has an API available for use.
Q. What level of support does CAPA Management offer?
CAPA Management offers the following support options:
Email/Help Desk, Knowledge Base, Phone Support, 24/7 (Live rep), Chat, FAQs/Forum




