Our approach can best be described as:
Customized, tell us what you really want…..
Many service organizations are excellent in designing new products, or, e.g., perform usability studies, clinical studies and more.
We want to be premium in world wide Quality Systems design and EU submissions.
Our services focus on the QMSR (13485:2016) transition, resulting in process based system design, including risk management optimization.
Our approach is also carefull…. not changing too many items at once. Train your staff so they can make educated choices. (Informed Staff can very well explain the system to any inspector.)
It all starts with the first contact, remote or on-site….
Let our experience help you.
Most Pharma companies have and use a quality system in the first place because it is a requirement. Part of the reason is because GMP did not start as a “Quality system”. Later GMP “extensions” have changed that to a more system like model.
For Pharmacompanies that have combination products the upcomming QMSR change (including the 14971:2019) requires a 100% quality system management…. Time for reconsidering your current QMS.
Most current Pharma systems we have evaluated are an “uphill struggle”. Many deviations and CAPA’s, costing nearly all quality effort, that could better be used for rethinking and redesigning your QMS processes.
It is time to experience the benefit from well designed quality systems…… from uphill to downhill.
Let us evaluate your current QMS and explore with you a more efficient future state.