The concept of “product lifecycle management” (PLM) is associated with manufacturing in general, but it’s also an important aspect of compliance for industries under the jurisdiction of the U.S. Food and Drug Administration (FDA), or other global regulatory bodies. The key to effective product lifecycle management is ensuring product quality, from conception to marketing. The complexity of such a requirement has given rise to the popularity of product lifecycle management products (PLM products) designed to automate and simplify PLM processes and activities.
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Perhaps the most popular PLM products available in the software market today are geared toward medical device manufacturers because of the nature of the development process for devices, which is inherently iterative and cyclical.
Most software providers design PLM products to address regulations such as the FDA’s 21 CFR Part 820 (Quality System Regulation), which covers device design, manufacturing, training, device installation, and reporting of complaints after the device is launched in the market.
The importance of PLM is highlighted by an FDA draft guidance specifically targeting infusion pumps. The 2010 guidance (“Total Product Life Cycle Infusion Pump – Pre-market Notification (501k) Submissions”) was prompted by a spate of product recalls of defective infusion pumps. This guidance reflects FDA thinking about PLM and is a good indication of what a robust product lifecycle management product should provide. In evaluating PLM products, medical device firms should choose a PLM system that addresses the issues outlined in the guidance.
Just like medical devices, developing and manufacturing medicines is a highly iterative process, from scale-up to commercialization. PLM products geared toward pharmaceutical companies typically address FDA regulations and other quality standards that require control of processes and documents throughout the product lifecycle.
Regulations (e.g., the FDA’s 21 CFR Part 211) require pharmaceutical companies to establish a quality management system in order to strengthen the links between lifecycle stages. This is one way to ensure product safety and quality. An effective product lifecycle management product should take into consideration the following elements: controlled environment for managing product information, ability to track product data, and visibility of complete product records.
The main goal of a robust and effective PLM product for pharmaceutical companies should be the same as the goal of regulations that the companies are complying with—consistent production of safe drugs.
Using an electronic PLM product is no longer a luxury but a necessity for most medical device, pharmaceutical, and other regulated companies. MasterControl quality software has set itself apart from other product lifecycle management products in the market today by ensuring compliance and efficiency throughout the product lifecycle. Here are some of the benefits of using MasterControl:
Efficiency through Automation: MasterControl helps increase efficiency and accelerate time to market by automating all quality processes. It automates routing, follow-up, escalation, and approval of documents and forms. The system is web-based, so authorized users have access to the system from virtually anywhere 24/7.
Accelerates Compliance: Regulated companies use PLM products primarily for compliance purposes. MasterControl helps accelerate compliance by making it easier for all stakeholders to participate in quality and compliance processes. MasterControl also standardizes documents and processes, which facilitates audits and inspections.
Connectivity throughout Product Lifecycle: Connectivity is a mark of a robust PLM product. MasterControl can connect all critical quality processes for a seamless quality management system. It provides a single, web-based platform for such processes as document control, audit, CAPA, training control, change control, risk management, supplier management, submissions management, and BOM management.
To learn more about MasterControl’s quality and compliance software, please feel free to contact a MasterControl representative.