Pharmaceutical Company Turns to Robust and Secure Centralized Electronic Records System As Data Mining And Reporting Explodes In Their Manufacturing Processes


Manufacturing sector at a pharmaceutical company needed to greatly increase the amount of data being recorded during processing and packaging to enhance quality control, traceability and meet regulatory compliance. In addition, real-time records and alarming of the plant’s environmental conditions; room temperatures, pressures, humidity and differential pressures between areas; became a regulatory compliance requirement.


Design, configure, install and validate a robust and secure electronic data system for manufacturing that meets current and future requirements for process, packaging and building environmental data and reporting. Additionally, the vast increase in real-time data capture will necessitate that the plant’s manufacturing network be updated to ensure security, high availability and ample communication bandwidth for current and future data and information needs.


  • Interfacing with numerous disparate OEM systems for process, packaging and utilities along with the existing Johnson Controls Building Automation System (BAS) for data harvesting and reporting.
  • Connecting to disparate systems while meeting all network configuration requirements mandated by corporate IT for switch and firewall configuration and security.
  • Reverse Proxy configuration to provide access to trends and reports from the corporate network.
  • Meet budget and time constraints for the Capital Expenditure.
  • Specified, designed and configured a Stratus Fault Tolerant server system capable of being the centralized repository for all data and reporting.
  • Worked with corporate IT to configure switches and firewalls for proper access.
  • Specified and configured ACP ThinManger to provide thin client connectivity for Data Collection System and OEM systems.
  • Upgrade Data Collection System to Rockwell’s FactoryTalk View SE V10.0 and enhance display screens.
  • Reviewed and collaborated with OEM providers for configuration of thin clients, virtual images.
  • Install and configure new manufacturing Active Directory.
  • Document the new manufacturing network layout.
  • Add Rockwell’s FactoryTalk Historian SE for data archiving and trending.
  • Install and configure VantagePoint for viewing trends via web browser.
  • Configure SQL Server Reporting Services to provide batch, alarm, and audit trail reports over a web browser interface, for data taken from OEM systems.
  • Tie into Johnson Controls Building Automation (BAS) system to view and historize room temperatures, pressures, humidity’s.
  • View Johnson Controls BAS audit trail reports over web browser interface.
  • Configure Reverse Proxy server in the DMZ to provide access to reports and trends on the corporate network.
  • Configure WIN-911 for remote alarm notification.
  • Configure VEEAM Backup and Restore to backup VM images to an off-site NAS drive.
  • Data Collection System was fully validated to ensure Data Integrity and to meet Title 21 CFR Part 11 regulatory compliance for electronic records.


The Data Collection system installed at the pharmaceutical manufacturing facility met all project objectives and provides a fault-tolerant solution for archiving, viewing and reporting of data across multiple OEM vendors and utility skids as well as their BAS while ensuring data integrity and security. Now production, QA, engineering, management and maintenance have a single source for viewing critical data, reports, trends and building climate environmental information in both real-time and historical.

The client is having Malisko replicate this system at their other manufacturing facilities.


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