5 good reasons to upgrade or replace your Pharma MES!

HGP ServicesMES emergency call – How the topic came up

A couple of years ago I received an emergency call from one of our clients: “Hey Thomas, I just got a message from IT who told me that they will no longer support our current IT infrastructure for MES! As it’s the last application that is using the hardware, operating system and database, IT have decided to abandon the support from the 1st of January. The vendor of the infrastructure stopped supporting us a few years ago. I there any chance you can help me migrate our current MES application onto the new infrastructure?” “Of course I can help you with that,” I replied “but are you certain that it is technically possible to migrate your MES to the new IT infrastructure?”

As you can imagine, maybe from your own experience, this was the starting point for much longer discussions, resulting in some serious activities in the subsequent weeks. We started by assessing the technical feasibility of migrating to the new infrastructure and found out that we had three options: Either we do some serious modifications of the current MES application (with all the consequences described further below in this article) we replace it with a new version of the current MES or we replace with an entirely new MES system altogether.

After considering the three scenarios (via assessing the technical feasibility, costs, risks and opportunities) the client decided to stay with his existing MES system, and only migrate his data to the latest version. Although this decision was taken primarily after assessing the project risks (as the MES database could not be migrated from the client’s older platform to the vendor’s current platform), and at the time seemed the best solution, it is however worth noting that the actual costs and effort accrued were comparable to those that would have occurred if an entirely new MES system had been installed instead.

MES applications have a long shelf life, both as a product and as an operative installation, however as this case shows there comes a point in time when a company must make a decision on when and how they will replace their current system. In the aftermath of this project we discussed this with many other companies and found that whilst there is awareness of this fact, many companies are firstly not prepared to make the decision to replace their systems, and secondly do not have a process in place for MES migration to take place. What the project above also demonstrated, as all of us involved in MES operations already know, that whilst the impact of MES migration on IT personnel and processes is very high, on manufacturing operations it is simply enormous.

Manufacturing Execution Systems have been around in one form or another since the early 1980s. Many healthcare industry companies implemented a variety of different MES solutions during the 1990s and 2000s, which are now or near at the end of their lifecycles. In the meantime, MES providers have migrated their solutions either to new technology platforms or developed entirely new MES solutions. In parallel functionality of MES solutions has increased since the 1990s to cover all manufacturing processes from API production through secondary manufacturing to packaging, including material management, equipment management, and electronic batch recording.

Is your MES installation of an older generation? Then you should ask yourself the following questions:

  • Does the existing MES need to be upgraded or replaced?
  • When is the right time for an upgrade or replacement?
  • What is the best option for you – upgrade or replace?
  • How should the upgrade or replacement be executed?

How would you make your decision?

5 good reasons to upgrade or replace the current MES

Several factors can lead to the decision: YES, we will do something about our current MES.

Basically, there are 5 relevant business drivers:

1.   Reliability issues: Is data integrity ensured?

The most urgent reason that a company may need to upgrade or replace their MES is if the existing system is displaying problems with reliability. E.g. performance problems, response times, frequent system re-boots etc.

A more serious symptom of system reliability problems, particularly in regulated industries, is the risk of data corruption or loss. Data integrity cannot be ensured anymore. With this kind of problem, there is obviously a compliance issue which can lead to scrapping of product, resulting in a serious inspection finding or in the worst case putting patient safety at risk.

Last year a pharmaceutical company experienced a serious data integrity issue after implementing a standard upgrade. The MES was initially implemented 10 years ago, and had undergone lots of customization and several upgrades. The MES version was no longer supported by the MES vendor, however the company decided to continue with the installed version and to not migrate to the latest platform. A few months after installation of the upgrade, several examples of missing data were identified in the database, including data that was critical for batch release – as such the recall of several batches was considered.

It cannot be proven that this would have been avoided by migrating to the latest platform of MES, however it is worth considering a few areas:

  • the current MES platform was no longer supported as a standard product by the vendor
  • The highest priority for the developmental capacity was assigned by the vendor to the new platform
  • Further development of the “old” MES was very much down the priority list

2.   Missing support for older versions

Do you remember that your last Smart Phone was only a few years old and technically absolutely OK? Nevertheless, you decided to replace it with a newer version, so that you could keep using it with updated software and obtain full performance. The same situation happens with your MES: As MES vendors develop new versions of their solutions using the latest technology, they become less interested in putting resources into support or further development of older versions. This results in either no support for the obsolete version, or limited support at an increased cost.

3.   Technological issues with other systems

Technology issues are not only related to the MES platform itself, but also to other systems which are used in the manufacturing operations environment.

The most obvious things which will directly affect the MES are the database and operating system versions. The database and operating system vendors, too, will eventually make their older products obsolete. This means that there will come a time when the latest version will not be compatible with the existing MES. If the MES is not upgraded or replaced, the company has to either continue on an unsupported platform, or to customize the MES to run on a supported version – which is not always possible.

So, when deciding the need for an upgrade, a big consideration is the overall manufacturing IT landscape that the MES is operating in!

We have seen several MES upgrades or migrations that were driven by larger upgrades of other systems that have interfaces with MES. Before upgrading the interface of the MES due to an upgrade of ERP for example, it should be evaluated if the latest MES platform by the vendor might provide the interface technology required.

More details on which systems are relevant in Healthcare and should be considered in this context can be found in our HGP White Paper.

4.   A great opportunity to improve!

Not only the risks involved in maintaining an existing MES in a changing environment can be a driver. You could also see it as an opportunity to take advantage of technological breakthroughs – and thus obtain even greater business benefits for your manufacturing organisation.

Over the years, MES vendors have constantly made improvements to their products. And these are likely to deliver real business benefits which would otherwise be too costly, or even impossible to achieve:

  • New functionality based on experience with customer’s processes
  • Simpler and standardised interface design
  • Greater data handling capability
  • Improved user interfaces
  • Use of mobile technology
  • Improved capability for communication with automation and historian systems
  • Reduced infrastructure costs
  • Easier parameterization and customization (depending on strategy)
  • Less dependency on customization (depending on strategy)

When a client of ours migrated from a previous MES platform to a new platform, it was not just a technological upgrade that provided a lot of IT related benefits, such as decrease in IT maintenance costs due to higher degree of standardization and using up-to-date technology. An important part of the project was to evaluate, together with the MES solution provider, how manufacturing processes can be improved and how the new MES could contribute to this improvement. In several workshops and on-site sessions, a team consisting of process experts and technology experts assessed all possibilities following a structured method. At the end of the day it was not just MES that was upgraded to the latest technology, but also strategically important KPIs, such as throughput-time and OEE were significantly improved by applying the new technology. This would have not been possible by continuing with the existing solution or by just migrating processes as-is to the new platform.

By our client embracing the need to change the IT tool, the more important task of improving the core manufacturing and support processes was also realized – and this is something that really should not be overlooked in your “MES – replace or upgrade” decision making exercise.

For more details regarding the strategic influence, please refer to our detailed White Paper MES Migration Part 1 (“Considerations for upgrading or replacing existing MES solutions in healthcare companies”).

5.   What is your strategic direction?

Imagine your organization is acquiring new companies including several manufacturing sites coming into your network. In most companies systems like ERP, MES, EQMS, LIMS and others are standardized across all sites of the manufacturing network. If your newly acquired manufacturing sites are already using MES, but not the same system as you, each site must undergo an MES migration project. If your organization is facing such a challenge, it might be worth developing a standard method and approach for those migration projects. Standardization does not just mean having the same solution or vendor for a class of a system – standardization as a strategy covers all aspects, such as systems, system integration, IT infrastructure, organization, and harmonization of manufacturing processes across sites.

Sometimes the need to upgrade or replace an MES can come from a strategic decision made at corporate level. It is common for companies to have objectives aimed around reducing the number of IT vendors, reducing the number of applications on the shop floor, or providing a harmonized IT architecture across multiple sites. In these cases, the focus should be more on the solution to be chosen rather than whether an upgrade or replacement needs to be made.

Using the recommendation given by ISA-95, might be a good starting point to determine the strategic direction of the future manufacturing operations environment – for example using the ISA-95 activity models and data models.

This blog will be continued! The next blog article will describe when is the right moment for a change, whether upgrade or replacement is the right solution and 4 things you should take into consideration when you take your decision.

HGP_White Paper MES Migration Part 1: Considerations for upgrading or replacing existing MES solutions

For more details, pls. refer to our White Paper MES Migration Part 1 “Considerations for upgrading or replacing existing MES solutions in healthcare companies” where a diagram describes the 5 categories and shows a high level process flow of the steps needed to assess the business drivers.

The Authors:

Tim Owen: healthcare industry professional with over 30 years experience, specialising in the implementation of paperless manufacturing and manufacturing execution systems, business process analysis and process modeling. He was member of the Global Center of Excellence for MES at Novartis Pharma where, as Business Analyst he supported the implementation of MES at various production facilities. For the last four years Mr. Owen provided consultancy services for MES implementations and, most recently, enterprise level Serialization initiatives. Sadly, he passed away before his time in January 2016.

Thomas Halfmann: co-founder and managing partner of HGP.  Before founding HGP, Mr. Halfmann was Global Head Biopharmaceutical Operations IT and Head of the Global MES Program, both at Novartis. He is an expert in paperless manufacturing, track & trace, business process analysis and modeling, project management, quality management, and computer system validation with more than 20 years experience in the pharmaceutical and healthcare industry.

Mr. Halfmann provides advisory and strategy consulting for implementation of MOM (manufacturing operations management) and MES (manufacturing enterprise systems) solutions with more than 15 years experience specializing in the MES arena.

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