For many years, validating labeling processes has felt like an impossible mission for global medical device manufacturers, and has in some ways become a major barrier to the deployment of new systems for the fear of lengthy testing cycles and spiraling costs. Yet Label Lifecycle Management (LLM) is a mission critical ‘must have’ for life sciences organization that need to streamline processes, reduce labeling errors and mitigate risk.
It’s understandable that companies are cautious of change. The medical market is risk adverse in its very nature, no one can afford mistakes that threaten patient safety. Yet the move to newer labeling processes and methodologies offers real business gain that would mitigate such risks. So it shouldn’t be if LLM should be implemented, but how.
GAMP V (Good Automated Manufacturing Practice) sets out five key concepts to help medical device companies reduce the escalating costs of validation and improve compliance whilst bringing greater efficiency. These key concepts are:
- Product and process understanding
- Lifecycle approach within a Quality Management System (QMS)
- Scalable lifecycle activities
- Science-based quality risk management
- Leveraging supplier involvement
The latter concept, which encourages companies to take full advantage of supplier capabilities, is perhaps key. The guide advises that regulated companies should ‘maximize supplier involvement throughout the system lifecycle in order to leverage knowledge, experience and documentation, subject to satisfactory supplier investment’. It argues that suppliers could be well placed to help with requirements gathering, risk assessments and the creation of functional specifications, as well as system configuration, testing, support and maintenance.
The long-standing notion of ‘validation pain’ need no longer present a barrier to the introduction of LLM innovation. With the right supplier, validation is no longer an impossible mission, you too can transform your validation cycle to drive progress, productivity and profitability.