Fette offers a comprehensive portfolio of documentation options including testing protocols, validation packages, drawing packages, material certificates, etc. These choices are available either with a new machine purchase, for upgrades, or as add-ons at a later date. Some of the documents we offer include:

Additional printed operating manual

Need additional hard copies of your machine operating manuals for a new or older press? Please contact our Spare Parts Department with the machine type and serial number and we will get back to you quickly.

Standard validation package

This document covers the most common IQ/OQs for the tablet press

Advanced validation package

This package has the most common IQs and extended OQs for the tablet press. Certain features and tests can be modified with this package. Please contact our Documentation Department for details.

Standard Function Specification (FS) for the tablet press

This document describes the system with respect to its functionality and technical specifications. The aim of this functional specification is to define the basic functions of the Fette system based on the customer’s user requirements

Standard Computer System Validation (CSV) for the tablet press

This document includes a Software Design Specification and Hardware Design Specification.

Cleaning Validation for the tablet press

Provides the product contact part drawings and dimensions with calculations for determining surface areas for cleaning.

Material certificates for the tablet press

Provides copies of the original certificates for the materials of construction for product contact parts on the Fette tablet press.

Traceability Matrix (RTM) for the tablet press

This document links the System Design Specification to actual installed software modules and mechanical components. It also correlates the software modules and mechanical components to the FAT, IQ, and OQ protocols so as to provide linear traceability throughout the design, construction, and testing of the system. The traceability matrix can also show how these components relate to the installation,
operation, and maintenance procedures for the equipment.

Customer specific room layout

Our in-house, Special Projects Engineer, can take your room dimensions and create an optimized lay-out for your tablet press and ancillary equipment.

Standard SAT-Protocol for the tablet press

This document covers the most frequently used features of the press to ensure the machine’s functionality for testing at your site.

Preventative Maintenance Manual

Contains procedures and illustrations cover the maintenance of the equipment.

System Design Specification

This document describes details for customer requirements and the mechanical features for the press. Included are detailed descriptions of mechanical sequencing and functionality, as well as additional descriptions for inputs, outputs, configuration, and automated sequencing. This document references wiring diagrams and mechanical drawings.