Services
Project Management
Project management (PM) is the planning, control, monitoring and completion of projects with the aim of achieving defined goals within a specified time, cost and quality framework. It includes all the tasks required to successfully manage a project from the initial idea through to completion.
Each RCA Bignami project is led by a dedicated project manager in close cooperation with our technical experts to perfectly synchronize organizational and technical processes, with the aim to comply with the customer’s objectives and achieve all project goals.
Validation Services
RCA Bignami is able to provide the complete portfolio Validation Services according to customer requirements such as the V-model if wanted.
Your equipment undergoes all necessary qualification tests in our factory before shipment. RCA Bignamie does not only carry out the Factory Acceptance Test (FAT), but also support you during the Site Acceptance Test (SAT) before the start of production.
At the beginning of the project RCA Bignami can prepare a structured Validation Master Plan (VMP) adjusted to your requirements.
During the Design Phase a Risk Analysis is executed and the pFMEA Document to identify, evaluate and minimize risks for product quality, which can result from the
processes on the machine is created for your appoval.
The results of the pFMEA are summarized by the pFMEA report and are the basis for the planning of IQ/OQ tests (Installation Qualification / Operational Qualification).
During the project all additional relevant GMP Documents can be provided, such as FDS (Functional Design Specification, HDS (Hardware Design Specification and SDS (Software Design Specification.
After Sales Service
At the end of each project after FAT RCA Bignami is supplying a Recommended Spare Part List incl. OEM parts and classification.
Technical support on site or remotely by RCA Bignami technicians is guaranteed during the full life cycle of the equipment.
RCA Bignami provides After Sales Service & Maintenance for all machines and Rotary tools delivered.
Resharpening of Rotary Cutting Dies will be done inhouse, also Cutting Dies from other suppliers can be resharpened if wanted.
Market & Products
Find out more about Medical & Pharmaceutical