Manufacturing is becoming increasingly automated and, as artificial intelligence and machine learning demonstrate, it is only going to become more so. Quality systems need to keep up, including Corrective And Preventive Actions (CAPAs). Implementing CAPA software can speed up CAPA processes, improve accuracy and promote regulatory compliance, ultimately leading to faster delivery of consistently safe, high-quality products.
If you haven’t automated your quality processes yet, this is your sign that it’s time to invest in CAPA software. This article can serve as your guide.
Contents
What are the key features of CAPA software?
What are FDA and ISO CAPA requirements?
What can CAPA software do for you?
How much does CAPA software cost?
CAPA software helps organizations identify, anticipate, track and correct defects and nonconformances to improve quality. CAPA software is often part of a comprehensive electronic quality management system (eQMS), which integrates a host of CAPA-related activities, such as document control, customer feedback, reporting and training.
By automating and connecting CAPA processes, companies can streamline and centralize data. This helps reduce the risk of human error, improving efficiency, simplifying regulatory compliance and ultimately speeding up the delivery of safer, more effective products to consumers.
Looking at the CAPA process from start to finish, there is a lot of data to be analyzed and documented, as well as tasks to be created and reported on. Those steps can be more easily managed by automating them with CAPA software. Some of the key features of CAPA software include:
CAPA software provides a framework for companies to conduct root cause analyses, such as Five Whys. These methods identify the real cause of a nonconformance or quality problem and are often the heart of CAPA resolution.
CAPA software helps in developing and implementing corrective actions to address identified issues. This includes investigation, setting the immediate or containment action and planning the permanent corrective action plan. Tasking out responsibility to interested parties is key to this phase of the corrective action.
In addition to correcting current issues, CAPA software assists in proactively identifying and implementing preventive actions to mitigate the risk of recurrence.
CAPA software should have the ability to have a structured workflow so that issues are handled in the proper order and reviewed and approved by the right parties. In addition to a structured workflow, email alerts and/or a To Do list should be present to help responsible parties be held accountable for their part of the CAPA workflow.
Good CAPA software will also have the ability to either score out risk severity or link to a risk management module allowing users to correctly assess any risk involved in a given corrective action.
CAPA software should give the ability to tag or categorize any given corrective action for trend analysis. Having robust reporting and dashboards to view analytics of your CAPA system is paramount to understanding the effectiveness of your CAPA process.
If a product or process is out of specification, modern CAPA applications electronically track the issue. You can create and prioritize nonconformances and monitor the entire process with timelines of every action. Integrations with additional eQMS applications provide a streamlined, centralized system for regulatory compliance.
CAPA software should easily integrate with quality processes, including:
FDA 21 CFR compliance standards call for regulated organizations to establish and maintain procedures for implementing corrective and preventive actions. Companies must be able to demonstrate a well-thought-out process, including methods for data analysis, root cause analysis, verification or validation of corrective or preventive actions, implementation of changes, keeping a record of changes in methods and procedures, and communicating relevant changes to management and others directly responsible for ensuring quality of the product.
ISO and GMP share CAPA standards with the FDA, however, documentation of the problem and how it was fixed is the only actual requirement.
Ultimately, companies need to be able to demonstrate to auditors that their quality system can effectively identify problems quickly and implement effective corrective and preventive actions.
There are multiple benefits to using CAPA software. Some of the major ones are:
Throughout the CAPA process, all relevant information is documented within CAPA software, including issue reports, investigation findings, corrective actions and effectiveness monitoring. This ensures a comprehensive audit trail and facilitates reporting to management, regulators or other stakeholders as needed.
Automation streamlines CAPA workflows, reducing the time and effort required for investigation, root cause analysis, and corrective action planning and implementation. CAPA software can compare current data against thresholds and alert users to abnormalities, making it easier to catch current or potential problems before they escalate. Documentation is automatically routed and reviewers alerted to necessary actions, improving efficiency and making it easy to find documents during audits
CAPA software ensures that all stakeholders are aware of issues or potential issues and necessary changes. The software facilitates the sharing of reports and documents, initiates training, and simplifies review and analysis of quality data and metrics.
By monitoring the effectiveness of corrective and preventive actions over time, organizations can get insight into recurring problems, trends and areas for improvement. You are better able to identify opportunities for further enhancements to their processes and systems, leading to continuous improvements in product quality.
Automated CAPA systems maintain comprehensive audit trails, documenting all actions taken throughout the investigation and resolution process. This audit trail is valuable for compliance purposes, providing evidence of due diligence and accountability.
By automating CAPA processes, manufacturers can more effectively identify and mitigate risks associated with product quality and safety. Timely resolution of issues minimizes the potential impact on customers, regulatory compliance and brand reputation.
CAPA software can make it easy to monitor supplier performance. Supplier data is integrated directly from the QMS application, and any issues arising from supplier inputs can be identified and addressed in a web based supplier portal.
QMS software and CAPA software generally go hand-in-hand, as any worthwhile QMS has a CAPA application. The benefits of using QMS software for your CAPA processes are plentiful.
QMS software offers data sharing across the platform, reducing the need for manual data inputs in the CAPA process, freeing up time and allowing you to address concerns and make decisions based on the most current data.
QMS software is highly focused on regulatory compliance so all regulatory aspects of CAPA management are sure to be included. In addition, QMS software can automatically schedule audits and notify you when due and link directly to other quality processes, such as documents and corrective actions.
A good QMS software also offers the opportunity to grow within the platform. Your CAPA processes will be covered, but also other functions are available to take advantage of when you are able, such as automated supplier management and customer feedback processes.
Organizations focused on life sciences, medical devices and pharmaceutical products should consider using a validated eQMS platform. Validated systems ensure that the software is in line with requirements set forth in FDA 21 CFR Part 11, 210/211and Part 820. Using a pre-validated eQMS gives life sciences companies upfront knowledge that this requirement is already taken care of.
CAPA software typically ranges from $2,000 per user, per year to hundreds of thousands of dollars per year for a highly customized solution. When choosing an QMS, pay especially close attention to the following factors:
Licensing: The most common license types are per-user and concurrent. Per-user licensing is just as it sounds -- one license per an individual user. Some QMS software providers charge per user but offer pricing options based on functionality. For instance, if a user needs “read only” access, associated fees for that type of license will be lower.
Concurrent licensing allows companies to have multiple users on one licensing code. If a company purchases five concurrent licenses, then five of their employees can use the software at any given time.
Applications included: Many QMS software providers offer pricing plans that start with a base of capabilities and increase in cost as extra capabilities are added. Make sure your non-negotiable functions are part of the core applications provided in the plan you’re considering, and be aware of which applications are add-ons and at what cost.
Data limitations: You’ll also want to consider how much data the platform is able to store for you or if there are costs associated with different levels of data storage. A platform with unlimited data storage is ideal, but many companies have maximum data or document limitations.
Implementation and training: Be sure to find out if software implementation and training are included in presented costs or if they will be additional charges. Find out what kind of services are included in these services and at what cost. Sometimes training is free but limited, for instance, to on-line information libraries.
Additional fees: Be sure to ask about any additional fees, such as annual subscription fees or charges for software updates. Some QMS software providers charge for customer support, for example. You’ll want to make sure you factor additional fees into your cost examination.
Scalability: Consider whether the QMS software you’re considering offers applications that you can grow into as you either master other applications or as your business evolves and grows. Will there be an extra cost down the road when you need those capabilities?
QT9 eQMS is consistently one of the top-rated quality management systems available. It is versatile for companies big and small with truly unlimited scalability. This easy-to-use platform centralizes and automates quality processes for the most highly regulated industries, including medical device manufacturers, life science companies and aerospace companies. It is a great all-around option for companies with over 25 modules included for better data centralization and analytics.
It’s not just us. QT9 QMS is loved by customers and auditors alike.
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