Since the introduction of the "design controls" in 21 CFR part 820, the FDA has the right to conduct more detailed inspections regarding the development of processes and documents. As a result, many companies complain that they are required to produce an excessive amount of documentation. In addition, processing times are longer and development costs are rising.
With Capamed, there is another way...
Capamed has integrated the latest improvements into the existing processes in order to comply with the FDA regulations without incurring additional costs and delays due to "FDA compliant" development procedures and processes.
Our 3-Step Approach:
- Evaluation of the current practices for product development. Deviations from the required processes, as well as inefficiencies in the development process are analyzed.
- Modification of existing procedures and processes in the quality system documentation.
- Implementation of improved processes through training and fine-tuning of procedures with affected employees. We support specific development projects and jointly develop reusable patterns for your product documentation.
The Capamed Advantage:
- Efficient product development according to FDA and EU regulations
- Development of a motivated and competent staff