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.