CAPA Programs - Corrective Action Preventive Action Programs

Automating Corrective Action Preventive Action (CAPA) Programs in FDA and ISO Compliance Environments

Recent reports show that 88% of FDA Warning Letters have been issued due to the failure of the corrective action program that a company has implemented. Corrective action software can help companies avoid the failure of a correction action or CAPA program.

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.

Watch Videos How MasterControl Makes Your Job Easier (3:50) Creating a Paperless Process Using MasterControl (3:38)

Things to Consider When Choosing a Corrective Action Program

With the increased convenience, reliability, and security of electronically managed documents, it is no wonder more and more companies are switching from outdated and inconvenient paper-based processes to a corrective action program that is automated. Here are a few things to consider when looking for CAPA programs.

• Does the application answer the end user's needs?
• Does the vendor have the domain expertise, adequate technical and financial resources, and philosophy to deliver a successful solution?
• Are the end user's evolving need and the developer's evolving development aligned so that the partnership will endure?

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:

CAPA Management Challenges		MasterControl CAPA™ Software System
Inefficient CAPA 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.
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. 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.

Corrective Action Preventive Action (CAPA) Program Features

Here's a summary of MasterControl CAPA's powerful system features:

• Automates Routing, Escalation, and Approval: Automates all CAPA tasks, including routing, notification, follow-up, escalation and approval. Automation helps sustain compliance by simplifying processes.
• Best-Practice Forms: Provides best-practice forms and workflow and is based on an "8D" process to guide the quality team through every step of CAPA implementation. The CAPA form can be configured to simplify the process of initiating a CAPA by showing the user only the relevant information and to require completion only of fields related to data entry.
• Revision Control: Automatic revision control ensures that only the current version of a document is available, so users will not make the mistake of using obsolete or unapproved documents.
• Analytics and Reporting: MasterControl CAPA MD provides standard and customized reports. CAPAs can be summarized in multiple levels such as by product, department, and root cause. MasterControl CAPA MD includes a 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.
• Part 11 Compliant Features: Provides time-stamped audit trail, reporting, and electronic signature capabilities required by FDA's 21 CFR Part 11 regulation. Security features include dual passwords for document approval, password expiration, encryption, and certification and account lockout to stop unauthorized users from gaining system access.
• Form-to-Form Launching: A CAPA form can be launched directly from another form (such as a customer complaint or deviation report), connecting one process to the next. Relevant data from a form are automatically entered into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Links are maintained so users can review a completed process and see what triggered a process.
• Anonymous Access: Through the Internet, customers, vendors, and others outside the company can submit a form (such as a customer complaint or product issue report) that could lead to a CAPA.
• Integrates with Training: Seamlessly integrates with the training process so a CAPA that causes an important change (in product design, SOP, etc.) will automatically invoke training tasks upon approval of the change.
• Offline Forms: Off-site users or external parties (customers or vendors) can complete a CAPA form, even without being connected to the MasterControl CAPA MD system. They can complete forms offline and then upload them.
• Document Approval via Form: A CAPA form and documents linked to it can be approved all at once, avoiding repetitive steps.
• Product Training: MasterControl's Professional Services team, consisting FDA industry veterans, ISO auditors, and IT professionals, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize faster software ROI. The team conducts training at MasterControl's state-of-the-art Education 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.