We received our ISO certification and FDA registration. However, our QMS is "overly heavy" in my opinion. Our scope heavily depends on the customer dedicating the cycle, the handling, packaging (which they provide), and a lot of aspects post sterilization. The interaction prior to setting up the project is key to success. We have gone with a e-QMS with records stored electronically. The system is able to operate with low labor requirements.
Any best practices, ideas or information that can be shared to reduce the amount of documentation for each cycle and remain complaint to ISO and FDA requirements?