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VALIDATION AND DOCUMENTATION

We understand Documentation is as important as the equipments, helping the users qualify and validate their systems. Specific attention is called for documenting necessary procedures, tests & certifications, providing systemic proof of compliance while building the system.

We provide all documentation support to enable the users complete their validation dossiers. The entire documentation package consists of:

  • Design Qualification (DQ) – a documented review of system design for conformance to operational and regulatory expectations
  • Installation Qualification (IQ) – part of final qualification activity, it relates to the detailed design of a system and verifies the installation of equipment and instruments
  • Operational Qualification (OQ) – ensure that individual components, instruments, controls and the system as whole operate on-site as designed

These documents include:

  • Drawings pre-construction & as built
  • Piping drawings
  • Weld Maps
  • Inspection reports
  • Calibration reports
  • Manufacturer’s certificates
  • Owner’s Instruction Manuals
  • Operators Bill of Materials – Mechanical and Electrical

Factory and Site Acceptance Testing

Factory Acceptance Testing of systems at our dedicated testing facility, assist users to get acclimatized to the system before it reaches site also providing close to real conditions while testing.

Factory Acceptance Testing (FAT) includes:

  • Dry FAT
  • Mechanical Acceptance Test (MAT)
  • Electrical Acceptance Test (EAT)
  • Functional Evaluation Test (FET)
  • Production Data Report (PDR)

Various Utilities may be required while conducting FAT. Some of these can be met with our present infrastructure. Specific project testing demands are analyzed together with our clients prior to signing a contract.

Shashvath Fabricators And Engineers Pvt Ltd, founded in 2014 in Thane, Maharashtra, is a trusted manufacturer and exporter of pharmaceutical formulation machinery, delivering reliable and efficient solutions for pharma, cosmetic, food, and chemical industries.

Address

Shashvath Fabricators & Engineers Pvt Ltd
Riddhi Siddhi Industrial Estate Building No 1 Golani Naka, Vasai -E, Maharashtra 401208 India

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