Integrated Quality Management Software
Features & Benefits
for the Biotechnology Industry
21 CFR Part 210-211 Compliant Quality Management Systems
Some of the most advanced medicines and vaccines that exist today were developed by biotech companies. Given the complexity of the biotech field, these companies face strict regulations, such as the GMP requirements found in the FDA's 21 CFR Parts 210-211.
The MasterControl integrated quality management suite is a configurable, off-the-shelf, and easy-to-use software solution that facilitates FDA compliance. It integrates different quality processes and connects different departments involved in the compliance initiative. MasterControl automates, streamlines, and effectively manages document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other forms-based quality and business processes under a single Web-based platform. For companies seeking compliance with the Sarbanes-Oxley Act, MasterControl offers a complete solution for managing SOX processes.
In addition to providing robust software, MasterControl offers cutting-edge validation tools and services that will help ensure FDA compliance. The MasterControl Validation Solution consists of a continuum of products and services that address different levels of validation needs. It gives companies the choice of either automated or manual validation services based on their risk assessments. The solution dramatically cuts the time involved in validating a system, reduces risks of project implementation, and makes it easier to validate software upgrades, all of which help lower validation cost.
The MasterControl suite consists of the following integrated applications:
MasterControl Documents helps increase the quality unit's efficiency and effectiveness by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy. MasterControl Documents, the core application in the MasterControl quality management suite, integrates all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., for a closed-loop solution.
The MasterControl CAPA system interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. It includes a best-practice 8D process to guide the quality team through every step of CAPA implementation, from identification of the problem through corrective action. A CAPA form can be launched directly from another form (e.g., nonconformance or deviation report), automatically entering relevant data into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Through the Internet, customers, vendors, and others outside the company can submit customer complaint or other forms that could lead to CAPA.
MasterControl Change Control streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change implies great impact on the product and is likely to require regulatory filing. Customizable reports provide real-time status not only of change control tasks but of the entire quality system.
MasterControl Training automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. Training management can be integrated with the rest of the quality system, so a ny change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
MasterControl Nonconformance is a robust solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. This solution offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it. training will automatically invoke training tasks upon approval of the change.
MasterControl Audit automates, streamlines, and effectively manages the audit process. It provides advanced tracking capability, from scheduling and planning to execution and completion. MasterControl offers best-practice forms for tracking basic audit information and audit findings. It automates scheduling of all recurring audit-related activities and provides advanced analytics and reporting capability, so managers get a real-time view of the audit process.
MasterControl Customer Complaints streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue. MasterControl's advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. MasterControl is Web-based, so customers can submit complaints from virtually anywhere.
MasterControl Forms automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. This solution 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 PDF as is, so users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs.
MasterControl Submissions Gateway facilitates electronic delivery of FDA applications (such as IND, NDA, and BLA) by providing control in assembling and tracking necessary documentation. It provides appropriate templates to streamline the dossier-creation process. MasterControl can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process, to accelerate submissions.
For companies seeking compliance with the Sarbanes-Oxley Act, MasterControl SOX? is a complete and easy-to-use solution that automates and effectively manages business processes, including voluminous documents, records, and SOPs. It includes a pre-configured form that documents and collects data pertaining to risks, internal controls, and tests. It links every risk with its control and test through pre-built workflows. It allows testing to be automatically scheduled and incorporates escalation to ensure that tests are completed.
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Creating a Paperless Process Using MasterControl
