The implementation of new processes has to meet regulatory standards. Noviotissue is able to consult on applicable standards, implement processes and perform validations. We have experience with legislation in a number of geographical areas such as Europe, Canada, USA, Australia, New Zealand and several Asian countries. We have expertise on process validation, clean room validation, quality management systems such as ISO 13485 and industry standards such as AATB. Noviotissue can assist in performing the following projects:
- Process validations: Setting up a new process starts with setting up a validation master plan. Based on Noviotissue’s Quality Management System, we are able to support tissue banks with the plan and execution of the process validation to meet with applicable standards.
- Clean room lay out: The design of the processing room is critical for the process. With our expertise in the tissue banking industry we can rely on multiple years of experience in the design of clean rooms based on requirements and processing.
- Tissue handling: New methods to preserve, clean, disinfect and sterilize tissues are available due to continuous research and development. We are able to implement new processes and perform the validations to ensure the process conforms to standards.