Post-Launch Change Requirements
Developing web-based tools, initially focused on USFDA, which will enable life cycle management of devices, indicating when a significant change or like-for-like change is likely to be applicable, and giving advice and guidance on what steps and regulatory requirements to proceed with.
Inefficient and inconsistent
- Defining ‘like for like’ supplier change is unclear
- Hard to assess how substantial a change is
- New Regulations (e.g., EU MDR 117) and compliance of suppliers in question
- Inefficient and inconsistent processing change evaluations linked with how regulatory reporting requirements are decided
- Difficulties in providing suppliers and CMO’s with clear expectations, timelines and required information
- To enable decision-making process and allow all stakeholders to weigh up and consider all options: influencing long/short-term plans
- Including P-LCR consideration within the development of a Quality Agreement
- Ensuring appropriate resources are aligned with the process
- Standardize and streamline the P-LC process, with optimization of administrative tasks
- Align the process of working with suppliers, reducing reliance on individual personnel
- Time and resources saved
- Comprehensive check-list, especially useful for onboarding and training
- Increased innovation of existing products within the industry
- Ensure future production capability
- Sustainability improvements and considering raw materials used
Post-Launch Change Requirements deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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