How to choose CAPA software: 8 essential functions
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In the life sciences industry, regulators require that companies have a formal process for managing corrective and preventative actions (CAPAs). This includes identifying problems, conducting root cause analysis, implementing solutions, and verifying that the problem has been resolved. To manage this process and stay compliant, companies turn to CAPA software. Choosing the right CAPA software is important to ensure that your company isn't at significant regulatory risk—here's what you need to know about CAPA software and the functions that are essential for the best CAPA management system.
What is CAPA software?
CAPA software is a specialized application that helps organizations manage corrective and preventive actions. CAPA management technology is designed to simplify the process of complying with FDA requirements for CAPA processes. CAPA management software typically includes features such as document control, issue tracking, risk assessment and root cause analysis.
Why do you need CAPA software?
CAPA causes more compliance trouble for life sciences companies than any other area of quality management. Year after year, it's the number one trigger for FDA 21 CFR 820 noncompliance warnings. It’s clear that organizations need a specialized software application for CAPA management, or an electronic quality management system (eQMS) with robust CAPA capabilities. In many cases where an organization received a warning letter, it’s likely that their corrective action software was in place, but it failed for one reason or another.
Free CAPA software options
There are a number of free CAPA software options available, but it's important to consider the trade-offs. In most cases, you get what you pay for—free CAPA software may be sufficient for small companies with simple needs, but it's likely not going to be enough for larger organizations with more complex requirements. Many free CAPA software offerings are trial periods, which expire after a certain amount of time like ISOTracker's 60 day free trial promotion.
Choosing the best CAPA software
Investing in a long-term solution from a reputable vendor is usually worth the money when it comes to CAPA management, since the need for documenting quality events and corrective and preventative actions remains a requirement throughout the product lifecycle. It's important to remember that not all CAPA software is created equal. You'll want to consider a number of factors before making a decision, including ease of use, regulatory compliance, scalability, and customer support—in addition to price.
To provide effective safeguards against regulatory risk, CAPA is generally a module within a comprehensive electronic quality management system (eQMS) or capable of integrating with management systems for audits, nonconformances, document management and change control.
How do you choose CAPA software that ensures compliance, quality and customer satisfaction? We'll review the eight key functions.
CAPA software: 8 must-have functions
The FDA offers minimal guidance for selecting a CAPA system aside from referring organizations to consider cGMP and software which facilitates a quick response to complaints.
FDA Postmarket and Consumer Branch Chief Joseph Tartar shared: “Manufacturers should consider [if] their corrective action and preventive action documentation can demonstrate to FDA that the manufacturer’s quality system is effective and enables the manufacturer to identify problems quickly and implement effective corrective and preventive actions.”
At a high level, your CAPA system must:
- Include CAPA procedures which address quality system requirements
- Facilitate data analysis to identify the sources of product quality concerns
- Enable organizations to monitor trends for preventive action
- Integrate with surrounding systems and QA processes to assure data quality
- Facilitate statistical analysis and formal failure investigations
- Allow organizations to validate the success of preventive or corrective actions
While these requirements are useful, they don’t translate directly into software features or help you identify which CAPA software options are likely to fail in a real-world implementation. Fortunately, by understanding the cGMP and CAPA process, you can identify the following eight key capabilities:
Related reading: 6 most common warnings for FDA 21 CFR 820 noncompliance
1. CAPA reporting
Any CAPA software needs to offer basic functionality for quality event and CAPA reporting. This is defined as a standardized report template for recording defects or complaints and the steps taken to correct an issue. At a minimum, your organization's CAPA report should include details such as:
- Issue description
- Action taken
- Resources and team members
- Planned resolution date
- Actual resolution date
Documenting these basic characteristics of your CAPA program is a bare minimum component of complying with FDA cGMP requirements. However, basic CAPA capabilities which provide evidence in case of an audit isn’t usually enough.
Ineffective reporting is among the top reasons CAPA software fails to protect organizations from true risks such as poor product quality or waste. If your CAPA solution offers reports which are little more than spreadsheets or documents, it can quickly become a catch-all for user-generated data. These reports can build up in the system. Unless you have someone specifically dedicated to managing CAPA, these reports can be overlooked or forgotten. Issues may never be effectively resolved, which can spiral into costly quality concerns.
Perhaps most importantly, basic reporting capabilities don’t allow your organization to filter or understand trends. In addition to documentation, your reporting should offer insight into emerging issues so you can take preventive action, and understand when small data points are telling a larger story. While small issues should be handled as nonconformances, CAPA reports are an important management tool for creating process improvements.
A CAPA management system must integrate with your other systems and technologies for quality management or be part of an QMS software. If your CAPA management doesn’t integrate with surrounding systems, you’re losing opportunities for automation and opening yourself up to errors by entering CAPA data manually.
Most importantly, CAPA management that doesn’t integrate with surrounding QMS systems can easily cause your organization to lose track of CAPA timelines. The single biggest advantage of a CAPA software that's fully integrated with your eQMS is organization-wide visibility.
Integrations can also lead to process improvements, including:
- Elimination of data entry or data quality concerns
- Assignment of due dates and notifications to global users
- Better communication with supply chain vendors
- Tracking trends in quality with closed-loop reporting
- Launching deviation reports or customer complaint forms linked to CAPA forms
- Ability to trigger updates to SOPs based on preventive or corrective action
3. CAPA forms
Your CAPA software should facilitate streamlined quality operations by offering intuitive forms that are easy for users to complete correctly every time. Consider whether a software offers robust document management features to support your need for intuitive CAPA forms. Capabilities to look for include:
- Cloud-based files, folders, and documents
- Web-based template editors
- Guided form workflows
- Intuitive drafting, review, and approval processes
- FDA CFR Part 11 compliant digital signatures
4. Linked quality processes
Too often, organizations cite “training failures” as the root cause of an issue during CAPA investigations. Nonconformances and complaints may be linked to human error, but training is almost never the actual root cause of an issue. Generally, there was a failure somewhere in an organization’s quality system if an individual failed to follow procedures. Perhaps they didn’t have an SOP available at the point-of-work. While a resulting error could be chalked up to failure, it’s more correctly a management failure to provide SOP access.
Your organization can perform more effective root cause investigations and drive better improvements if your CAPA is linked to company-wide quality processes, which generally occurs when CAPA is a module in a QMS software. If CAPA is a standalone system, it’s easy to treat issues as isolated incidents which can be resolved and then forgotten. When CAPA is linked to data, reporting, and documents, it’s easier to drive quality improvements and understand what’s really going on behind the scenes with trend analysis and triggered updates to your SOPs.
5. Automated reminders
Your system should make it difficult to forget or neglect issues or let problems build up in the system. CAPA software should improve collaboration and help your organization avoid unnecessary meetings, emails, and communication while mitigating regulatory risk. The best quality management software should allow issues to be assigned and automate the process of resolution, even if you’re managing a busy, globally distributed team. Software capabilities should include:
- Assign issues to team members
- Automated notifications
- Support for comments and collaboration
- Cloud-based access for global teams
- Mobile application support
Quality teams don’t intend to neglect or forget issues, they simply lack tools which make it easy to effectively complete CAPA processes. Guided workflows are crucial to a streamlined CAPA program and helping your organization close issues on time. Consider whether your CAPA software offers step-by-step guided workflows for consistent quality, automated reminders, and links between quality processes to exceed regulatory requirements and achieve quality improvements.
7. Automated data entry
Noncompliance can occur easily if your CAPA system relies on manual data input. If CAPA-related work is tedious or time-consuming, staff members may push it aside in favor of tasks which feel more productive. In other cases, manual data input requirements can lead to data quality issues, such as inconsistency in reporting or data input errors.
Quality issues are a regulatory risk and inconsistency makes it difficult to perform effective analysis of trends. Your CAPA system should facilitate process automation by providing inputs from linked quality systems:
- Supplier management
- Risk management
- Design controls
8. Full audit trail
When evaluating CAPA software options, consider the quality of the audit trail capabilities. A CAPA management system must offer sufficient audit trail requirements to avoid FDA noncompliance. In addition to meeting these minimum guidelines, it should provide a full audit trail to support data-driven management.
The CAPA management system should, ideally, operate as a single place to understand how issues are linked to the entire organization and take preventive action in real-time. It’s impossible to adopt a proactive approach to preventive action with CAPA software that relies on manual data input. By using a system for closed-loop intelligence, you can exceed regulatory requirements for audit trails and make data-informed decisions for quality operations.
Invest in CAPA software early
When companies are first establishing their quality management system, CAPA software can feel like an afterthought. Because early-stage companies don't feel urgency to setup a CAPA process, you may simply choose to verify that a QMS offers that capability and instead focus on modules which meet your current needs. However, FDA warning letters tells another story.
Make finding the right CAPA software a priority. Take a look at Qualio's CAPA management software.