We check your manufacturing processes and their accompanying processes such as training management, CAPA structure and change management in the medical device as well as pharmaceutical/aseptic environments for gaps in the process and manufacturing process and manufacturing documentation and propose solutions to close these gaps.

Gaps, also with regard to past or upcoming critical audits.

In particular, we check your manufacturing processes with the respective accompanying processes within the scope of audit preparation for the requirements of the MDSAP specifications. We also support you in the audit execution and the corresponding audit follow-up.

We review your risk management processes and moderate FMEA workshops for you, including preparation and follow-up for new processes to be developed, changes to existing processes or as part of a retrospective review of existing manufacturing processes in the medical device and pharmaceutical/aseptic environment.

We review the technical documentation of your IVDR products for gaps and propose solutions to close these gaps in compliance with IVDR 2022.

We support you in creating and defining or reviewing user requirements as part of the approval process when planning the construction or conversion of a cleanroom complex.

We verify the plausibility of the process parameters of your manufacturing processes, which have a quality-specific influence on your products.

We support you in the planning and implementation of qualification projects in the area of your manufacturing processes.