FDA 21 CFR Part 820 Quality System Regulation

The intent of FDA 21 CFR Part 820 quality system regulation guideline is to clearly define the management of quality systems as it relates to the methods utilized in and the facilities and controls used for design, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of a medical product. In light of these regulations, software solutions have been developed to help companies subject to such intensive regulatory standards be better able to automate, simplify, and streamline quality processes according to industry best practices. The compliance benefits and time/money/resource savings provided by such software systems are innumerable. For instance, the efficient task assignment functionality and reporting capabilities offered by a proven electronic system help project managers accelerate and simplify project execution and allow them to better identify and eliminate bottlenecks. Integrated quality management also makes it possible for management to continuously monitor and improve quality systems.

FDA 21 CFR Part 820 quality system regulations mandate that documentation must be maintained and that changes in policy or procedure be recorded. Associated documentation, such as standard operating procedures (SOPs), quality manuals, design controls, CAPA information, change control records, employee training records, and similar documents are also included under the regulation. Quality management software (QMS) solutions dramatically simplify documentation processes by allowing organizations to manage all these types of documents under a single platform in a connected, secure repository. Electronic systems also automate routing and delivery paths as well as approval and archival procedures according to FDA 21 CFR Part 820 quality system regulation guidelines. In addition, obstacles that commonly occur during the development of a medical product (such as regulatory constraints, limited resources, and timely delivery of finished products) can be easily overcome with the right QMS solutions because the electronic systems dramatically increase overall efficiency. Solutions that are web-based offer the extra advantage of providing users that are geographically separated with an easily accessible centralized workspace and archive for document safe keeping, version control, and collaboration.

One of the most integral components of a quality system—especially in terms of how software solutions can help companies meet FDA 21 CFR Part 820 quality system regulations—is corrective/preventive actions, or CAPA. Subparts I and J of the FDA 21 CFR Part 820 quality system regulation mandate that all activities pertaining to CAPA and nonconformance be documented. An electronic QMS system simplifies CAPA processes because it automates all corrective/preventive action processes based on the input of complaints, incidents, audits, investigations, deviations, nonconformance, safety data, and so forth. An automated system should also be able to collect data from multiple sources, manage trends, and automatically trigger subsystem processes in order to solve production issues when—or even before—they arise. The software solution may also offer functionality that allows a CAPA form to be launched directly from another form (such as a nonconformance report). The system then directly enters relevant data into a CAPA form, thereby reducing data entry and eliminating errors that may otherwise occur during the manual transfer of such information. If the system is web-based, customers, vendors, and other authorized parties outside the company can submit forms (such as customer complaints) that could potentially lead to a CAPA. In a best case scenario, the entire quality management life cycle would be able to be monitored through the system’s reporting capabilities.

Training is also a vital component of compliance. In fact, Subpart B, Section 820.25 of the FDA 21 CFR Part 820 quality system regulation requires that every manufacturer’s personnel must have the necessary background, training, and experience, and that all training should be documented. Automated systems control and track role-based training requirements and employee competencies. Robust software systems make it possible for managers to electronically create and deploy training courses, plus they ensure that users actually learn their assigned duties to a degree that they are able to demonstrate proficiency. Exceptional systems offer features such as gap analysis, group signoff features, and automatic task generation every time a document (an SOP, for example) changes and a new training becomes necessary.

While technically not a part of the quality management system, validation is still critical to compliance. According to Subpart G, Section 820.70 of the FDA 21 CFR Part 820 quality system regulation, manufacturers must validate computer software for its intended use any time computers or automated data processing systems are used as part of production or the quality system. By law, all validation activities and results must be documented. With automated systems, all validation documentation is collected in a central repository and can be easily referenced at any time. Some systems even offer detailed prewritten installation qualification (IQ) and operational qualification (OQ) validation test protocols and scripts so a company can complete the validation requirements set forth in the FDA 21 CFR Part 820 quality system regulation on its own.

For more information about QMS software solutions and compliance with FDA 21 CFR Part 820 quality system regulations, contact a MasterControl representative.