MES IN THE CLOUD
processes to upgrade software, notification processes, issue investigation and key performance metrics.
In a world where systems may all reside in the cloud, how do
these systems communicate with each other? Let’s assume that
the production capabilities are still physical and located in a facility. There are two main challenges associated with integration;
the integration of business systems with each other and the integration of MES with the equipment.
A current trend is towards using a cloud middleware solution to connect the various business systems (ERP, LIMS, CAPA,
Analytics). This enables connectivity between cloud applications,
but also between the cloud and systems deployed within production facilities. Some vendors have developed “connectors” that
make information available to other systems. The connection
between systems is reduced to drag and drop operations where
data objects from one system are mapped to data objects in
Separately, how do we connect a piece of hardware to MES
in the cloud? This can be done easily with the use of inexpensive
hardware components that make devices visible on the internet
by assigning a transmission control protocol (TCP)/ internet protocol (IP) address/port combination to the device. Interestingly
enough, if the MES application is designed properly, this approach has very little impact on performance.
To begin taking steps towards the deployment of a cloud-based
MES, organizations need to develop a good understanding of
their business requirements. As with any IT project, these requirements form the basis for the definition and configuration
Manufacturers must also prepare themselves to delegate con-
trol and responsibility while still maintaining accountability from
a regulatory perspective. This is definitely a significant change in
mindset, which in the short-term, creates the need for a strong
focus on establishing robust service level agreements. But if the
level of interest in cloud-based solutions is any indication, the in-
dustry appears to be ready to seek this next level of improvement.
And because some third-party vendors are also anxious to take
advantage of this new market opportunity, they too are changing
their perspective by developing compliant solutions.
Most in the industry would agree that specific guidelines in
the areas of auditing, validation and data integrity are now necessary to ensure that migration of MES to the cloud is most effective. This would no doubt fuel broad adoption by providing industry best practices on how processes should be deployed. That
being said, the benefits of the cloud are already very clear, and
manufacturers who have adopted cloud-based MES, mostly in
discrete industries, are gaining significant competitive advantage
through improved scalability, flexibility and responsiveness. MES
is increasingly moving away from being a facility floor system and
taking its rightful place alongside enterprise technologies.
Let’s keep in mind that the industry went through a similar
phase with the outsourcing of manufacturing operations to third
party organizations. Along the way, issues were identified and
resolved to support a vibrant industry, where some drug companies have become“virtual” organizations focusing mostly on drug
development and little on drug productions. This augurs well for
the future. CP
1. ISPE GAMP Cloud SIG Concept Papers (July 2016): SaaS in a Regulated Environment – The impact of multi-tenancy and subcontracting; Using SaaS
in a Regulated Environment – A Life Cycle Approach to Risk Management;
Evolution of the Cloud: A Risk- Based. Perspective on Leveraging PaaS
within a Regulated Life Science Company
2. ISPE GAMP Cloud SIG: Mike Rutherford (Lilly / USA) Kathy Gniecko
(Roche / Switzerland).
CHRISTIAN FORTUNEL is vice president at LZ Lifescience Inc. (USA). He
is responsible for operations management and the successful financial running of the U.S. business, as well as bringing a wealth of MES deployment
expertise to his role.