Using TQM Software in FDA-Regulated Environment
FDA-regulated companies are required to implement total quality management software in accordance with regulations such as 21 CFR Part 211 (pharmaceutical companies), 21 CFR Part 820 (medical device companies), and 21 CFR Part 606 (blood establishments). TQM software designed for these companies typically address these regulations and related standards.
A voluntary recall of Tylenol children’s liquid products in 2010 shows how the FDA applies and enforces TQM principles. In a report pertaining to the recall, the FDA criticized the manufacturer for deficiencies in its TQM system. The FDA said that the responsibilities and procedures applicable to the manufacturer’s quality control unit were not followed. Almost all violations cited were related to the total quality management system.
This voluntary recall demonstrates that the FDA considers total quality control and a compliant TQM system as inherently integral to Good Manufacturing Practices, which manufacturers are required to follow. When evaluating Total Quality Management software solutions, be sure to look for features that address GMP regulations and standards.
Using TQM Software in Other Regulated Environments
In addition to FDA regulations, there are other regulations and standards that have resulted in the increasing use of TQM software. Many companies, especially manufacturers, adhere to these standards to acquire certification and to show their clients that they are compliant. Here some of the widely used international standards:
ISO 9000: Many manufacturers seek ISO certification to position their products and services in the global market more competitively. The ISO 9000 series for general manufacturers and other business is perhaps one of the most popular quality standards today. The series is composed of ISO 9000, ISO 9001, and ISO 9004.
ISO 13485: This quality standard applies to medical device firms. It provides a framework and specifies requirements for establishing a total quality management system, which is key to producing safe and high quality medical devices.
ISO 14971: This standard specifies a process for identifying risks in all stages of a life cycle of a medical device. It offers guidelines for controlling those risks and monitoring the effectiveness of the controls. While manufacturers can build their own TQM systems, most of them are taking advantage of TQM software designed for ISO and risk management compliance.
ICH Guidelines: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together regulatory experts and pharmaceutical industry experts from Europe, Japan and the U.S. This entity is responsible for more than 50 harmonized guidelines for new medicinal products that are widely applied worldwide. TQM software solutions targeting the pharmaceutical industry typically cover ICH standards.
MasterControl’s TQM Software Solutions for Regulated Industries
MasterControl Total Quality Management software solutions were designed to address the unique compliance needs and business challenges of life science and other regulated companies. MasterControl TQM system covers requirements that can be found in FDA, MHRA, and EMA regulations; ISO and GMP standards; ICH guidelines; and EU directives.
MasterControl offers the following TQM software solutions:
MasterControl Documents: This module automates and streamlines all documents-based processes, from routing to follow-up to approval. It provides robust document control capability, an essential requirement for any compliant TQM system.
MasterControl Process: One of the most popular MasterControl TQM software solution, MasterControl Process gives process designers to configure all aspects of workflows, including users, tasks, tracking, escalation, and approval.
MasterControl Training: An integral part of MasterControl TQM software, this module automates distribution and monitoring of training tasks. It provides the capability for online grading of tests and sequencing of courses, which means that upon completion of a prerequisite course, the next course in the sequence will be automatically launched.
MasterControl CAPA: This module offers industry best-practice forms that help reduce error in data entry. It streamlines the CAPA process by giving users the capability to launch a CAPA form another form, such as deviation or customer complaints.
MasterControl Audit: This module streamlines the audit process by automating all audit-related tasks and schedules. MasterControl’s advantage over other TQM software is its robust reporting tools and its capability to connect the audit management process with all critical TQM system processes.
MasterControl Supplier: Dubbed as a “one-stop shopping” solution, this module integrates supplier management with other critical quality processes within a total quality management system. Users can access all supplier quality data and documentation from a single repository. This TQM software solution provides the capability to create scorecards for effective evaluation of suppliers.
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