For many years, validating labelling processes has needed a standardised best practice model for global medical device manufacturers, and has become a major barrier to the deployment of new systems because of long and expensive testing cycles.
Yet, Label Lifecycle Management (LLM) is mission critical for life sciences organisations that need to streamline processes, reduce labelling errors, mitigate risk and ultimately, reduce cost.
The medical market is risk adverse; no one can afford mistakes that threaten patient safety. Yet, the move to newer labelling technologies, despite the business risk, offers tangible mitigation of patient risk. The business case for LLM focuses on ‘how’, not ‘if’.
GAMP V (Good Automated Manufacturing Practice) sets out five key concepts to help medical device companies reduce the costs of validation and improve compliance through greater efficiency, including:
- Product and process assessment.
- Lifecycle approaches within a Quality Management System (QMS).
- Scalable lifecycle activities.
- Science-based ‘best-practice’ quality risk management.
- Leveraging supplier relationships.
The last point, which encourages companies to take full advantage of supplier capabilities, is key. Regulated companies should ‘maximise supplier involvement throughout the system lifecycle in order to leverage knowledge, experience and documentation, subject to satisfactory supplier investment’. Suppliers are well placed to help with requirements gathering, risk assessment and the creation of functional specifications, as well as system configuration, testing, support and maintenance.
The notion of ‘validation pain’ is all but eliminated. With the right partner, validation is no longer an impossible mission, and transforming your validation cycle to drive progress, productivity and profitability is now far more risk-free.
To learn more about GAMP V, LLM and risk free validation, click the button below: