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  • Sieo-

  • Development of BMS System for Critical Systems Start Date: January 01, 2014
    Completion Date: March 15, 2014

    Project: A manufacturer of pharmaceutical solutions for human consumption significantly increased the use of SCADA systems for monitoring and control of the following systems: Environmental conditions of production and packaging areas, Critical Services Systems, General Services Systems, Pure Steam Supply, and HVAC.
    Quality, validation, and maintenance users are required to constantly obtain reports and trends from the server, and the information needs to be stored on two different servers for security reasons.

  • Project Objective: Develop a Building Management System (BMS) based on the Simatic Win CC platform for monitoring, information storage, and report generation that complies with the requirements of Electronic Signatures and User Management EU CFR-21 part 11. The system must also have complete technical documentation and Quality Assurance protocols FAT and SAT, and system qualification DQ, IQ, OQ.

  • Sieo

  • Overview

    • Simatic WIN CC Server 7.2

    • Simatic Logon

    • Simatic Process Historian

    • Simatic Information Server

  • Results for the Client

    Operators, quality personnel, validation, and maintenance staff are more than satisfied with the results.

    "Reports are generated with a lot of detail and obtained much more quickly."

    It is easier to find data without having to jump from application to application.

    "Now the systems are monitored with greater reliability"

  • Compliance with Regulations and Standards

    The project was designed and developed to comply with the following regulations:

    EU CFR-21 (Code of Federal Regulations), Parts 210 and 211 (Good Manufacturing Practices, April 2007), Part 11 (Electronic Signatures and Records, August 2001), and Part 820 (Software Validation and Automated Equipment, April 2007).

    GAMP4 Guide for Validation of Automated Systems, December 2001, Published by ISPE.

    General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002.