Corrective Action Software Preventive Action (CAPA) Software System Features & Benefits

Automating Corrective Action CAPA Processes in FDA and ISO Compliance Environments

Corrective and Preventive Action (CAPA) the overall effort to investigate and correct quality issues to prevent recurrence is the crux of any quality system. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. When implemented properly, a CAPA system improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance.

MasterControl offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They are designed to allow "continuous validation" for FDA-regulated companies by making validation of software upgrades easier, faster, and more cost-effective.

How can MasterControl CAPA™ Benefit You?

MasterControl CAPA™ is a robust, easy-to-use system designed to effectively manage the corrective action / preventive action process and integrate it with other processes critical to regulatory compliance, such as change control, audit, and customer complaints. Here's how MasterControl CAPA addresses some of the major challenges that companies face in establishing and maintaining effective corrective and preventive action processes:

Corrective Action Preventive Action CAPA Management Challenges		MasterControl CAPA™ Software System
Inefficient Corrective Action System Paper-based and hybrid CAPA systems are inexpensive initially. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing CAPA tasks and other documentation, obtaining approval and signatures, and manual search and retrieval of documents during inspections and audits.		Efficient CAPA Process Management Software MasterControl CAPA automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. It automates management of entire CAPA process, from initiation to investigation and all the way through closure. Provides a secure, centralized, and Web-based repository for all CAPA documents.
Disconnected CAPA Processes A CAPA may be triggered by Form 483 findings, ISO quality audits, customer complaints, or some other source. With manual and hybrid systems, these sources are not connected, making data collection slow and incomplete. Without connectivity, critical information may fall through the cracks, and the root cause investigation is likely to be unreliable.		Connected CAPA Management Software System MasterControl integrates the CAPA process with the rest of the quality system for a holistic approach. For example, the resolution of a corrective action will trigger an engineering change, an SOP change, and retraining of employees on the new SOP.
Poor CAPA Reporting System When customer complaints, deviations, adverse events, and other incidents that can trigger CAPA are collected manually, there's no guarantee that all critical information will be captured because it is easy to misplace (and time-consuming to update) paper reports. A hybrid system requires re-entering data from hard copy into an electronic system, a process prone to delay and mistakes.		Efficient CAPA Reporting System A CAPA form can be launched directly from another form (i.e., customer complaint, etc.) to streamline the CAPA process and avoid mistakes during re-entry of data. Links are maintained so users can review a completed process and easily see what triggered the CAPA.
CAPA System: Lack of Oversight Poor implementation of CAPA (a top reason for issuance of a Form 483) may stem from the lack of ability to track and monitor open CAPAs and proactively improve the CAPA process.		Increased Oversight The MasterControl system tracks quality incidents that can escalate into a CAPA, such as customer complaints, audit findings, etc. The system provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the CAPA process and can be more proactive about improving their quality system.

Features

Best-Practice Forms: MasterControl provides best-practice electronic forms and workflow routes that can be used as is or customized based on a company's needs. The solution includes:

• An "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem to investigation of root cause through correction of the problem and prevention of recurrence.

• A CAPA form that can be configured to show the initiator only the relevant information to this step and to require completion only of fields related to data entry.

Connected Quality Processes: MasterControl is designed as a "closed loop" solution, streamlining processes, interconnecting different quality subsystems, and tracking quality incidents that can escalate into a CAPA. For example:

• A CAPA form can be launched directly from another form (i.e., customer complaint, audit findings, etc.) to streamline the CAPA process. Links are maintained so users can review a completed process and easily see what triggered the CAPA.

• Relevant data from a form that could potentially require a corrective action is automatically entered into a CAPA form, reducing data entry and eliminating errors from manually transferring information.

• Through the Internet, customers, vendors, and others outside the company can submit a form, such as customer complaint or product issue report, that could lead to CAPA. Off-site and traveling users can also complete forms pertaining to the CAPA process without being connected to the MasterControl system. They can complete forms offline and then upload.

• CAPA can be integrated with the training application for a more efficient system. A CAPA that causes a change in product design or function will invoke training tasks upon approval of the change. MasterControl can automate distribution and grading of online exams, which can be used as proof of personnel competency during FDA inspections or ISO audits

Advanced Analytics and Reporting: With MasterControl, CAPA coordinators can monitor the entire quality management lifecycle, from input to closure. They will get a complete picture of the quality system with the help of the following reporting capabilities:

• Ability to dynamically capture, trend, and link data needed to solve problems, improve processes, and implement preventive measures. A variety of reports (issue summary, aging/overdue, cycle time, etc.) come standard. You can customize reports for issue review, problem prevention, etc.

• Data can be grouped together by a date interval and then charted over a date range. For example, the number of customer complaints can be totaled for each week and charted for the last year. Data can be summarized in multiple levels, so CAPAs can be reported by product, department, and root cause.

Additional Features

• Increased Efficiency Through Automation: MasterControl automates all tasks pertaining to each corrective action, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.
• Best-practice electronic forms and workflow routes: Includes an "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem to investigation of root cause through correction of the problem and prevention of recurrence. Best-practice forms can be used as is or customized.
• Centralized Repository: All CAPAs will be stored in a secure, centralized repository, making it easy to search and retrieve them during an FDA inspection or a quality audit.
• Advanced Tracking: MasterControl tracks CAPA tasks by status or history. A document will show as either "in process" or "complete" if tracked by status. The revision or approval history of documents can also be reviewed using the history feature.
• Analytics and Reporting: MasterControl's advanced analytics and reporting capability provides standard and customized reports. CAPAs can be summarized in multiple levels such as by product, department, and root cause. MasterControl includes dashboard and drill-down features. With its scheduling functionality, CAPA reports can be automatically sent to a user on a regular basis, or on specific dates in the future.
• Easy Access: MasterControl CAPA is Web-based so it can connect employees, suppliers, contractors, and others involved in corrective action processes regardless of location. Through the Internet, customers, vendors, and others outside the company can submit a form, such as customer complaint or product issue report, that could lead to a CAPA. Off-site and traveling users can also complete forms pertaining to the CAPA process without being connected to the MasterControl system. They can complete forms offline and then upload.
• Integration with Quality Processes: MasterControl CAPA seamlessly integrates with the change control, training, and other quality processes for a more efficient and effective system. For example, a CAPA that causes a change in product design or function will automatically invoke training tasks upon approval of the change, or a customer complaint serious enough to cause a CAPA will be automatically escalated.
• Form-to-Form Launching: A CAPA form can be launched directly from another form (i.e., customer complaint, audit findings, etc.) to streamline the CAPA process. Links are maintained so users can review a completed process and easily see what triggered the CAPA.
• Continuous Validation: For FDA-regulated companies, MasterControl offers a "continuous validation" approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative products and services include MasterControl Transfer OQ and MasterControl Automated OQ.
• Product Training: MasterControl's Professional Services team, consisting of former ISO auditors and system administrators, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. The team conducts training at MasterControl's state-of-the-art Training Center in Salt Lake City and also at customers' facilities.
• Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer's needs, from initial installation to regular maintenance.

• Integrates with Other Applications: MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.
• Simple Corrective Action Process Form: A CAPA may stem from different departments within an organization or even from outside (customers, suppliers, etc.). With MasterControl, initiating CAPA can be made simpler for everyone. A CAPA form can be configured to show the initiator only the relevant information to this step and to require completion only of fields related to data entry.
• Easy to Search: A standardized Google-like search window is available throughout the application, which means all authorized users throughout the organization can search and retrieve CAPAs and pertinent documents, as well as search for open CAPAs and related tasks.
• Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.
• Automation of Forms-Based Processes: Any forms-based process unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A department can keep the look and function of existing forms or create entirely new ones.