Services
Below are some of the typical issues Efficacy works with:
Process Optimisation
Typical issues
- An ever-growing number of increasingly complex procedures, as rules are added piecemeal and new rules are introduced to fix production problems.
- The number of procedures and instructions each employee must follow keeps growing.
- Managing suppliers who have their own quality system and their own culture.
- Long lead times for changes.
- Unclear interfaces between production and other functions, e.g. R&D.
Quality Management System (QMS)
Typical issues
- New manufacturers must build a quality management system (QMS) from scratch, before the medical device is developed.
- Growing requirements for usability engineering and product risk management.
- Different levels of knowledge of GMP and design controls across the organisation
- Many stakeholders who each speak their own language, e.g. R&D, Production, QA, Regulatory Affairs, Clinical Affairs, etc.
Handling of Documentation
Typical issues
- Good documentation practice must be applied in the early development phases as well.
- Disagreement and uncertainty about how much formality is required at different points in the development process.
- Uncertainty about methods and templates for managing the Design and Development Files (Design History File)
- Uncertainty about the order of and relationships between the development documents
- Uncertainty about how to perform risk management
Participation in Projects
Typical tasks
- Effective and experienced project member.
- Project management.
- Coordination between the development function, Production, QA, Regulatory Affairs, Clinical Affairs, etc.
- Supplier management.
- Preparing project plans, risk management plans, verification plans, documentation plans, etc.
- Requirements specification and management.
- Risk management and risk analysis
