Quality Management Systems (QMS) - such as MasterControl's combined QMS Total Advantage suite of Quality Event Management, Document Control, Supplier Control, Training Control, and Quality Event Management (QEM) specific solutions of QEM Ready Set and QEM Tailor Fit - are the crux of any effective quality system. Investigations, corrections, and prevention are regulatory necessities that both FDA inspectors and ISO auditors consider singularly critical and can be easily managed from MasterControl QMS System.
Sélectionnez toutes les ressources que vous souhaitez télécharger.
MasterControl's QEM system is a polished system that fits any organization, regardless where the quality event originates. Whether 1) all inputs are run through a QEM system that acts as a "command central" and disposition to the correct process (complaint or other process) from that point, or 2) data is directly entered via specific entry points of a Channel Management system such as complaints, deviations, OOS, etc., and funnel directly into a CAPA Management system, MasterControl has a corresponding QEM solution that can harmonize with and enhance overall QMS processes.
MasterControl QMS System Packages are three separate solutions designed to meet the exact QEM and CAPA needs of any organization. Each system has been carefully constructed to bring maximum performance balanced with paying the right price for the right package.
Each MasterControl QEM System is designed to automate and effectively manage the CAPA process and integrate it with other quality processes, such as change control and customer complaints. MasterControl uses a foundation of excellence in Controls, Processes, and Competency as underlying core principles to guarantee that the system implemented will provide the compliance results the organization demands and the methods and skills to succeed. Each of these elements is carefully examined during the initial assessment and built into the early stage business report reviewed with management through MasterControl's QEM system.
The intelligent MasterControl Tailor Fit solution guides users through the CAPA process with the assistance of embedded coaching questions. The MasterControl QMS system includes a best-of-breed CAPA methodology and comes complete with initial assessment (business plan), best practices training, and consulting. MasterControl has teamed with PathWise Inc., an innovator in the development of compliance training programs. Each MasterControl QEM and QMS System package includes specifically tailored PathWise training for organizations that need to integrate software solutions in order to build competency as a part of core success strategy.
All MasterControl QEM or QMS System packages are built upon the best software platform in the industry. MasterControl quality solutions lead companies to faster resolutions by offering intelligent QEM Forms which address many of the major challenges that companies face in implementing CAPA:
QEM System Challenges
MasterControl QMS System Solutions
Many companies struggle to determine the actual root cause of a quality event and as a result end up addressing the same event over and over again within their CAPA process.
Effective Root Cause Determination:
Problem-solving algorithms and critical thinking logic are used 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. All these issues can be easily solved by just installing MasterControl QMS system.
Issues are evaluated based on their impact and frequency and the software system provides clear direction as to what the preventative and/or corrective actions should or should not be taken.
Manual QEM systems are inefficient, requiring an excessive amount of resources and time for searching, retrieving, routing and approving documents during inspections and audits.
The routing, delivery, escalation, and approval of each CAPA and all the related QEM forms is interconnected in the MasterConrtrol QEM system, making collaboration on key data very simple through each step of the process.
Disconnected QEM Tasks:
A CAPA may be triggered by an OOS, an NCR, audit findings, customer complaints, or a trend analysis. With manual AMS systems, these sources are disconnected, making data collection slow, incomplete, or, even worse, inaccurate. It becomes increasingly more difficult to determine what needs investigation.
MasterControl QEM solutions propagate 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.
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.
MasterControl QEM systems also make it easy to generate reports without IT involvement. Compare and contrast data over a large field of reporting options. The system can track all routing information and revision data entered into the electronic form, allowing the process owner to identify bottlenecks and monitor processing.
Efficient "Gateway Process": The risk filtering gateway process has been built into the MasterControl QEM Tailor Fit and Total Advantage QMS systems to provide unparalleled risk assessment capabilities. The gateway process provides users with a step-by-step guide within a risk assessment.
Streamlined Root Cause Investigation: The MasterControl QEM CAPA system guides users through the process for more efficient and effective root cause investigation. Should the cause already be known, intelligent links will skip past the investigation to immediate action and verification of action.
Best Practices QEM Training and Consulting: MasterControl has a world-class team of veterans with specific industry experience. They focus on a solution-based approach to solving problems for clients. Partnered with PathWise experts, the MasterControl team will train internal investigators on analytical problem solving and root cause analysis.
Automated Routing, Escalation, and Approval: MasterControl QMS system automates all CAPA tasks, including routing, notification, follow-up, escalation, and approval.
Analytics and Reporting: MasterControl's advanced analytics and reporting capability provides both standard and customized reports. CAPAs can be summarized in multiple levels such as by product, department, and root cause. The unique Event Cards allows you to compare complaints to audit findings to CAPA and any other input at a high level cross over view.
MasterControl QMS System Rules: Setting up rules-based tracking is a real advantage for trending when coupled with alarms that sound to notify the CAPA owner/manager of an out of trend situation.
Part 11-Compliant Features: All MasterControl QMS and QEM Solution forms provide time-stamped audit trails, reporting, and electronic signature capabilities.
Web-Based Platform: MasterControl QEM Systems is Web-based so it can connect all employees, vendors, customers, and anyone else involved in CAPA from virtually anywhere.
Training Integration: MasterControl's QMS Total Advantage System seamlessly integrates with the training process to ensure the appropriate parties are always current on important changes to product designs, SOPs, etc.About MasterControl QMS and QEM Systems
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 QMS system 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.