NEXUS – Customize SCADA Solution 21 CFR

Nexus Provides Total solution for Supervisory Control and Data Acquisition (SCADA) System combines software and hardware to create a control system that is frequently referred to as automation technology.
The system receives data about processes and related equipment, which supervisors then use to control and optimizes operations.

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Description

Supervisory Control and Data Acquisition (SCADA) System combines software and hardware to create a control system that is frequently referred to as automation technology.
The system receives data about processes and related equipment, which supervisors then use to control and optimizes operations.

SCADA systems are tremendous assets in the pharmaceutical, medical device, and other FDA regulated manufacturing industries, providing cost efficiencies, and improving the consistency of product quality. This enabled the industries to move from hardcopy to electronic production records.
Production related electronic records are subject to compliance with the same predicate rules that would apply under paper-based quality systems.
the systems that produce and retain these records are required to comply with 21 CFR Part 11 rules for electronic records and signatures.
SCADA system records and functions that are subject to 21 CFR Part 11:

  • User access security restriction
  • Electronic signatures
  • Graphical https://nexusautomech.com/wp-content/uploads/2022/01/IPPC-3-1.png interface (GUI) displays, operator entries, and controls
  • Recipe creation, editing, and version control
  • Recipe sequence enforcement
  • Electronic logging of recipe procedures executed by system with time-stamped audit trails
  • Data collection, storage, protection, audit trails, and retrieval.
  • Production data historian with audit trails and reports
  • SOP’s for life-cycle management

Production data is acquired primarily from manufacturing equipment instrumentation via process logic controllers, as well as operator workstations and interfaced peripherals.
Production data is also generated in the form of batch identification and target parameters from the recipe and batch databases. Interfacing manufacturing execution systems (MES), and enterprise resource planning systems (ERP) may also provide data for the batch record.
All critical data collection functions must be qualified to ensure the integrity of the data acquired by the SCADA software system and stored in the resulting electronic batch records.

Application

  • manufacturing industry
  • pharmaceuticals
  • medical devices
  • Petrochemical industry
  • Drinking water delivery system
  • Water waste collection systems