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MasterControl Inc. Offers New CAPA PathWise Solution

12-03-2008 09:51 AM CET | IT, New Media & Software

Press release from: MasterControl

SALT LAKE CITY, UT, USA – December 2, 2008 – Today MasterControl Inc. announced the availability of its comprehensive CAPA PathWise™ solution. MasterControl, a global provider of GxP process management software solutions, has developed the new automated solution with PathWise, Inc., a consulting and training firm that specializes in quality and regulatory processes for life science industries.

MasterControl CAPA PathWise™ is a holistic software solution designed to automate and effectively manage the corrective and preventative action (CAPA) process and integrate it with other quality processes, such as change control, auditing, training, nonconformance resolution, and intelligence-mining from customer complaints.

“The intelligent MasterControl CAPA PathWise system guides users through the CAPA process by embedding decision mechanisms into electronic forms that drive the process,” said 12-year manufacturing veteran Oliver N. Wolf, who is the lead Solutions Project Manager for MasterControl. “The product includes not only a fully automated best-of-breed CAPA methodology but also comes complete with best practices training and consulting from PathWise.”

PathWise, Inc. has been heralded as a leading innovator in life sciences for their development of analytical processes that identify root causes, define appropriate corrective actions, analyze effectiveness, and prevent future problems. PathWise has a world-class team of veterans with specific industry experience. They focus on a solution-based approach to solving problems for their clients. PathWise trains internal investigators for companies that want to implement an intelligent CAPA system. PathWise trainers teach practical skills that lead to real-time solutions.

“The PathWise methodology uses simple algorithms to determine the root cause of complex issues, thus preventing them from recurring,” said Ken Peterson, PathWise founder and CEO. “MasterControl CAPA PathWise offers more than just automated data management. It leads companies to faster resolutions.”

MasterControl CAPA PathWise propagates the CAPA process throughout the entire organization. For example, the resolution of a CAPA could trigger change control in engineering, editing an SOP in production, and retraining employees through human resources. This connectivity also means that a CAPA can be launched from any valid source such as customer complaints, nonconformance reports, vendor audits, etc., to further streamline the process. The system allows users to evaluate issues based on impact and frequency and provides clear direction as to what preventative and/or corrective actions should – or should not – be taken.

The routing, delivery, escalation, and approval of each CAPA – and all the related documents – is provided through a centralized and interconnected repository. This makes possible for key players throughout the organization to collaborate and apply analytical thinking to each step of the CAPA process.

The MasterControl CAPA PathWise solution also:

• Automatically tracks all routing information and revision data entered into an electronic form, allowing the process owner to identify bottlenecks and monitor progress.
• Makes it easy to generate reports without IT involvement.
• Uses the built-in PathWise Gateway process 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.
• 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.
• Automates all CAPA tasks, including routing, notification, follow-up, escalation, and approval. Automation helps sustain compliance by simplifying processes.
• Connects the CAPA process with other quality processes for a “closed loop” approach to management.

Other features and benefits of the MasterControl CAPA PathWise solution include:

• Robust analytics and reporting capabilities
• Part 11-compliant features
• Web-based platform
• Integration with existing repositories
• Form-to-form launching
• Anonymous internet access
• Seamless integration with the training process
• Continuous validation
• Expert technical support and consultation

6322 S 3000 E
Suite 110
Salt Lake City, UT 84121
Jason Clegg

About MasterControl Inc.
MasterControl has been at the forefront of providing document management and GxP process solutions to life sciences companies since 1993. Hundreds of companies around the world rely on MasterControl to automate and effectively manage document control, change control, audits, BOMs, corrective/preventive actions (CAPA), training, nonconformance disposition, customer complaints, and other GxP processes. The MasterControl solution is easy to use, deploy, validate, and maintain. MasterControl incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance with requirements such as ISO standards, FDA regulatory requirements, and similar regulations. 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. For more information, visit the MasterControl website or call 800-825-9117.

About PathWise
PathWise Inc., 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. PathWise provides 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 three of the top five medical device and top pharmaceutical companies listed in the Fortune 500. Their staff holds faculty positions at the Association for the Advancement of Medical Instrumentation, Barnett International and PDA and regularly serves on boards and committees in various professional organizations. To learn more about PathWise training, connect to PathWise at or call 866.580.PATH.

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