Source: http://de.mastercontrol.com/21_cfr_regulations/21_cfr_part_820/quality_system_regulation.html?lne=lrel
Timestamp: 2017-05-29 23:06:11
Document Index: 590616312

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FDA 21 CFR Part 820 Quality System Regulation Software Designed to Meet FDA 21 CFR Part 820 Quality System Regulations Eliminates Manufacturers’ Compliance Pains
FDA 21 CFR Part 820 quality system regulations exist to make plain the Current Good Manufacturing Practice (CGMP) guidelines that pertain to the quality processes employed during the design, manufacturing, packaging, labeling, storing, installing and servicing of finished medical products. A variety of specialized software systems on the market have been expressly designed to facilitate medical product manufacturers’ compliance with FDA 21 CFR Part 820 quality system regulations, improve product quality, and accelerate time to market. The information presented here has been provided to help manufacturers understand what they should be looking for when searching for a quality management software solution that can help them achieve their compliance goals. Zugehörige Videos
Zum Inhalt How Can Software Improve Compliance with FDA 21 CFR Part 820 Quality System Regulations?
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. Benefits of QMS Software beyond Compliance
Robust electronic quality management systems integrate document and quality management with project management systems to help companies efficiently utilize and manage resources and accelerate a product’s time to market. By handling the legwork of document management and task tracking, QMS software makes it possible for project managers to focus on the technical components of projects rather than the administrative aspects. More information on FDA 21 CFR Part 820 Quality System Regulations
For more information about QMS software solutions and compliance with FDA 21 CFR Part 820 quality system regulations, contact a MasterControl representative at 801-942-4000. Links zum Thema
Compliance-Audit-Softwaresysteme21 CFR Part 606FDA-VorschriftenFDA 21 CFR Part 11FDA 21 CFR Part 1271FDA 21 CFR Part 820FDA 21 CFR Part 210-211FDA 21 CFR Part 111Softwaresysteme für die Einhaltung behördlicher VorschriftenReklamationsmanagement-Softwaresysteme FDA 21 CFR Part 820 Compliance21 CFR Part 820-SoftwareUSP 795 & USP 797 compliance