Top 5 CAPA Management Software Systems in 2024

Companies in regulated industries must have a formal process for managing corrective and preventative actions (CAPAs). Identifying problems, analyzing root causes, implementing solutions, and verifying that problems have been resolved are all part of this process. CAPA management software helps companies manage this process and stay compliant. Therefore, you must choose CAPA software carefully to avoid significant regulatory risks for your business. Find out what to look for in CAPA software and what functions your CAPA management system needs. 

CAPA Software: What is it? 

CAPA software facilitates the management of corrective and preventive actions. In addition, a CAPA management system simplifies the process of complying with FDA standards. Root cause analysis and risk assessment are typical CAPA management features.  

CAPA Software – Why? 

CAPA causes more compliance issues for life sciences companies than any other. Each year, it triggers FDA non-compliance warnings under 21 CFR 820. In addition, CAPA management requires specialized software, so organizations need an eQMS with CAPA capabilities. Many organizations that receive warning letters did have corrective action software, but it failed. This indicates that organizations must rigorously research their software options regarding CAPA management. 

Related Blog: Ignoring these 7 Signs Can Get You FDA Warning Letter

Selecting CAPA software

To correctly manage CAPAs, a long-term solution from a reputable vendor is usually a sound investment, as documenting events and corrective actions remain a requirement throughout the product lifecycle. You should know that not all CAPA software is the same. In addition to price, you should consider ease of use, regulatory compliance, scalability, and customer support. Here is a blog having information about the top 5 CAPA Management Software available in the market with their pros and cons.

Generally, CAPA integrates with audit, nonconformance management software, document management, and Change Control Management to provide adequate safeguards against regulatory risk. 

To simplify CAPA software selection, we have curated a list of top 5 CAPA Management Software Systems with their pros and cons. You can analyze the options to choose the most appropriate one for your business. 

An Overview of the Top 5 CAPA Management Software Systems

• Intellect 

With Intellect, you can achieve FDA and ISO compliance and digital transformation goals. It leverages Intellect Compliance Platform, Intellect’s no-code platform, to offer the most configurable eQMS solution in the market. The Intellect EQMS  Software integrates today’s and tomorrow’s quality management needs.  

Pros  

• • 1. • This is user-friendly and flexible QMS software. 
       • The ability to configure without professional assistance. 
       • Each field and page can be customized to meet the needs of companies as well as regulatory requirements.

Cons (According to the Reviews) 

• • 1. • Programming skills and training are required for software customization. The troubleshooting option could be more effective and time-consuming. 
       • In the pharma/med device industry, most OOB workflows and configurations are not representative of typical QMS workflows.  
       • Initial understanding of the system macros was challenging. 
       • A Management Review app would be an excellent addition to the software.

• Qualityze

The Qualityze EQMS Suite is a Salesforce-based compliance and process management system for developing and sustaining high-quality procedures and policies. Organizations of all sizes can standardize processes and integrate them into one EQMS system with the Qualityze EQMS Suite. A simple, scalable Qualityze EQMS Suite has been developed to manage quality issues. 

Organizations use the Qualityze CAPA Management System to address systemic issues that prevent recurrence by developing a risk-based, compliance-driven process. It guides the user to mitigate quality issues, meet compliance, and foster a continuous improvement culture. With our integrated solution, you can make better decisions faster and more efficiently. The dashboard gives you insights into CAPA trends, performance, and effectiveness. There are many investigation tools available in the system including 5 Whys, Six Sigma, and more. 

Pros 

• • 1. • Qualityze is an out-of-the-box, ready-to-use EQMS Suite.
       • It seamlessly integrates with enterprise-wide quality management systems to provide the required traceability of CAPA events.
       • Knowledgeable customer success team to provide assistance 24*7.

Cons (According to the Reviews) 

• • 1. • The learning curve for Qualityze Suite can be steep for small businesses.
       • More room to develop features

• Greenlight Guru 

With Greenlight Guru, you can manage quality in medical devices using a cloud-based system. Its pre-market and post-market solutions, Greenlight Go and Greenlight Grow cater to a wide range of markets and customer needs. The design control feature of Greenlight Go allows users to maintain traceability. The user can create design control objects and attach documents to them. In addition, the solution enables the automatic routing of documents and revision control. Greenlight Go software also provides users with an overview of the relationship between requirements, risks, and verification tests. 

Pros 

• • 1. • The system is easy to navigate and use, even for a layperson.
       • This provides a very effective way to link design and risk with documents and approvals. 
       • Response time to customer service is quick. 

Cons (According to the Reviews) 

• • 1. • The extensive repository of documents will be better organized in the future.
       • Best practices can be challenging and time-consuming since all customers receive a single standard offering without customization options. 
       • Functionality is severely limited.

• Quinton

With Quinton, businesses of all sizes can manage their environmental, health, and safety (EHS) compliance and training needs across many industries, such as healthcare, consumer goods, manufacturing, automotive, chemical (HazMat) management, compliance management, training management, on-demand training, risk assessments, audits, sustainability management, environmental management, and corrective actions on a cloud-based platform. Native Android and iOS apps are available for the solution. Several features are included in the system, including collaboration, document management, escalations, planning, deadlines, and task assignment. By mapping actions and documents to the company structure, Quentic allows users to see the company’s structure. Admins can group users according to their tasks, including employees and third parties. Business processes can be audited against industry standards with the solution. 

Pros  

• • 1. • A lot of functionalities are available in a single system.
       • Whether it’s a management report, a legal compliance overview, or the option to store documents in real-time. 
       • It increases the effectiveness and efficiency of day-to-day operations. 

Cons (According to the Reviews) 

• • 1. • It may be difficult for inexperienced users to navigate the tool since it offers many features.  
       • The interface can be a bit confusing. 
       • Keeping data and policies updated in the software can be overwhelming.

• QT9

It is a web-based quality management system companies use to comply with ISO and FDA quality standards. You can deploy the software either on-premises or in the cloud. Using this tool, paper records are replaced with electronic ones. It helps companies manage their day-to-day work and ensures full transparency. Employees can set up email reminders to stay on top of their project modules within time limits through QT9. A QMS system also electronically tracks nonconforming products, employee corrections, document control, training, and other quality modules. Employees can approve, verify, and reject project work through the application’s module approval system.  

Pros 

• • 1. • QT9’s technical assistance makes document upload faster.
       • Friendly, intuitive interface

Cons (According to the Reviews) 

• 1. • It would be beneficial to create corrective action and non-conformance records from a customer complaint. In the current software, both can only be done one at a time.
     • Quite a few filters require a bit of practice. There are times when they default, and employees need a little extra coaching. 

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