MasterControl Releases Next-Generation Corrective and Preventive Action (CAPA) Software Solution

SALT LAKE CITY - Dec. 8, 2005 - MasterControl Inc. today announced the release of a new version of its MasterControl CAPA™ solution, designed to effectively manage the Corrective and Preventive Action (CAPA) process and integrate it with other processes critical to regulatory compliance, such as change control, audit, and customer complaints, for a holistic quality management strategy.

CAPA â€" the overall effort to investigate and correct quality issues to prevent recurrence - is a requirement that both FDA inspectors and ISO auditors consider critical. When implemented properly, a CAPA system improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

A part of the MasterControl™ quality management suite, MasterControl CAPA seamlessly integrates with these recently released solutions: MasterControl Change Control™, MasterControl Audit™, MasterControl Customer Complaints™, and MasterControl Sarbanes-Oxley™. These solutions extend the enterprise-wide MasterControl solution â€" a platform powerful enough to meet an organization's different regulatory requirements.

MasterControl CAPA, launched in December 2004, provides best-practice electronic forms and workflow routes that can be used as is or customized according to a company's unique needs. It includes an "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem through corrective action. It provides a variety of customizable reports and the ability to dynamically capture, trend, and link data needed to solve problems.

With the latest enhancements, MasterControl CAPA strengthens an organization's ability to manage the process and also streamlines it for maximum efficiency. Here's a summary of the solution's new features.

Easy to Use:

•  To simplify the process of logging potential CAPA issues, the 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.

•  A standardized search window throughout the application makes it easy to retrieve completed CAPAs, as well as search for open CAPAs and related tasks.

•  MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool for finding documents quickly. Users can create virtual folders within Organizers that automatically retrieve documents based on a pre-defined query.


•  A CAPA form can be launched directly from another form (i.e., deviation report, customer complaint, etc.). Links are maintained so users can review a completed process and 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.

•  MasterControl is Web-based, so customers, vendors, and others outside the company can submit a form (i.e., customer complaint or product issue report) from virtually anywhere. Off-site and traveling users can also complete CAPA-related forms offline and then upload.

•  A CAPA form and the documents linked to it can be approved all at once, avoiding repetitive steps.


•  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.

•  Regulatory bodies are increasingly seeking proof of personnel competency through the use of testing. MasterControl offers the option to integrate CAPA with the training application for a more efficient system. For example, 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 even grading of online exams.

About MasterControl
MasterControl Inc. has been at the forefront of providing innovative electronic quality management systems since 1993. MasterControl provides comprehensive product training, technical support, and validation services. More importantly, MasterControl offers its customers something beyond software: a partnership that supports their compliance efforts in the long term. For more information, call 800-825-9117.