Software to Automate Quality System Processes and Ensure Pharma Companies are in Compliance with CGMPs and 21 CFR Parts 11, 210, and 211.
In order to stay on top of 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 FDAGxP requirements and comply with 21 CFR Part 11.
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.
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 9000quality management standards. Public companies and those planning to go public are covered by Sarbanes-Oxley Act (SOX) requirements.
Quality Challenges
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:
Inefficient Quality System: Pharmaceutical companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections.
Disconnected Quality Processes:Quality processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA, training, and other quality processes is likely to cause delays in change implementation. A CAPA process that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information.
High Cost of Validation:21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a pharmaceutical company successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.
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.
What Solutions Are You Looking For?
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 efficiency and effectiveness of each department 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 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.
MasterControl QAAD™ audit management software 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.
MasterControl eMDR™ helps medical device companies electronically automate their adverse event reporting process in the confines of FDA/GxP environments including compliance with 21 CFR Part 11.
MasterControl DHF JumpStart™ helps medical device companies organize the myriad of drawings, notes, collaborative pieces,reports, and other documents that are created during the design process. Device companies want a tool that bridges the gap between design and manufacturing and provides project management, design control processes, and document control and approval. MasterControl DHF JumpStart meets their desires, point for point.
MasterControl Bill of Materials™ (BOM) streamlines the handling of BOMs and helps companies overcome common BOM-related predicaments.
MasterControl Supplier™ software system to automate supplier management and supplier compliance in FDA and other manufacturing environments.
A.P. Pharma
