Case Study

Case Study

Historian Upgrade Enables Process Optimization and Assures Regulatory Compliance for Pharmaceutical Manufacturer

A historian collecting pharmaceutical process data to meet regulatory compliance is valuable only if the stored data is consistent, reliable, and secure. One of our clients was faced with a very unstable, unreliable and unsupportable historian that was jeopardizing its manufacturing operation. In this case, a pharmaceutical manufacturer’s existing historian system was crashing, losing data, causing unplanned downtime and could not produce reliable data reports supporting regulatory compliance. Malisko was tasked with helping our client meet its expectations for a robust data historian.

BACKGROUND

  • Previous integrator was not successful in migration
  • Broke more than fixed, which is why the client called on Malisko to fix the issue
  • We came in with confidence and a good plan based on plenty of experience grounded in a structured and well documented approach following best practices and computer system validation (CSV) for data integrity and security

OBJECTIVES

  • Migrate to a new version of Historian
  • Install redundant data interface servers
  • Bring all previously collected data back into view
  • Performed FDA-compliant CSVe to ensure redundancy, data integrity, security and audit trail
  • Ensure a robust and well-documented historian system meeting regulatory compliance for future scalability and reliability

CHALLENGE

  • Extremely aggressive schedule – “get it up and running NOW”.
  • Short downtime window
  • Migrating old system to format the new
  • Little to no documentation on existing system
  • Managing years-worth of data
Multi-step approach to ensure accuracy, maintenance of existing stored data and minimize downtime

APPROACH

Multi-step

  • New servers were built and tested in our office
  • Initial wave of Data Migration done in-office after a trip on site to gather the first round of existing historian data
  • Final wave of Data Migration performed on-site
  • Created VSV documents for new servers and a Data Migration document to validate existing data was migrated correctly
  • Minimal downtime achieved, less than two day

RESULTS

  • Fully redundant historian – Used for reporting and releasing batches meeting regulatory compliance
  • Laid framework for future upgrades and streamlined processes
  • The client relies on our upgrades for batches to be accurate and consistent
  • Data flow and reporting is streamlined
  • Continued trusted relationship with client that we still work with today
LEARN MORE

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