Like other life science organizations, clinical and medical labs face stringent regulatory requirements that help to ensure the quality, accuracy, and integrity of test results and other laboratory data. Clinical and medical labs must comply with FDA regulations and the US Department of Health & Human Services' Clinical Laboratory Improvement Amendments (CLIA). Compliance with FDA regulations and the CLIA amendments can be easily ensured with the implementation and use of MasterControl's clinical laboratory quality control software.
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In order to help clinical and medical laboratories attain compliance with GxP standards, MasterControl provides clinical laboratory quality assurance software. The basic aim of this software is to integrate quality process management and to enable online cross communication between company departments. MasterControl is the leading pioneer in providing web-based solutions to companies that need to streamline their business processes and operations with a single web-based platform.
Clinical laboratory quality assurance software automates, streamlines, and effectively manages document control, change control, training control, audit management, corrective/preventive action (CAPA), customer complaints, and other quality processes. In order to help companies attain FDA compliance, MasterControl’s clinical laboratory quality assurance software provides validation tools and services. The entire validation solution is comprised of a combination of products and services that address different levels of validation needs. Organizations can either automate or manually validate their software solutions based on their risk assessment model. MasterControl's validation tools and services dramatically reduce the time involved in validating a system, reducing the risk of project implementation and making it easier to validate software upgrades, all of which help contribute to a lower cost of validation.
The MasterControl suite consists of the following integrated applications:
The biggest challenge faced by life science organizations including clinical and medical laboratories is inefficiency in their business operation units. Inefficiencies invariably hamper the effectiveness of a business's processes (and subsequently its products) and are not properly aligned and managed. MasterControl's clinical laboratory quality control software systems automate task assignments / routing, scheduling, follow-up, tracking, escalation, review, and the approval of all documents-based processes and connect the control of documentation with integrated business process controls. This helps in combining all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., for a closed-loop solution.
Quality assurance is a major part of testing, analyzing and observing processes in the system. This ensures that any deviation or nonconformity from the standard is immediately reported. The MasterControl clinical laboratory quality assurance and CAPA system interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. Moreover, the "8D" process guides the quality team through every step of CAPA implementation, from identification of the problem through corrective action. Since the software ensures integration between quality processes, a CAPA form can be launched directly from another form within the clinical laboratory quality assurance system (e.g, nonconformance or deviation report). Relevant data is automatically entered into the CAPA form that reduces data entry and eliminates errors from the manual transfer of information. As the clinical laboratory quality control & assurance software system is accessible anywhere through the Internet, customers, vendors, and others outside the company can submit customer complaints or other forms that could lead to CAPA.
Success of any company lies in how quickly it adapts to change. Any change in standard operating procedures must also be correctly documented and "trickled down" to reach employees without any delay. Change control features streamline the entire change control procedure for faster turnaround. MasterControl’s clinical laboratory quality control system offers best-practice forms that incorporate priority levels and prompt risk assessments and classifications of the change as low, medium, or high. Any high-level change implies a great impact on the product and is likely to require regulatory filing. This is where MasterControl Documents helps in documenting the change that eliminates the risk of practicing business by following outdated procedures in the system. Customizable reports in our clinical laboratory quality control software provide real-time quality system data.
The majority of life science companies spend valuable capital on hiring specialized teams of trainers to train employees about various aspects of the business. MasterControl's clinical laboratory quality assurance training system automates the assignment and monitoring of training tasks and the grading of online exams. It allows for the sequencing of training courses so that after a prerequisite course is complete the next one can be automatically launched. This helps in training large numbers of employees in training programs verified by the group sign-off feature. Training management can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change. Companies can allocate internal resources and save capital that can be used in other areas of the business.
Emphasis on compliance has enabled life science companies from across the globe to build their business so that it adheres to FDA regulations. Adherence to FDA regulations can lead to nonconformance events and severe consequences for companies. A critical eye for catching any anomalies is the basic requirement of any business. Because of this reason, MasterControl has devised a robust clinical laboratory quality assurance and nonconformance automation software solution that will automate, manage, and streamline a process for identifying, evaluating, reviewing, and handling nonconformance materials, components, parts and finished products. The solution's best-practice form and five-step process connects all responsible personnel for the effective and timely disposition of a nonconformance. Depending on the size of a business, the company can choose to maintain a standalone nonconformance process for small-scale, localized incidents, or may choose to connect it to the CAPA process, which will trigger automated escalations when the situation is warranted. The training solutions will automatically invoke training tasks upon approval of a document change (e.g, an SOP) or when specified by a training manager.
Companies that handle multiple and intricate kinds of procedures often require large amounts of documentation. Over time, it becomes increasingly difficult to maintain all of the documentation especially as a good portion of that documentation is updated and results in new document versions. This poses problems as multiple version of the same document are often left circulating among employees. The company may run the risk of a serious nonconformance event and may even have to temporarily shut down a specific manufacturing unit from production. MasterControl clinical laboratory quality control software solutions and audit management systems automate, streamline and effectively manage the audit process. It provides advanced tracking capabilities, from scheduling and planning to execution, completion and reporting. Apart from this, the advanced reporting feature helps in analyzing different dimensions of the business so managers can get a real-time view of the audit process.
Companies want to be able to process customer complaints in an effective manner so that a resolution of these complaints can occur without excessive delay. MasterControl's clinical laboratory quality control and customer complaints software streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. The solution provides a three-step process that starts with the processing of a customer complaint through the web-based portal, automatically moving to internal investigation and culminating with a resolution of the issue. In order to resolve issues, top-level management can generate reports and analyze the root cause of the problem with increased oversight.
MasterControl's clinical laboratory quality control software is a forms-based quality system which automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. One big advantage of the forms-based clinical laboratory quality control system is that it offers best practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to HTML, so users will see the same form and won't need new training. It is based on the discretion of the company to either improve existing forms or design new ones to suit specified company needs.
For more information about clinical laboratory quality control and assurance software systems, please feel free to contact a MasterControl representative.