Management Plan

Preliminary milestone schedule

Project Approach

  • Issue of the project quality plan
  • Continuous contact and interface with the customer
  • Project engineering decisional meetings plan:
  • Proposal for the 1st meeting, for the presentation of the project documentation for comments and approval;
  • Proposal for the 2nd meeting in Italy as a final one before the production of the critical components
  • FAT plan (we have foreseen n°2 FAT with presence of Client
  • SAT and commissioning
  • IQ and OQ (preparation and execution, documentation for review/approval issued upfront)
  • Handover to customer
  • Post sales assistance and support– (monitoring system + tele assistance system + telephone assistance + internet assistance)
  • Ad hoc visits (one per year) included into the scope of work (1 specialist on site per 2 days) during guarantee period

2000

Manufacturing Area (mq)

500

Testing Area (mq)

83

Talent staffs

Over

500

Clients

Project Management Steps

  • Contract review
  • Organization and planning
  • Meeting to launch the project
  • Drafting of the PQP (project quality plan)
  • Kick off meeting with the Customer
  • Monitoring the application of the PQP
  • Execution of quality actions
  • Conduct of the project
  • Design reviews during project development
  • Management of internal and external resources (sub-contractors, suppliers)
  • Launching of the project construction
  • Monitoring of the project construction
  • Monitoring progress - keeping the client informed
  • Changes control
  • Assembly- installation on site
  • Start-up
  • Validation
  • Continuous cooperation and request of info about the customer satisfaction

Validation Documents

Users safety, product quality and data integrity are fundamental values for REMOIN.
Therefore, in the validation protocol supplied to the final customer, are included the Functional and Design Specification
of the machine, as well as all the necessary test sheets in order to perform the tests during FAT and SAT.
The validation documents issued by REMOIN consist of:

Standard documents:
Technical folder with:
- P&ID
- Layout
- Isometrics (piping & welding)
- Material certificates in contact with the product
- Boroscopies
- Welding specifications and procedures
- Welding reports
- Pneumatic P&ID
- Calculations
- Components list
- Instruments list
- Valves list
- Wiring diagrams and electrical list
- Instruments calibration certificates
- Operation manuals for components and instruments
- Hydraulic test reports
- Pickling and passivation reports
- PED certificates
- Operation manual
Documents provided upon request:
- Design Qualification protocol (DQ)
- Factory Acceptance Test protocol (FAT)
- Site Acceptance Test protocol (SAT)
- Installation Qualification protocol (IQ)
- Operation Qualification protocol (OQ)
- Performance Qualification Protocol (PQ)
- GAMP documentation

Factory acceptance test & Site acceptance test

In Order to verify the fuctionalities of our plants, we carry out the following activities:

Factory Acceptance Test
Test of the system at REMOIN premises: many tests are performed in REMOIN factory before delivering the plant to
customer. These tests aim to show that the equipment works adequately and that it can be installed and tested
onsite. The purpose is also to test the control panel of the plants, to carry out alarm tests and to check the plant
performances. During FAT a complete check of the documentantion provided together with the plant is performed
as well as the quality and the conformity of the whole plant and of each components.

Site Acceptance Test
Test of the equipment at the final user: these tests want to show that the system works in its own defined operative
location and that it interacts properly with other systems and devices. During SAT REMOIN technician inserts in the
control panel all the necessary set points for the proper fuctioning of the plant according to the characteristics of
customer’s site. He carries out all the tests alredy performed during FAT and he certifies the conformity

About Remoin

We realizes (ready for use) storage systems and distribution of distilled water, purified water, distribution circuits for clean steam, process piping, preparation rooms with automatic management of recipes (specifies for pharmaceutical and food industry), according to the recommended prescriptions by ISPE, FDA and cG.M.P..

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Via Tito Speri, 16 - 04012 CISTERNA (Latina) ITALY

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