Quality Management Systems Overview: Life Science Companies
In the life science industry, the U.S. FDA's regulations and guidelines reflect the importance of quality management in keeping medicines, medical devices, and other regulated products safe and effective. For general manufacturers, the ISO 9000 series provide a structure for compliance that leads to certification.
Any quality management systems overview for life science companies must begin with key regulations that the FDA enforces: 21 CFR 211 for pharmaceutical companies, Quality System Regulation (21 CFR 820) for medical device firms, and 21 CFR 606 for blood establishments. Meanwhile, 21 CFR Part 11 applies to the use of electronic records and electronic signatures by organizations that comply with the Food, Drug, and Cosmetic Act, the Public Health Service Act, and other FDA regulations.
Here is a QMS overview of the abovementioned regulations:
- 21 CFR 211: Under this regulation, pharmaceutical companies are required to establish and maintain a quality control unit, which is responsible for overall quality management systems and for providing an overview of a company's QMS needs. An essential part of quality management is documentation (procedures, SOPs, policies, etc.) and controlling all documents that impact product quality and safety.
- 21 CFR 820: This regulation requires medical device manufacturers to establish a quality system that covers critical processes such as document control, training control, deviations, and corrective action and preventive action (CAPA), among other things. When preparing a quality management systems overview (also known as QMS overview) for staff, the quality department should explain each process as it pertains to specific jobs and functions.
- 21 CFR 606: Current Good Manufacturing Practices for blood establishments, as embodied by this regulation, requires maintaining the safety, purity, and potency of the product. In providing a QMS overview, emphasize the importance of production and process controls, adherence to SOPs, maintaining quality control records, and reporting of product deviations.
- 21 CFR 11: This regulation applies to all FDA-regulated companies, such as pharmaceutical, medical device, biotech, blood, and biologics companies, and contract research organizations. Its overall goal is to allow the use of electronic records as much as possible, but at the same time ensure product quality. A quality management systems overview for Part 11 should cover these critical aspects: electronic records and electronic signatures. audit trails, validation, legacy systems, copies of records, and record retention.
Quality Management Systems Overview: General Manufacturers
The ISO 9000 series is perhaps the most widely used set of quality standards among general manufacturers throughout the world. The series is composed of ISO 9000, ISO 9001, and ISO 9004.
Here is an overview of some of the critical aspects of the quality management systems requirements under the series:
- The ISO 9000 series calls for the establishment of a QMS, which includes documenting, implementing, maintaining, and improving quality processes.
- It requires companies to develop and maintain QMS documents and records, including a quality manual.
- It requires companies to identify the resources they need and provide them accordingly, including providing competent personnel, as well as ensuring their continuing competence through training.
Quality Management Systems Overview: How MasterControl Can Help You
MasterControl quality and compliance software was designed to meet the unique needs of life science and other regulated companies. It is meant to facilitate compliance with GxP regulations (such as FDA, MHRA, EMA, and MHLW rules), guidelines (EU Annex 11 and ICH), and standards (ISO, EU GMP). Here is an overview of how it can help companies establish effective quality management systems.
- Accelerates Time to Market: MasterControl helps increase efficiency, optimize productivity, and accelerate time to market by automating all quality processes. It automates routing, follow-up, escalation, and approval of documents and forms. The system is web-based, so authorized users have access to the system from virtually anywhere 24/7.
- Accelerates Compliance: Automation helps facilitate regulatory compliance by making it easier for all stakeholders to participate in quality and compliance processes. Another key advantage of automation is standardization of documents and processes, which will facilitate audits and inspections. For more information about MasterControl's QMS overview, visit www.mastercontrol.com.
- Connects Quality Processes: MasterControl can connect all critical quality processes for a seamless quality management system. It provides a single, web-based platform for such processes as document control, audit, CAPA, training control, change control, risk management, supplier management, submissions management, and BOM management.
- Reduces QMS Cost by Using Cloud: For small companies with limited funds to invest in an electronic system, MasterControl provides cloud-based QMS. It offers the same robust and secure QMS without the large upfront cost of owning a system, the required IT infrastructure, and without the need to hire a full IT staff.
The following is a quality management systems overview (QMS overview) of MasterControl solutions:MasterControl Documents: For companies looking for a point solution that can serve as the centerpiece of their QMS, this module offers the most essential capability - document control - for switching from a manual process to a fully electronic system.MasterControl CAPA: This module automates and streamlines the CAPA process from start to finish. It offers industry best-practice forms that help reduce error in data entry and gives users the capability to launch a CAPA form from another form, such as nonconformance. For an overview of this module either as a stand-alone application or as part of bigger quality management systems, go to www.mastercontrol.com.MasterControl Training: This module automates distribution and monitoring of training tasks, as well as online grading of tests. It has the capability to sequence training, so a trainee who completes a prerequisite course will automatically get the next training. MasterControl Audit: MasterControl connects the audit management process with other critical quality processes. This module automates all audit-related tasks and schedules and provides robust tools for managing and conducting regular audits.
For More Information On Quality Management Systems (QMS) Overview
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