Product lifecycle in the life science industry refers to the entire process of product development, from design to commercialization. Product lifecycle management refers to managing the entire process in a compliant way. Over the years, life science companies have increasingly turned to electronic product lifecycle management solutions (or PLM solutions) to help them ensure compliance.
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The concept of product lifecycle primarily applies to medical devices, and PLM solutions available in the market today cater to device manufacturers. U.S. Food and Drug Administration (FDA) regulations and guidelines give consideration to the fact that the process of medical device development entails a cyclical and iterative process. It involves prototyping, testing and re-testing, and even re-design, before a device can be finalized. A robust product lifecycle management solution should address this cyclical and iterative nature of device development.
Regulatory bodies like the FDA greatly affect the device development process. Likewise product lifecycle management solutions are designed primarily to address existing rules and regulations.
For example, the FDA’s 21 CFR 820 incorporates requirements that ensure the safety and quality of a device in every phase of its development. Although these phases (pre-clinical, clinical, etc.) appear to be distinct, in fact they overlap. The FDA applies a “Total Product Life Cycle (TPLC)” approach in enforcement and it also maintains a TPLC database, which provides premarket and postmarket data about medical devices.
Medical device manufacturers are motivated to use product lifecycle management solutions because of the complexity of the development process, especially within the context of a total product lifecycle approach. An effective PLM solution can greatly streamline critical processes for every phase of the development and ensure a TPLC approach.
Most medical device manufacturers worldwide comply with ISO 13485 in addition to FDA and other country-based regulations. If they use a product lifecycle management solution, then the system must also address ISO requirements.
ISO 13485 requires medical device manufacturers to establish an effective quality management system, which would apply to the entire product lifecycle. While ISO 13485 implies the need for product lifecycle management, most device manufacturers apply those standards in conjunction with ISO 14971, which pertains to risk management. Companies looking for a product lifecycle management solution should make sure that the PLM solution they choose will address both ISO standards.
MasterControl offers a product lifecycle management solution for a more effective and efficient management of quality processes throughout the development process: discovery, prototyping, pre-clinical, clinical, regulatory approval, product launch, and post-marketing monitoring.
For more information about product lifecycle management (PLM) solutions, or the PLM software from MasterControl, please feel free to contact a MasterControl representative.