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.
In one recent year, nearly 83 percent of warning letters cited CAPA as an area of non-compliance at FDA-regulated organizations, although some organizations were noncompliant in one or more areas (such as CAPA and purchasing controls, or CAPA and process validation requirements).
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 the technology was in place, but it failed for one reason or another.
How do you avoid getting stuck with a CAPA management software which leaves your organization open to costly regulatory risk or quality issues that can threaten patient safety?
There are eight key capabilities that separate great options from average or risky solutions when it comes to avoiding the risk of noncompliance with CFR 820. It’s crucial to keep these functions in mind if you’re looking for a new CAPA software or evaluating your current system.
CAPA Management Software: 8 Must-Have Functions
CAPA management software is a technology designed to simplify the process of complying with FDA requirements for corrective action/preventive action processes. 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, change control, and other capabilities.
The FDA offers minimal guidance for selecting a CAPA system which reduces regulatory risk, aside from referring organizations to consider cGMP and software which facilitates a quick response to complaints. “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,” says FDA Postmarket and Consumer Branch Chief Joseph Tartar.
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 eight key capabilities, from powerful reporting to comprehensive audit trails.
Related Reading: The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance
1. Powerful Reports
Any CAPA management software needs to offer basic functionality for 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 non-conformances, CAPA reports are an important management tool for creating process improvements.
2. Seamless Integrations
A CAPA system must integrate with your other systems and technologies for quality management or be part of a comprehensive QMS software system. If your CAPA doesn’t integrate with surrounding systems, you’re losing opportunities for automation and running data quality risks by entering CAPA data manually.
Most importantly, a CAPA which doesn’t integrate with surrounding QMS systems can easily cause your organization to lose visibility of CAPA from a timeline perspective. This can occur quite easily, especially if you have a large volume of issues or your staff members are busy. The single biggest advantage of a CAPA management software which is fully integrated with your eQMS is organization-wide visibility.
Integration can also lead to process improvements, including:
- Elimination of data entry or data quality concerns
- Creation action items to global staff members with due dates and notifications
- Launching deviation reports or customer complaint forms linked to CAPA forms
- Ability to trigger updates to SOPs based on preventive or corrective action
- Tracking trends in quality with closed-loop reporting
3. Intuitive Forms
The most effective software is software which people use consistently. Ideally, it should introduce automation and make people’s jobs easier to do. Your CAPA management software should facilitate streamlined quality operations by offering intuitive forms that are fast and simple for staff members 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
Related Reading: What is the Best ISO 13485 Quality Management System Software?
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 CAPA system should make it difficult to forget or neglect issues or let problems build up in the system. A CAPA should improve collaboration and help your organization avoid unnecessary meetings, emails, and communication across systems 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.
Capabilities should include:
- Assign issues to team members
- Automated notifications
- Support for comments and collaboration
- Cloud-based access for global teams
- Mobile application support
6. Step-by-Step Guided Workflows
CAPA is a key cause of noncompliance warning letters due to a lack of process consistency. Organizations 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 streamlined CAPA and helping your organization close issues on time. Consider whether a 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 rapidly lead to risky data quality issues, such as inconsistency in reporting or data input errors.
Quality issues are a regulatory risk, and inconsistency makes it very difficult to perform effective analysis of trends at a high level. Your CAPA system should facilitate process automation by providing automated 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 solution 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 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 a CAPA management software which 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.
Prioritizing CAPA Management Software
CAPA management software doesn’t always seem like the most important solution for FDA-regulated organizations in pharma, life sciences, or the medical device industry. When startups and small organizations who are working toward market approval are evaluating QMS systems, CAPA can be an afterthought. Since your organization doesn’t have an active need for CAPA, you may simply choose to verify that a QMS offers that capability and focus on modules which meet your current use cases. However, data on the most frequent causes of FDA warning letters tells another story.
Your organization can avoid regulatory risk and derive business value from your CAPA system by selecting a robust solution that’s fully integrated with your QMS suite. When CAPA processes are automated and linked to surrounding quality systems, you can avoid regulatory risk and take a proactive approach to root cause analysis and preventive/corrective actions.
Finding an eQMS which is right-sized for your organization’s needs is also important, especially if your company has aggressive growth goals. Select a QMS software which is specifically designed for small to mid-sized life sciences companies to scale without assuming regulatory risk.
If you'd like to take a look at our CAPA management software designed for the life sciences industry, schedule a demo now.