We have senior consultants supporting multiple Medtronic locations in the US (Minneapolis, MN; Littleton, MA; Goleta, CA; Warsaw, IN; Jacksonville, FL). We support Medtronic for new product design & development, design assurance, manufacturing process validation and risk assessments.
We are currently assisting Shire to validate a variety of QC analytical equipment. The activities include Gap Assessment, 21CFR Part 11 assessment and conducting IOPQ.
We are implementing new hardware, servers, operating systems and database for their SAP infrastructure now. We have previously performed process validation and process improvements efforts as well.
Our team is involved in cleaning and process validation efforts for pharmaceutical manufacturing processes. We also assisted in the validation activities during the implementation of Tracelink.