A quality management system (QMS) is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated QMS system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.
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The common quality management systems definition for the pharmaceutical industry stems from key regulations that the FDA enforces such as 21 CFR Part 211.
Under this regulation, a quality management systems definition would necessarily cover the concept of a quality control unit, which is responsible for overall quality management systems. The quality control unit is primarily responsible for documentation (procedures, SOPs, policies, etc.) and control of all documents that impact product quality and safety.
In addition to 21 CFR Part 211, the FDA guidance called “Pharmaceutical cGMPs for 21st Century–A Risk-Based Approach” provides principles and standards that will help pharmaceutical companies establish an organizational QMS definition. This guidance offers a quality systems model and shows how manufacturers can comply fully with 21 CFR Part 211.
The ICH Q10, a harmonized guidance for the pharmaceutical industry, also provides a good quality management systems definition by offering a model QMS based on ISO concepts and principles on Good Manufacturing Practices.
For medical device companies, the Quality System Regulation (21 CFR 820) offers a solid basis for a quality management systems definition. It is the primary FDA regulation for medical device companies. In as much as it helps manufacturers create their own organizational QMS definition, the regulation offers enough leeway for individual companies to define their priorities based on the device they are manufacturing.
Most medical manufacturers also adhere to ISO 13485, which similarly provides a quality management systems definition. The FDA has harmonized QSR with ISO standards, making them complementary.
Both QSR and ISO 13485 require the establishment of a quality management system that encompasses many quality processes, such as document control, training control, corrective action and preventive action (CAPA), and audit management processes.
MasterControl quality and compliance software was designed to meet the needs of life science and other regulated companies. It is meant to facilitate compliance with GxP regulations (FDA, MHRA, EMA, MHLW) and standards (ISO, European Union GMP). For MasterControl, a quality management systems definition encompasses the following quality processes:
Document Control: Hundreds of regulated companies worldwide use MasterControl Documents as the centerpiece of their quality management systems. MasterControl automates all documents-based and forms-based processes. It also automates day-to-day tasks such as routing, follow up, escalation, and approval of documents. It provides a centralized location for all documents and records, making search and retrieval easy.
CAPA Management: CAPA management is essential to any QMS definition. 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.
Training Control: MasterControl Training automates distribution and monitoring of training tasks and online grading of tests. This module has the capability to sequence training, so a trainee who completes a prerequisite course will automatically get the next training. Effective training is a necessary component of a compliant company’s quality management systems definition.
Audit Management: MasterControl Audit streamlines the audit process by automating all recurring tasks, including scheduling of audits, sending out assignments, and tracking tasks. This module provides best-practice forms for gathering and tracking basic information, as well as for tracking audit findings. It provides robust tools for managing and conducting regular audits.
Risk Management: MasterControl Risk standardizes the process for collecting and managing tasks pertaining to risk management. It automates review, approval, and execution of tasks. MasterControl also features analytics and reporting tools for faster and effective risk analysis.
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