Quality & Compliance

In the Quality Assurance & Compliance area, we offer consulting services for:

• Deviation management, CAPAs
• Change Control Management
• Claim Management
• Audit management and support
• Management and review of procedures
• Provision and management of training and re-training for the qualification of personnel
• Drafting of protocols and reports
• Product Quality Review
• Management review
• Mock recall
• QAA revision

We supervise the Quality Systems of External Manufacturers.

In particular, this comprises:

• Drafting periodic reports on the performance (KPI) of External Manufacturers
• Preparation and review of documentation (e.g. Product Quality Reviews, investigative reports of process deviations and complaints, change controls, CAPAs)
• Drafting and periodic review of quality agreements with External Manufacturers.

We offer consulting services for:

• Management of requests to create, modify or deactivate finished and semi-finished product codes;
• Management of requests and creation of new Customer and Vendor master data;
• Management of activities for the introduction of new products (test execution, management of requests for the creation of new codes, creation or modification of codes, flow monitoring of regulatory data collection for material approval);
• Periodic monitoring of the state of completeness and approval of material codes for New Product Introduction (NPI) in accordance with the launch timing;
• Creation or modification of SAP objects related to the Global Supply Chain