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OT/ IT Health-Check Executive Summary

Problem Statement 

Numerous investments have been made in Manufacturing OT/IT (Operations Technologies/Information Technologies), for Automation, MES, LIMS, WHMS in the Pharma, Biotech and Med Device industries in the last 30 years. One example is the significant ramp-up of investments in the last 15 years with the advent of successful MES projects in the life sciences. There were numerous unsuccessful attempts in the late 90’s and early 2000’s to implement MES type systems. 

Promises were made of return on investment, improved compliance, efficiencies, effectiveness, improved OAE to name a few. Globalization, changing regulations, mergers and acquisitions have changed the landscape and rendered some of the claimed benefits ineffective and unachievable. 

How have these Investments Paid-Off? How can you tell? 

Now companies are asking if they need to continue investing, change to new paradigms, stop investing altogether and go back to the way they were. They’re asking because these technologies are starting to be dated and need upgrades, enhancements, the infrastructure is vulnerable to intrusion and is becoming unreliable. 

Were re-capitalization plans put in place when the original projects were approved? Typically, not. 

This is a business issue not a technology issue. IT and Engineering cannot determine for the business whether further investments are required or what the next steps are. 

GOTIT-QS has significant experience in facilitating such assessments. We can support management in coming to the right conclusion on identifying next steps to ensure long-term success of your business re-engineering and technology investments. 

We can assist your organization by facilitating assessments of your systems, analyzing the output, and identifying next steps to optimize and ensure long-term success of your business re-engineering and technology investments.

Solution  

GOTIT-QS offers a process to help companies quantify what has been realized in the areas of: 

  • Return on investment
  • Compliance
  • Efficiency
  • Effectiveness
  • Operational Asset Effectiveness (OAE)
  • Automation (O/T, I/T)
  • Systems Integration
  • Manufacturing IT (MIT) and Automation Systems Lifecycle
  • Project Planning
  • Long Term Re-Capitalization 

Process Overview 

Through the experience and knowledge of GOTIT-QS, the OT/IT Healthcheck can help establishments evaluate the health of their technology investments and determine the right course of action based on their vision for the future, what the company expects to look like in five to ten years? It also means looking at what re-engineering is required and whether any technologies need to be deployed to support the vision. 

The deployment of the solution typically involves the following steps: 

  • Questionnaire
    • Provides structure and direction to the process and evokes discussions.
  • Workshops
    • Clarify the questionnaire responses and identify areas of concern for the business
  • Interviews
    • Both business and technology need to start verbalizing their concerns as highlighted in the workshops
  • Preliminary Assessment Report
    • What is the current situation based on analysis derived from questionnaire responses, workshops and interviews?
  • Future Vision
    • The business needs to put together their future vision for the site such as:
      • Expected volumes
      • Complexity
      • Product mix
      • Financials
  • Gap Analysis Workshops (GAW)
    • Identify the delta between the results in the preliminary assessment and the future vision
    • Identify the tasks, processes and technologies that will cover the gaps
  • Post GAW Project Plan
    • Based on the future vision and the GAW results, what are the activities required to close the gaps and in what sequence.
  • Benefits plan
    • What are the benefits both tangible and intangible of implementing the project plan?
      • Quality
      • Compliance
      • Efficiency
      • Effectiveness
      • Reduced costs
      • Reduced waste
  • Financial Plan
    • What is the financial impact of the project plan both in terms of cost and benefits?
  • Monitoring
    • The business must actively monitor the implementation plan to ensure the benefits are realized, the project plan is implemented on quality, on time, on budget.
    • Subsequent abbreviated yearly OT/IT Healthcheckã is recommended to ensure agreed plan is on track


Data Integrity Compliance

Through FDASIA Title IV Section 706 the FDA will be allowed to request and obtain records – electronically or in physical form – in advance or in lieu of an inspection. The OT/IT infrastructure will play a large role in determining what data to provide, and identification of quality metrics to monitor and track as indicators of control over the process and adherence to quality standards. (Reference: FDA Request for Quality Metrics - Guidance for Industry Draft July 2015)
Regulatory agencies are now working more actively with organizations that are "embracing" technology a little more and looking for pharma to be more innovative.  For example, the FDA will collect data (quality metrics) from the regulated establishments and draw conclusions from that data. 

For good, reason data integrity is a very hot button for the regulatory agencies. Our extensive experience in ensuring your processes and systems support and enhance your data integrity capabilities will help you meet the data integrity compliance and quality requirements.


Global OT/IT Quality Services can be an active partner in supporting you in that process. We can facilitate the determination of the data needs to be kept and provided to authorities. Global OT/IT Quality Services can help you reduce variation in your processes and maintain control over them.