MasterControl CAPA PathWise™ - CAPA Software with Best Practices and Consulting Services

Software for Automating Paper-based CAPA Processes and Ensuring Best Practice Implementation

Corrective and Preventive Action (CAPA) — the overall effort to investigate and correct quality issues and to prevent recurrence — is the crux of any quality system. It is a regulatory requirement that both global regulatory inspectors and ISO auditors consider singularly critical.

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

How Can MasterControl CAPA PathWise™ Software System and Best Practice Consulting and Training Services Benefit You?

MasterControl CAPA PathWise™ is a holistic software solution designed to automate and effectively manage the CAPA process and integrate it with other quality processes, such as change control, audit, training, nonconformance resolution, and customer complaints. The intelligent MasterControl CAPA PathWise system guides users through the CAPA process with the assistance of embedded decision mechanisms. The product includes not only a best-of-breed CAPA methodology but also comes complete with best practices training and consulting from PathWise. PathWise, an innovator in the development of compliance training programs for companies in life science industries, has developed proven analytical processes that help companies investigate root causes, perform corrective actions, check effectiveness, and prevent future problems.

MasterControl CAPA PathWise offers more than just data management. It leads companies to faster resolutions by offering guiding mechanisms that result in more effective decision points. Here’s how MasterControl’s intelligent CAPA PathWise solution addresses some of the major challenges that companies face in implementing CAPA:

CAPA Management Challenges		MasterControl CAPA PathWise™ Software System and Consulting Services
Recurring Issues Many companies struggle to determine the actual root cause of an issue and as a result will end up addressing the same issue over and over again within their CAPA process.		Effective Root Cause Determination The PathWise methodology uses problem solving algorithms to determine the actual root cause of issues – thus preventing them from recurring.
Death by CAPA Many companies do not have an effective mechanism to differentiate between critical and non-critical issues. Consequently, many issues are run through a full CAPA process that should have never seen the light of day. This results in increased costs because valuable resources were focused on the wrong problems.		Risk-based Filtering Issues are evaluated based on their impact and frequency and the system provides clear direction as to what the preventative and/or corrective actions should – or should not – be taken.
Inefficient Workflows Manual CAPA systems are inefficient, requiring an excessive amount of resources and time for searching, retrieving, routing and approving documents during inspections and audits. CAPA is too complex to effectively manage manually.		Efficient Automation The routing, delivery, escalation, and approval of each CAPA and all the related documents is provided through a centralized and interconnected repository - making it possible for key players throughout the organization to collaborate and apply analytical thinking to each step of the CAPA process.
Disconnected Tasks A CAPA may be triggered by an OOS, an NCR, audit findings, customer complaints, or a trend analysis. With manual systems, these sources are disconnected, making data collection slow, incomplete, or even worse – inaccurate. It becomes increasingly more difficult to determine what needs investigation and what does not.		Connected Quality Processes MasterControl CAPA PathWise propagates the CAPA process throughout the entire organization. For example, the resolution of a CAPA can trigger a change control that coordinates an SOP change and retraining of employees on that SOP. This connectivity also means that a CAPA can be launched from any valid source (i.e. customer complaints, nonconformances, etc.) to further streamline the process.
Lacks Visibility The lack of ability to track and monitor CAPA cases can result in the delayed resolution of issues. Without a coherent reporting system, managers are unable to see the big picture of their quality management system. What’s more, the reported data is frequently out of date.		Automatic Tracking The CAPA PathWise system tracks all routing information and revision data entered into the electronic form, allowing the process owner to identify bottlenecks and monitor processing. The system also makes it easy to generate reports without IT involvement.

MasterControl CAPA PathWise Features and Benefits:

• Efficient “Gateway Process”: The PathWise Gateway process has been built into the MasterControl CAPA system to provide unparalleled risk assessment capabilities. The Gateway process provides users with a step by step guide within a risk assessment, based on frequency and impact that reveals whether or not a CAPA issue is even warranted. This all takes place long before any preventive action or corrective action resources are committed.
• Streamlined Root Cause Investigation: The MasterControl CAPA system compares null hypothesis scenarios to come up with clues that lead to the most likely causes that can then be tested to determine the actual root cause. Users are walked through the process for more efficient and effective root cause investigation.
• PathWise Best Practices Training and Consulting: PathWise has a world-class team of veterans with specific industry experience. They focus on a solution-based approach to solving problems for clients. PathWise trains internal investigators on analytical problem solving and root cause analysis. The PathWise process goes beyond theory to teach practical application and“how-to” skills. When training is the appropriate solution, participants are actively involved in the learning process as they apply new knowledge to real-life case studies.
• Automated Routing, Escalation, and Approval: MasterControl automates all CAPA tasks, including routing, notification, follow-up, escalation, and approval. Automation helps sustain compliance by simplifying processes.
• 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. With its scheduling functionality, CAPA reports can be automatically sent on a regular basis or on specific dates in the future.
• Part 11-Compliant Features: MasterControl CAPA PathWise provides time-stamped audit trails, reporting, and electronic signature capabilities that fully satisfy 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
• Connected Systems: MasterControl connects the CAPA process with other quality processes for a “closed loop” approach to management.
• Web-based Platform: MasterControl is Web-based so it can connect all employees, vendors, customers, and anyone else involved in CAPA from virtually anywhere.
• Integrates with Existing Repositories: MasterControl CAPA PathWise integrates with existing document repositories and enterprise applications like ERP and LIMS without expensive custom coding.
• Form-to-Form Launching: A CAPA form can be launched directly from another form (i.e. customer complaint or deviation report), connecting one process to the next. Relevant data from one form can be automatically transferred into a CAPA form, reducing data entry and eliminating errors. Links are maintained so users can review a completed process and identify origins.
• Anonymous Access: Issues can be submitted anonymously via the Internet.
• Integrates with Training: MasterControl’s CAPA PathWise seamlessly integrates with the training process to ensure the appropriate parties are always current on important changes to product designs, SOPs, etc. Remedial training can also be triggered if that is determined as the root cause.
• Continuous Validation: For FDA-regulated companies, MasterControl offers a “continuous validation” approach that dramatically cuts the time, pain, and cost involved with validation. MasterControl’s continuum of innovative products and services include MasterControl Transfer OQ and MasterControl Automated OQ.
• 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. PathWise oversees all implementations and provides multiple avenues of support, including the generation or review of SOPs and work instructions, where needed.

About MasterControl
MasterControl Inc. is a global provider of GxP process, quality audit, and document management software solutions for life science companies. MasterControl™ products are easy to use, easy to deploy, easy to validate, and easy to maintain. They incorporate 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 currently use MasterControl solutions for easier compliance, faster validation, and better process management.

About PathWise
PathWise, founded in 1992, is a consulting and training firm that works with medical device, pharmaceutical, and biotechnology companies in the areas of quality and compliance. They provide quality system professionals with the methodology and tools to develop a quality system program that conforms to FDA standards, creating an action plan for success.  PathWise has offices throughout North America, with a client base that includes 3 of the top 5 Fortune 500 medical device and top pharmaceutical companies. Their staff holds faculty positions at the Association for the Advancement of Medical Instrumentation, Barnett International and PDA and regularly serve on boards and committees in various professional organizations.