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The path from discovery of a new drug to its actual delivery to patients is often long, bumpy, and costly. On average, it takes about 15 years of research and development at a cost of more than $800 million for a new medicine to obtain approval from the Food and Drug Administration (FDA). After approval, a company then begins to mass-produce its product, entering another expensive phase. It is estimated that it costs a pharmaceutical company $1 million in lost revenue for each day of delay in delivering a new medicine to market.
In order to stay on top of these intense business and regulatory demands, companies of all sizes are turning to the MasterControl family of off-the-shelf, configurable software products to automate and innovate document control and change management processes. In 1998, MasterControl Documents became the first document management software to enable pharmaceuticals and other FDA-regulated industries to meet FDA GxP requirements and comply with 21 CFR Part 11.
The FDA regulates the pharmaceutical industry according to a host of regulations, including the Current Good Manufacturing Practice (CGMP) outlined in 21 CFR Parts 210 and 211. Companies that maintain electronic record-keeping systems are covered by 21 CFR Part 11. Many pharmaceutical companies, especially those that market their products overseas, also conform to
ISO 9000 quality management standards. Public companies and those planning to go public are covered by Sarbanes-Oxley Act (SOX) requirements.
A pharmaceutical company's ultimate goal is to produce a safe, reliable, and effective drug. To achieve the goal of high quality, the company faces many challenges in different fronts, including:
- From research till the final phase of a New Drug Application, the pharmaceutical company must maintain rigorous documentation of quality management processes. Even after approval, the FDA may require ongoing studies. The challenge is to establish a secure, centralized, and efficient system for controlling documents-based processes and managing voluminous records generated by the R&D, clinical, manufacturing and technical services, quality, and regulatory departments.
- Many companies risk getting a Form 483 because of an ineffective Corrective and Preventive Action (CAPA) process caused by unreliable data from disparate sources and inadequate investigation due to lack of information and oversight.
- A change control process without the capability to notify affected parties (internal departments or external parties, such as CROs) in a timely manner, or the connectivity to invoke appropriate training upon approval of a change makes for a poor turnaround in change implementation.
- Using an electronic record-keeping system that relies on validation by expensive consultants or requires labor-intensive validation tests by internal staff will jeopardize the company's efforts to comply with 21 CFR 11.
The MasterControl™ integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance. MasterControl connects different departments with each other and with data and processes under a secure and centralized Web-based system. This connectivity helps promote quality throughout the enterprise by allowing management to continuously monitor and proactively improve the quality processes. MasterControl helps pharmaceutical companies meet key CGMP requirements and ISO quality standards, and at the same time increase efficiency and keep compliance costs down.
Roll over the list of solution categories below to view the related MasterControl product, then click to go to that solution's product page.
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.
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.
The MasterControl CAPA™ solution 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 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 control 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.
The MasterControl Audit™ solution 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 Submissions™ 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.
MasterControl Customer Complaints™ streamlines the complaint-handling process and reduce 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.
The FDA's 21 CFR Part 11 requires full-cycle validation of electronic record-keeping systems to assure the accuracy, reliability, and consistent intended performance of the system. MasterControl provides comprehensive validation services, including onsite IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) tests to ensure that the system is fully compliant. For companies wanting to perform their own validation, MasterControl offers a Validation ToolKit, which provides a detailed, pre-written validation test protocols and scripts.
For companies seeking compliance with the Sarbanes-Oxley Act (SOX), the 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.
For many small pharmaceutical and biotech companies, GCP stands for "Great Complicated Paperwork" rather than “Good Clinical Practices.� The voluminous paperwork is an integral part of meeting the international, ethical, and scientific quality standards for designing, conducting, recording and reporting trials that involve human subjects, but that doesn’t make it any easier to handle. Small contract research organizations (CROs) commonly feel overwhelmed by all the documentation required by the standard.
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