RYAN BERTRAM


“Nothing in this world can take the place of persistence. Talent will not: nothing is more common than unsuccessful men with talent. Genius will not; unrewarded genius is almost a proverb. Education will not: the world is full of educated derelicts. Persistence and determination alone are omnipotent." -Calvin Coolidge

After a 12 year-old Ryan visited the Corvette factory in Bowling Green, Kentucky, he knew he wanted to part of how America makes things. With continued interest in the art and science of manufacturing, Ryan pursued his Bachelors in International Business at Calvin College. After graduating, he realized his dream of working with manufacturing by holding client relations positions throughout the manufacturing industry. At Malisko, Ryan enjoys bringing together the right people for the right job to tackle complex projects, and helping to bring the total solution to the client's plant floor.

Personal Passion
He likes spending time with his family and helping his children to blaze their own trail.

Dream Job
Build houses for Habitat for Humanity

Interesting Fact
He secretly likes the handy-man "fix-it" list his wife gives him every weekend. (Shhh! don't tell her that though!)

CARRIE LEINICKE


"Do not worry about your difficulties in mathematics; I can assure you that mine are still greater" - Albert Einstein

Numbers have always come easy for Carrie. With her natural ability and interest in numbers, Carrie achieved her Master of Science in Accounting from Fontbonne University and then her Master of Business Administration from Webster University. Joining the Malisko Team in 2019, Carrie is very customer service focused and being committed to finding answers for clients. She's passionate about providing accurate financials and forecasting to support high-level business decisions and strategy.

Personal Passion
Being outdoors as often as her schedule allows.

Hobbies
Camping/Traveling with her Siberian Husky, Sailing at Carlyle Lake, and antiquing mid-century/art-deco items.

DAN HARDER




TBD

Personal Passion
TBD

Hobbies
TBD

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

Objective

  • 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

     

SOLUTIONS

 

  • 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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