SmartSCS for FDA 21 CFR Part 11

SmartSCS for FDA 21 CFR Part 11

Introduction

Smart SCS is a simple user interface for a wide variety of measuring instruments and technologies: optical measuring machines, CMMs, CT systems, laser scanners and fringe projection systems, as well as contour, roughness and wave measuring instruments.


A key advantage is that there is a single, uniform, powerful, and highly customizable software interface, allowing ALL measuring devices in a company to be started with ONE software program. This means that, in particular, operator self-inspections can be carried out in single-shift or multi-shift operations, even without specialized metrological knowledge.

     

How is this different than Shop Floor Launcher?

Shop Floor Launcher is an included component to CMM-Manager, where SmartSCS is developed by a third-party and designed to operate with systems beyond those compatible only with CMM-Manager.  The capabilities of Smart SCS go beyond that of a simplified user interface meant to easily launch pre-programmed inspection routines and adds functionality specific to FDA 21 CFR Part 11 compliance.



Here are some key features of SmartSCS:

  1. SmartSCS is designed for operator self-inspection, GAMP / FDA- compliant measurements, and links measurement sequences with text instructions, images, or videos.
  2. Simple — Start the measurement with a click, e.g., on the image of the component.
  3. User-specific — User-assigned measurement sequences for parts and pallets
  4. Quick — partial setup and measurement results
  5. Secure — Password protection for measurement processes
  6. SmartSCS is compatible with multisensor measuring devices, CMMs, computed tomographs, lasers and fringe projection from common manufacturers.
  7. Visual feedback for each process step
    1. SmartSCS organizes measurement sequences so that they can be easily selected and executed by any operator. Simply select the text or image icon to execute the assigned measurement sequence.
    2. SmartSCS allows users to select measurement sequences that are relevant to them. Only the measurement sequences that the user needs to work with are displayed.
    3. SmartSCS displays the results on the screen immediately after a measurement sequence is completed, enabling immediate corrective action. The results can be printed, saved, discarded, or transferred to other applications (e.g., statistical analysis).
    4. SmartSCS optionally offers comprehensive support for handling robots, pallets and mechanical feeders, which can be provided by OGP itself, the customer or third parties.
  8. PDF Report output including electronic signature
  9. User Management with Password (GAMP/FDA-Conform)
    1. Password expiration date
    2. Password history
  10. Audit Trail (GAMP/FDA-Conform)
    1. Comments for features
    2. Report with PDF (including Header information’s with GAMP/FDA comments)
    3. Approver application with FDA comments
    4.  Reviewing from not approved measure results
    5.  Approving from measure results with comments

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