MasterControl CAPA Pharma™ - Corrective Action System
Corrective Action Software for Helping Pharmaceutical Companies Automate CAPA Processes to Ensure Compliance with GxP Requirements
One area the FDA always scrutinizes during a facility inspection is a manufacturer's corrective and preventive action (CAPA) procedure. It's not good enough to just say you have a CAPA plan. You must convince the inspectors that your plan reveals what's really happening at your site. Winning them over requires providing significant amounts of documentation from many internal sources, including nonconformance reports and rejections, returns, complaints, internal and external audits, and management reviews. Managing or mismanaging these documents in a paper system can serve as a red flag for inspectors, possibly yielding a citation for violating current good manufacturing practices (cGMP).
MasterControl CAPA Pharma is a complete solution designed to help pharmaceutical companies automate and effectively manage the CAPA process and integrate it with their quality processes, such as change control, audit, training, nonconformance, and customer complaints. It allows staff to file all forms in one place, for easy review and retrieval.
Here's how MasterControl CAPA Pharma addresses some of the major challenges that companies face in implementing CAPA:
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MasterControl Corrective Action Software Solution |
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Inefficient System:
Manual CAPA systems are inefficient, requiring tremendous man-hours in terms of routing, obtaining approval and signatures. Finding documents in preparation for inspections and audits is also difficult and time-consuming.
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Efficient System:
MasterControl CAPA Pharma automates routing, delivery, escalation and approval of CAPAs and all related documents. It provides a centralized repository for all documents, making search and retrieval easy during inspections and audits. |
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Disconnected Processes:
A CAPA may be triggered by Form 483 or audit findings, customer complaints, or some other source. With manual systems, these sources are disconnected, making data collection slow, incomplete, or even inaccurate.
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Connected Processes:
MasterControl integrates the CAPA process with the rest of the quality system. For example, the resolution of a CAPA might trigger a change to a standard operating procedure (SOP) requiring retraining of employees on the new SOP. As another example of connected processes, a CAPA form can be launched directly from another form (such as a customer complaint or nonconformance) to streamline the process.
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Lacks Viability:
The lack of ability to track and monitor causes for CAPAs could result in delayed resolution of issues. Without a coherent reporting system, managers are unable to see the big picture of the quality management system. |
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Automatic Tracking:
The system tracks all routing information and data entered into the electronic form, allowing the CAPA owner to identify bottlenecks and understand the sequence of events during processing.
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MasterControl CAPA Pharma is an ideal solution for growing pharmaceutical companies who need an out-of-the-box, preconfigured forms system based on best practices.
Below is a summary of its key features and benefits:
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Automates Routing, Escalation, and Approval – Automates all CAPA tasks, including routing, notification, follow-up, escalation and approval. Automation helps sustain compliance by simplifying processes.
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Best-Practice Forms – Provides best-practice forms and workflow routes 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.
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Analytics and Reporting – MasterControl CAPA Pharma provides standard and customized reports. CAPAs can be summarized in multiple levels such as by product, department, and root cause. MasterControl CAPA Pharma 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.
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21 CFR Part 11 Features – Provides time-stamped audit trail, reporting, and electronic signature capabilities required by 21 CFR Part 11. Security features include dual passwords for document approval, password expiration, encryption, and certification and account lockout to stop unauthorized users from gaining system access.
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Web-based Platform - MasterControl CAPA Pharma is Web-based so it can connect all employees involved in the CAPA process from virtually anywhere.
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Integrates with Existing Repositories – Integrates with existing document repositories and enterprise applications like enterprise resource planning (ERP), laboratory information management systems (LIMS), etc. without expensive custom coding.
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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.
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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.
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Offline Forms - Off-site users or external parties (customers or vendors) can complete a CAPA form, even without being connected to the MasterControl CAPA Pharma system. They can complete forms offline and then upload them.
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Document Approval via Forms - A CAPA form and documents linked to it can be approved all at once, avoiding repetitive steps.
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Validation Flexibility - For FDA-regulated companies, MasterControl provides several flexible validation offerings and services to meet each company's individual validation requirements. These offerings dramatically cut the time, pain, and cost involved in validation to ensure continuous compliance.
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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 Training Center in Salt Lake City and also onsite.
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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.
About MasterControl
MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management. For more information, visit www.mastercontrol.com, or call 800-825-9117.
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