Is the quality of your products or compliance with key regulations critical to the success of your company? If so, then MasterControl QAAD™ is the perfect audit management software solution to meet all your quality and compliance needs.
MasterControl QAAD audit management software is the only off-the-shelf quality management solution that has been specifically developed for research and development quality groups in highly regulated companies. In the pharmaceutical industry alone, more than half of the top 20 companies have implemented MasterControl QAAD.
The MasterControl QAAD audit management software consolidates all relevant quality programs into a single comprehensive system. This allows validation and support efforts to be shared organization-wide. Fully validated according to U.S. CFR Part 11, MasterControl QAAD provides maximum flexibility without the need for vendor intervention, external consultants, or additional programming. The intuitive nature of the solution reduces training time, which results in a rapid return on investment at a remarkably low total cost of ownership. The "paperless" solution includes predefined workflows and core business processes that users can either modify or use “as is” to create completely new workflows. MasterControl QAAD also incorporates full electronic activity recording and distribution features, including response receipt and CAPA tracking. Data trending, metrics, and compliance surveillance tools are also integrated into the system, allowing users to accurately and continually monitor compliance status.
How Can the MasterControl QAAD™ Audit Management Software Benefit You?
The MasterControl QAAD audit management software can help you achieve and maintain regulatory compliance by automating, streamlining, and effectively managing quality processes. Here are some of the major quality challenges and how MasterControl QAAD is helping companies overcome them.
Key quality and compliance information is not centrally located Companies with multiple facilities and employees in different locations may initially find it less expensive to maintain separate systems. However, such systems do not enable a harmonized approach to the management of quality activities and are also limited in their ability to focus on problem areas across a company.
Information is centrally located to meet the needs of all quality groups MasterControl QAAD's central location provides the ability to focus on problem areas across a company. The product's flexible configuration capabilities can handle the requirements of all quality groups. Users can define as many business areas as needed to manage quality activities across an enterprise, whether the activities are QC, QA or QM-related. Permissions can be assigned so that individuals are granted access to all areas or only a number of areas, providing corporate or local oversight over all quality information.
Difficulties determining which suppliers are approved for a particular process or service
With manual or disconnected systems, users waste time and effort tracking supplier status or do not have key information on their suppliers in one location.
Supplier status and categories are electronically assigned MasterControl QAAD allows users to electronically assign approval status and categories to suppliers, giving appropriate personnel precise knowledge of what individual suppliers have been approved for. MasterControl QAAD also allows data on all suppliers to be recorded centrally and automates the tracking process.
Quality and compliance groups are not harmonized Communication breakdown is likely to occur when companies rely on disparate processes and tools to manage quality and compliance systems. Inevitably, this lack of harmonization can result in ineffective communications, delays, negative views of quality groups by customers, a non-uniform approach to processes and reporting methodology, and inability to effectively substantiate findings.
Quality and compliance processes are harmonized electronically MasterControl QAAD enables companies to harmonize quality processes, locally and/or globally. Users can standardize all key quality and compliance information, including findings, judgments, categories, CAPA, root causes, risk assessments, document templates, memos, letters, and activity workflows.
Manually-based audit reporting processes are time consuming, laborious
The more frequently audits are conducted, the more complicated it becomes to track correlated audit documentation. This results in quality and compliance personnel spending valuable time on mundane administrative activities instead of core responsibilities.
Reporting process is automated MasterControl QAAD can be configured to completely automate the reporting process. The system also provides electronic report signatures and actionable responses to reports.
Responses to quality reports are often late or not provided
Encouraging auditees to provide responses can be time-consuming. Quality groups spend a great deal of time and effort writing effective audit reports only to have their customers consistently not meet timeframes for responding. Manual methods for following up on late or missing responses take up valuable quality group resources.
Users are automatically notified of outstanding issues The product automates email and system messages (based on user-defined filters and periods) to notify responsible persons of issues that need their attention. This makes it unnecessary for managers to manually track and send reminders when responses or actions are late. The MasterControl QAAD solution's interactive Web-based response system ensures that those providing responses and actions are included in the overall quality process.
Difficulty determining which corrective actions are outstanding
Without adequate connectivity, critical information can slip through the cracks, potentially leading to unreliable findings in root cause investigations. Quality and compliance groups spend a great deal of time highlighting issues and what can be done about them. If these actions are not adequately managed and tracked, these efforts are meaningless.
Built-in tracking capability facilitates corrective actions Built-in action tracking functionality, for both corrective and preventative actions, simplifies, automates and expedites the receipt and follow-up of actions. A single screen gives authorized users access to all actions, and filters allow users to focus on particular areas of interest— e.g., by department, group, product, supplier, etc.
Inability to quickly identify critical compliance concerns
If critical issues are not addressed in a timely manner, risks are increased, and the potential to limit damage or take proactive steps is reduced. Diluting critical issues with minor messages is frustrating to those who need to take appropriate actions.
Critical issues can be electronically defined and accessed MasterControl QAAD allows the user to define which issues are critical to compliance and place more importance on such issues from a reporting perspective. Critical issues can be escalated and reported on at different levels and using different text. This ensures that appropriate personnel can easily identify issues and take appropriate actions. In addition, those responsible for taking action can elect to view only critical issues so that they can prioritize workload.
Obtaining information on quality and compliance issues is difficult
If a system's reporting tools are inadequate, users will not be able to determine problematic areas and procedures, or work proactively with customers.
Comprehensive reporting tools are incorporated into the system Comprehensive reporting tools allow users to access information on all quality and compliance data and focus on particular areas of interest. Data may be queried by company, site, department, supplier, or person.
Following up on compliance and quality issues is labor-intensive
Making assignments and following up on tasks via email or telephone is a time-consuming process.
Email messaging/escalation ensures prompt follow-up Follow-up functionality and automated email messaging for actions and responses, as well as escalation capability, maximizes efficiency for any task not completed by deadline.
Corrective and Preventative Actions (CAPA) are not connected
When the sources that trigger CAPAs are not connected, data collection is slow and incomplete.
Sources of CAPA triggers are standardized and electronically connected to expedite data collection MasterControl QAAD includes full CAPA functionality and allows users to standardize CAPA terminology and descriptions across and between all quality groups. This allows auditees to categorize actions, delegate them to appropriate personnel, and notify quality groups of actions that have been delegated.
There is no set escalation path for issues
Quality can be compromised when issues arise and there are no standardized protocols for delivering escalation messages to those who need to receive them. For sequential processes, this can mean a delay in incident resolution.
Escalation path is automated MasterControl QAAD automatically imports all quality issues raised anywhere within a company. Quality issues are managed until their closure according to user-defined procedures. MasterControl QAAD also incorporates email reminders and escalation, which, once set up, are completely automated.
There's no method for performing root cause analysis
Without predetermined methods of analysis it is not possible to identify and avoid bottlenecks in quality processes or proactively improve areas to minimize issues.
Root cause analysis categories are defined by user MasterControl QAAD provides the functionality for performing a root cause analysis according to user-defined categories. This allows evaluation and actions that ensure that processes are successful and continue to improve.
MasterControl QAAD Features:
Modularity: MasterControl QAAD provides specific solutions for all R&D quality groups, e.g., GLP, GCP, GMP, environmental, computer systems, and corporate oversight. Quality activities, processes, and workflows can all be defined using built-in tools. Discrete business areas can be created within a regulated discipline to separate similar functional groups. As much or as little data as is required may be shared within and between business areas. Users may be restricted to one business area or granted access to more than one business area (with the same or different roles).
Time Saving: The MasterControl QAAD solution helps companies realize significant time savings in planning, preparation, report writing, tracking, and follow-up activities.
Comprehensive, Yet Configurable: Each business area can be configured to provide as much standardization or flexibility as the organization needs. MasterControl QAAD has all the necessary tools built into the standard product. Users decide what features to use without having to purchase costly "add-on" options.
Translation Features: Built-in language capabilities allow users to translate dictionary data and display system field labels in their local language (single- or multi-byte characters).
Reporting Functionality: MasterControl QAAD users can create reports even if they lack intimate knowledge of the database schema. Custom reports are included with the system. All reports can be exported to Excel™ (Microsoft Corporation), Adobe PDF™ (Adobe Systems, Inc.) or CSV. Reports can be scheduled to run once, daily, weekly or monthly. Reports are viewable through the Web-based Response Entry Interface (QWBRE), which provides complete CAPA recording and tracking as well as automatic escalation features. Users can also record directly into the database.
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