MasterControl: A QMS to answer 21 CFR

MasterControl: A QMS to answer 21 CFR Samuel Warren IS472: IT Compliance Professor Steve O’Brien November 20, 2012 MasterControl: A QMS to answer 21 CFR Executive Summary Regulating and maintaining compliance in the biotechnology, pharmaceutical, and genetic engineering fields is quite a task. In order to maintain compliance with FDA required 21 CFR, many companies are choosing to turn to quality management systems as answers to deal with compliance. The beauty of this is they do not have to figure out how to comply with the regulations; they simply have to learn the proper way to interact with the software. Master Control makes one such software; with its features and integration, the MasterControl suite of products is one of the most robust QMS platforms that have been created. If utilized correctly, it will enable companies to do more research and spend less time trying to maintain compliance. Introduction What is quality? Is it an end state? Is it a process? Quality is all of the above. It is an end state, a process, and even a descriptor. When discussing quality with individuals, there is a somewhat vague, generalized answer floating to the forefront most often. That answer oftentimes describes the characteristics of a product or service as “reliable” or “stable.” While both definitions are generally acceptable, defining quality can be much larger and involve a fair amount of compliance to regulatory demands. The Quality Management System (QMS) described herein will have its benefits fully explained and enumerate the way it will contribute to the compliance requirements. What is MasterControl? MasterControl is a product suite created by Master Control Incorporated with the purpose of aiding in quality management services with specific regards to FDA and other regulatory compliance issues. With a host of offerings, ranging from Quality Management to Training Management, it is meant to provide a managed answer to how to achieve and keep an organization in compliance within 21 CFR, and other FDA required compliance fields. According to Master Control’s “Software Control Solutions Overview”: While market globalization has vastly increased the profit potential for manufacturers and other businesses, it has also intensified competition and the pressure to produce faster and at a lower cost. The situation is doubly challenging in a regulated environment (FDA, EMEA, etc.), where companies must contend not only with cutthroat competition, but also stringent regulatory requirements. (2010, p. 1) With such a highly competitive field and risky potential failures, it is imperative that organizations do everything they can to grease the skids and provide easier access to auditors and regulators in order to prevent being either considered noncompliant or non-cooperative. The MasterControl suite provides governed and trusted software and systems to help ensure the organization can focus on the fewest possible technology problems, it also frees up the companies to engage in more research and discovery. How to Optimize MasterControl It is essential for all systems to be optimized. QMS’ are not exempt from that necessity. Without optimization, the users are unable to best utilize the system to its fullest potential. When approaching the optimization of MasterControl, there are several significant areas to contemplate. One recommendation is to eliminate the muddled mix of digital and analog. This is too costly for the company to invest in the computer systems, not to mention the costliness of paper, ink to print and copy, and maintenance on the devices, depending on the size of the company. Another hidden cost is the time investment for audits or inspections. A routine GMP inspection typically lasts a week, but sometimes they can last up to five weeks. The investigator noted that within this context, an electronic record-keeping system could make all the difference in speeding up the inspection process. (“Six,” 2010, p. 2) While a week is not a long time for the auditor, they may spend time consuming internal resources and, in some cases, may stop work altogether. The end cost could be much higher than anticipated if the inspection or audit lasts longer. Another major way to optimize the QMS is to use different software and processes that connect together well. MasterControl provides such a large suite of software, all of which are interconnected, and all of which are fully digital. It has the ability to integrate with electronic repositories that are good for storing SOPs, engineering drawings, and other documents, but are incapable of controlling quality processes like training and CAPA. MasterControl allows companies to leverage their existing repositories by integrating them with robust MasterControl applications without expensive custom coding. (“Six,” 2010, p. 3) By having and maintaining connections to the electronic repositories, the MasterControl suite is able to have a wider reach digitally and reduce the potential disconnection points where the people and outdated processes connect to the system, thereby limiting the risk of system failure. How Does MasterControl Enhance Compliance Efforts? A major area MasterControl excels in is aiding in compliance efforts. With such tightly controlled fields, manually verifying compliance would be time consuming and potentially very expensive. By using a system like MasterControl’s suite, there are five areas accounted for: “system standard operating procedures, user authentication, access security, audit trails, and record retention” (“5 Ways,” 2010, pp. 1-4). All the areas are vital to maintaining a compliant lab, or business overall. The whitepaper written by Master Control Inc. provides quite a bit of detail for each item. For example, in user authentication, they describe the following MasterControl software features: MasterControl has numerous levels of security to ensure authenticity of each user in the system. The software tracks every signature combination and does not allow duplication or reassignment of the user ID and signature combination. Each user establishes a signature password upon first log in. He or she first logs into MasterControl with a user ID and a password just to gain access. To sign off on any document, the user must use a different “approval” password. All user IDs and passwords are encrypted and are not available to anyone in the system. (“5 Ways,” 2010, p. 3). The aforementioned security levels help to define and regulate how users interact with the QMS. However, they also provide a robust system control scheme enabling direct fulfillment of 21 CFR regulations for said area. While there are many more features of MasterControl’s products, this particular area serves as a poignant reminder of just how much detail was actually placed into MasterControl software. References 5 Ways MasterControl helps ensure system compliance with 21 CFR Part 11. (2010). MasterControl Inc. Retrieved November 19, 2012 from the World Wide Web: http://www.mastercontrol.com/resource/index.html#wp Six ways to optimize your quality management system and ensure FDA and ISO compliance. MasterControl Inc. (2010). Retrieved November 19, 2012 from the World Wide Web: http://www.mastercontrol.com/resource/index.html#wp Software control solutions overview. MasterControl Inc. (2010). Retrieved November 19, 2012 from the World Wide Web: http://www.mastercontrol.com/resource/index.html#wp