CAPA Online

CAPA Online Management Software Systems from MasterControl Automate Corrective Actions and Processes

In regulatory environments, the focal point of any quality system is corrective and preventive actions, or CAPA. An organization's combined efforts to investigate and correct quality issues - and to prevent their recurrence - are crucial to maintaining compliance with regulatory standards. A solid CAPA program is critical to sustaining long-term product quality as well. Maintaining compliance with globally recognized regulatory requirements (FDA guidelines, ISO standards, etc.) is particularly crucial. Managing CAPA online with a proven automated solution that has been properly implemented can improve product quality and safety, enhance the customer experience, and - most importantly - ensure compliance with established regulatory guidelines.

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CAPA Part 1 Improving CAPA Systems with a Closed-loop Methodology
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How can MasterControl's CAPA Online Management System Benefit Your Business?

The CAPA online management software system available from MasterControl is a robust, user-friendly tool engineered to effectively manage corrective/preventive action processes and integrate corrective online actions with other processes essential to regulatory compliance, such as change control, audit, nonconformance, and customer complaints. The automated MasterControl system is web-based, which gives authorized users the opportunity to participate in CAPA processes from virtually anywhere in the world.

CAPA Online Management Challenges

The MasterControl CAPA online software solution addresses some of the most problematic issues that organizations face while trying to establish an effective CAPA program. Such CAPA management challenges may include:

  • Paper-based or hybrid CAPA management systems may be the cheapest way to get up and running quickly, but they are short-term solutions that can't keep pace with burgeoning companies in competitive industries. Compare paper-based systems with the long term effectiveness of proven CAPA online management software tools. Paper-based systems are inefficient and prone to manual errors. They require the dedication of countless man-hours for routing, approving, or escalating CAPA tasks and other related documentation, obtaining approval and signatures, and manually searching for and retrieving documents during audits or inspections.
  • Disparate and/or disconnected systems make CAPA online tracking and resolution a convoluted nightmare. For instance, a CAPA may be triggered by Form 483 findings, ISO quality audits, customer complaints, or another similar source. With manual and hybrid CAPA management software systems, these sources are disconnected, making data collection tedious and often incomplete. Without tightly integrated CAPA online connectivity, critical information will inevitably slip through the cracks, and the root causes of investigations can't be relied upon.
  • Poor implementation of a (usually inadequate) CAPA program leads to the issuance of a Form 483. This is an all too frequent occurrence with insufficient CAPA online management systems. This problem often stems from the system's inability to track and monitor open CAPAs and proactively improve internal CAPA processes.

Overcoming CAPA Challenges with CAPA Online Management

Here's how leading CAPA online management software systems like MasterControl can help companies overcome CAPA challenges:

  • MasterControl automates the management of the entire CAPA process, from initiation through investigation, all the way to closure. A comprehensive CAPA online management solution like MasterControl provides a secure, centralized, and web-based repository where all CAPA-related documents are easily accessible. When a venerable CAPA online management system like MasterControl can automate all the routing, notification, delivery, escalation, and approval of CAPAs (and all associated documentation), resources and time are saved and headaches are avoided.
  • The MasterControl CAPA online management software system integrates the CAPA process with the rest of the quality system, forming a holistic, connected solution that saves the organization time and money and reduces wasted resources and effort. Take, for example, the time and manpower saved by automating triggering: the resolution of a corrective action can be set up to automatically launch an engineering change, an SOP change, and a retraining task to educate employees on the new SOP. This saves managers countless hours of tracking down signatures, scheduling training sessions, informing multiple teams of changes, etc.
  • MasterControl CAPA online management software systems track all quality incidents that can escalate into a CAPA, such as customer complaints, audit findings, nonconformances, etc. The CAPA management system comes complete with advanced analytics and reporting capabilities, including detailed customizable reports and online charting. Through the reports that can be generated generated, managers get a real-time view of the CAPA process and can be more proactive about improving not just the CAPA actions, but the overall quality system itself. The CAPA system available from MasterControl also maintains links so users can review a completed process and easily see what triggered a CAPA and plan corrective actions accordingly.

Features to Look for in CAPA Online Management Software Systems

  • Connected Quality Processes: Comprehensive and effectual CAPA online management systems are be designed as "closed loop" solutions. This means that they should have a proven track record of being able to streamline processes and connect all quality subsystems and that they should provide adequate monitoring of quality incidents that could potentially escalate into a CAPA. Customers, vendors, and other authorized external users should be able to submit a form from any location through the CAPA management system. For instance, a customer complaint forms or a product issue report that could potentially escalate to a CAPA should be remotely accessible to authorized users from any location with an internet connection. Off-site or traveling users should also have the ability to fill out forms pertaining to the CAPA process without being directly connected to the CAPA software. A comprehensive CAPA system like MasterControl gives these users the ability to complete forms offline and then upload them when as needed.
  • Forms Based on Industry Best Practices: Companies doing business in regulatory environments need the flexibility of having best-practice electronic forms and workflow routes pre-built into the system that can be implemented right out of the box as well as forms that can be customized based on organizational requirements. MasterControl CAPA online management offer both. MasterControl utilizes an "8D" process that can guide quality teams through each step of CAPA implementation, from identification of the problem to investigation of root causes, all the way through to the correction of the problem and reoccurrence prevention.
  • Integration Capabilities: A powerful CAPA online management system like MasterControl offers users the potential to integrate CAPA with other elements of the quality system (the training or audit applications, for instance) to form a more efficient, streamlined master system. With MasterControl's CAPA software system, a CAPA that causes a change in product design or function automatically launches training tasks whenever an approval of any change takes place. In addition, the CAPA system automates the distribution and grading of online training exams, which can be used as proof of employee competency during FDA inspections, ISO audits, and other similar assessments.
  • Advanced Analytics and Reporting Features: CAPA coordinators must be able to monitor the entire quality management lifecycle, from input to closure. An effective CAPA online system must provide an all-inclusive picture of the quality system. When shopping for CAPA management systems, the following questions must be taken into account regarding the available reporting features:
    1. Does the system have the ability to dynamically capture, trend, and link data needed to solve problems?
    2. Do the reporting features provide the information required to improve overall quality processes?
    3. Does the CAPA system give our company viable implementation of effective preventive measures?

Also keep in mind that certain reports (issue summary, aging/overdue, cycle time, etc.) should come standard with the CAPA online management software system. Evaluate your own organizational requirements to determine if the CAPA software should also include customizable reports for issue review, problem prevention, etc., such as those offered by MasterControl.

At very least, any CAPA online management system worth the cost of investment should provide increased efficiency through automation and should be based on industry best practices. MasterControl streamlines and simplifies all tasks pertaining to each CAPA action, including notification, follow-up, and escalation of overdue assignments. Automation simplifies the compliance environment, making it easier to achieve and maintain long-term compliance.

Learn More about CAPA Online Management Software Systems

To learn more about our CAPA online management software systems contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.