CO.RA. PROJECT MANAGEMENT SERVICES
CARE TO DETAILS - FROM THE CREATION OF THE MOST SOPHISTICATED PROCESS PLANT TO CONTINUOUS TECHNICAL SUPPORT AND ASSISTANCE TO MAINTAINING AN EFFICENT PRODUCTION.
During our almost 40 years of experience in terms of pharmaceutical processes, our attention to taking care of the details of each component or plant considers as a strong point the presence of technical support and specific consultancy for our customers, of which CO .RA. can boast.
We take care of the production process by listening to customer needs, the heart of the development of an effective technical solution, our goal is to contribute to the achievement of your production objectives, for this reason we are interested in knowing the characteristics of your products, carrying out the tests to verify the behavior of the product in contact with our machines and customize them to such an extent as to make them perfectly suited to production needs.
We are available for qualification audits and tests at our Technology Center which is always in operation for the experimentation of new possibilities for the design and operation of our systems,
The qualified technical team, in addition to providing support for choosing an effective solution, designs and manufactures integrated systems and components that are part of the production process.
Qualified technicians carefully follow the stages of construction of a machine taking into account the needs and facilities that the same machine can offer in terms of optimizing the quality of the operators' work and guaranteeing a satisfactory final result.
This means offering a 360° support guarantee, which consists of a wide range of services such as:
• Analysis and Verification of P&ID and Customer Technical Specifications;
• Meeting and technical inspections to define the project;
• Design and proposal of a Customized Technical Solution;
• Drafting of Specifications and Documents necessary for the realization of the project;
• Carrying out of Checks and Tests at CO.RA. Technology Center with customer products;
• Project validation (DQ), FAT at CO.RA. or in SMART SERVICES;
• Installation and SAT at the customer's site;
• IQ, OQ and PQ validation tests, Use and Maintenance Manuals complete with certifications;
• Process and systems engineering;
• Possibility of issuing GAMP5 (title CFR 21 part 11);
• TECHNICAL TRAINING for staff training on site or in SMART mode;
• Modification of modification requirements;
• Technical support for drafting SOP;
• Technical assistance on site or in SMART mode;
• Scheduled maintenance;
• Revamping of CO.RA. products;
• Management of complaints and reports of anomalies.
Starting from the analysis of the user's requirements specification, the team's goal is to find the best solution to meet the customer's needs and then focus on the development of the project, always ready to include any requested change request. The specialized know-how gained over the years of experience in solid handling, together with the innovative spirit, allows CO.RA. to provide its experience far beyond the supply of a simple plant.
CO.RA. guarantees its products, designed, built and qualified in compliance with the cGMP (Current Good Manufacturing Practice) principles and according to FDA regulations, thanks to consolidated and/or experimental technologies, technical expertise, reliability and collaboration: ingredients necessary to guarantee a high-level quality.