Significance of Quality Management Processes in FDA Environment
The U.S. Food and Drug Administration (FDA) enforces GMP regulations for pharmaceutical, medical device, blood and biologics, food, and other regulated industries. Those regulations call for the establishment of a QMS and the maintenance of quality management processes that should be properly documented and regularly reviewed or audited.
Among the GMP regulations enforced by the FDA, perhaps the two that have the greatest impact are 21 CFR Part 211and 21 CFR Part 820, both of which require the implementation of quality management processes.
21 CFR Part 211, which applies to pharmaceutical companies, cover every aspect of drug development and manufacturing, from personnel to processes to distribution. Records and reports are among the basic requirements of the regulation. In order to generate and maintain these records, pharmaceutical companies need quality management processes that are both compliant and efficient.
21 CFR Part 820 (Quality System Regulation), which applies to medical device companies, requires the establishment of controls in design, document, manufacturing, and production processes. It specifically calls for the implementation of quality management processes that are “appropriate for the specific medical device(s) designed or manufactured” by the regulated company. The FDA’s Medical Device Quality Systems Manual defines what constitutes an effective QMS, providing specific elements of a QMS model, such as management policies, objectives, documentation, etc. It also specifies the formal records that a medical device manufacturer must maintain through its quality management processes, such as design history files, device master records, device history records, and complaint files.
Quality Management Processes in ISO Environment
ISO 9001 standards are the most popular standards for manufacturers worldwide. These standards are voluntary, but even countries such as the United States, which enforce separate regulations, encourage manufacturers to follow these standards as a matter of good manufacturing and business practice.
ISO 9001 standards require the establishment of a quality management system, including quality management processes that are documented, controlled, implemented, and maintained.
In describing the elements of a QMS model, the FDA’s Medical Device Quality Systems Manual refers to ISO 9001QMS requirements as the “most comprehensive because it covers design, production, servicing, and CAPA activities.”
Medical device manufacturers that comply with FDA regulations will find it easier to comply with ISO standards and vice versa because the FDA has harmonized its Quality System Regulation with ISO standards, making them complementary. For these companies, ISO’s QMS model can provide a structure they can follow in establishing quality management processes.
Using MasterControl to Establish Compliant Quality Management Processes
MasterControl is an end-to-end solution that automates and connects all quality processes critical to compliance with FDA regulations, ISO standards, EU directives, and other regulatory requirements.
Using MasterControl as the foundation for your quality management processes will facilitate your compliance in all critical areas and help you with the following:
Document Control: MasterControl Documents is widely used by regulated companies as the centerpiece of a QMS that connects all critical quality management processes. It automates all documents-based processes, which greatly increases efficiency in routing, follow up, escalation, and approval of documents. It also provides a centralized location for all documents and records, making search and retrieval easy.
Training Control: MasterControl Training automates distribution and monitoring of training tasks, as well as grading of online exams. Training control can be integrated with other quality management processes so any change to a document or SOP or process that warrants re-training will automatically trigger training tasks upon approval of the change.
Audit Management: MasterControl Audit streamlines the audit process by automating all recurring tasks: scheduling of audits, sending out assignments, and tracking them. This module provides best-practice forms for gathering and tracking basic information, as well as for tracking audit findings.
CAPA Management: MasterControl CAPA automates, streamlines, and effectively manages the CAPA process. It provides best-practice forms and workflows, including “8D” process, to guide every step of a CAPA implementation. This solution is an integral component of a compliant QMS model.
For More Information on MasterControl Software
Please feel free to contact a MasterControl representative to answer questions you may have regarding quality and compliance software solutions.