MES Systems in Pharmaceutical Production – 5 Steps to a Successful Migration
So you’ve been using your MES (Manufacturing Execution System) for a good few years now – it’s hard to remember a time without it. The benefits have been realised and using MES has become an essential part of your manufacturing and operational processes. However as technology evolves and times change, maybe now is the time you are considering upgrading to the latest version, or indeed replacing your system as a whole.
So what needs to be considered, what decisions need to be made and how would you go about performing the migration?
In this article we will discuss MES migrations – how to make the right choice of whether to upgrade or replace, and how to go about executing the change to ensure a successful project is delivered.
Download our White Papers “MES Migration Part1 “Considerations for upgrading or replacing existing MES solutions & Part 2: Planning and executing MOM / MES migration projects” for further reading on this topic.
Replacement or upgrade – the choice is yours
Depending on your business requirements, you may choose to either upgrade your existing MES system to the latest version, or to replace it with a new platform completely. System upgrades involve activities related to moving an existing system to a higher version. The advantage of a system upgrade is its ability to retain the key configuration and setup of the existing system. However, there is a certain impact to operations when the upgrade is carried out and this should be factored in during the early planning phase of the project.
Replacing the MES system, on the other hand, means changing the system platform. This happens when the existing system is unable to meet the current and future business needs. Compared to a system upgrade, replacing the MES system has a bigger scope and will potentially require more implementation cost and resources. One possible advantage of replacing an MES system is that companies are able to continue their production operation with the existing MES system while the implementation of the new system is taking place.
Organisations that are currently use an MES system have already gained operational experience with their system, and have reached a level or maturity in regards to their MES-supported manufacturing operations. This insight is very useful, and the key learnings should be considered for deciding on the direction of the migration.
In most manufacturing organisations, MES has been closely integrated with other MOM (manufacturing operations management) systems, and such dependencies can create complexities for the migration project. Companies often face a host of issues in migrating MES, such as business disruption, project cost overrun and technology risks.
Time is another critical factor for any MES migration project, especially considering the cost and effort involved while maintaining software licences and resources for supporting two MES solutions – the current MES and the new MES.
Further Reading on this topic can be found in our “MES Migration White Paper Part 1: Considerations for upgrading or replacing existing MES solutions”
Understanding the MES architecture
MES enterprise architecture is very complex, so so its useful to understand the architecture in a little bit more detail. Changes to this architecture can have a huge impact on your manufacturing operations, potentially both in a positive or a negative way, so its important to understand exactly how the architecture works.
An MES migration project provides a unique opportunity for improvements in your business in many other areas, however, particularly in highly regulated environments such as Pharmaceutical, BioPharm and Medical Devices, understanding the risks and impacts of the changes must be a priority before any changes are carried out.
The architecture is composed of four separate domains – the IT Technology layer, the Data Architecture layer, the Application Architecture layerand the Business Architecture layer. MES migration can involve changes to some or all of the individual layers.
a. IT Technology migration
This involves changing the IT infrastructure or IT platform. It mainly includes changes in physical servers, network, database, storage and communication. Technology migration carries certain risks that should be considered carefully:
- Technical risks: – New technology often poses certain risks and challenges to system implementation and support. The risk becomes even more critical when it deals with a large number of GxP data that can eventually impact on final product quality and information. Identifying technical risks requires a clear understanding of what the changes are, as well as the boundary of the changes in the MOM context.
- Business risks: – As the MES plays a key role in manufacturing operations, planning for productivity loss and business disruption should be set as a high priority. This needs to be addressed in the deployment plan and the contingency plan in order to reduce the impacts to business when the migration faces challenges.
- Risk of cost overrun: – Many companies face the risk of cost overrun during an MES migration project. Certain hidden cost are not factored in or planned for at the initial stage of the project. These can include the cost of unforeseen downtime, additional manpower requirements, delay in purchasing IT hardware and insufficient planning for validation activities. Besides implementation costs, operating costs are considered to be of equal importance and should be monitored when justifying the return on investment
b. Data Architecture migration
Data migration can be initiated by a change of data storage, database platform or a change in business processes. In order to ensure a smooth data migration, strong expertise and understanding are required of what data need to be migrated, how the data migration can be executed and how to validate the migration to ensure data integrity.
c. Application Architecture migration
MES application architecture describes how the MES functions, as well as how it interacts with other MOM systems. Frequently, there is a lot of duplication in functionalities among these systems. Manufacturing lean activities and system consolidation have played an important role in driving MES application migration. Possible changes in application architecture are:
- Enhancing user interface
- Enhancing system functionalities
- Moving certain functionalities from MES to other systems and vice versa
d. Business Architecture migration
The key components of the MES business architecture are manufacturing processes and people. Most of the time, migration in enterprise business drives the changes in the application layer, data layer and technology layer. However, it is also recommended that the business processes are reviewed and assessed, in order to adapt them in conjunction with the change in technology. Enterprise business migration deals with changes in business processes and organisation.
- Business process improvement:
Business process improvement together with technology enhancement will help to ensure the robustness and the competitive advantage of the organisation. However, for complex systems like MES, too many changes on several layers will increase the risk to the project.
- Organisational improvement:
As the technology and business processes are changing, organisations must get ready for the change and need to be well equipped with new knowledge. This can be achieved through organisational improvement and knowledge management.
- Optimising organisation and resources: it is recommended that the current resource allocations are assessed when a new change is made to the business. The result of this assessment will then help to define if there is a need to optimise the workforce of the organisation.
- Acquiring new skillsets: IT staff and MES end users are the key stakeholders of any MES migration. It is important to identify the areas where expertise is lacking and ensure that training plans are put in place prior to the implementation phase and operation phase.
As MES migration can involve changes to some or all of the individual layers, it is important to understand and consider what, exactly you want to change.
The 5 Key Steps to MES migrations
With so much at stake, it is therefore imperative that the migration project is a success.
The following 5 steps will ensure that this is the case:
- Understanding the business driver for MES integration
- Assessing the impact of the change and identifying the Scope
- Evaluating the business case for the MES change
- Defining the migration strategy for the MES change
- Executing the migration
1st Step: Understanding the business drivers for MES integration
There are 5 main key business drivers that create a need for system migration. These should be considered in turn and explicitly stated in a Business Case, clearly justifying the need for the MES migration.
I. Reliability issues: – when the existing MES begins to show serious performance issues which severely impacts the manufacturing operation. These require fast action to address system performance issues. As a result, the scope of the migration will be more focused and the project timeline becomes a critical factor.
II. MES system obsolescence: – when MES vendors no longer support the old version of the system. The MES vendor usually provides early notice to companies of the plan to end support for the current MES. This window period is approximately 5 years before the obsolescence date. Companies are advised to incorporate this into the early planning for the roadmap of the MES as well as the MOM systems.
III. Technological factors: – as IT technology evolves, the company should keep up to date in order to remain competitive. IT technology is fast-moving and constantly changing to provide better value to business. New server or database versions are introduced every 2 to 3 years. However, too many changes in a GxP manufacturing environment imply a high level of risk. As a result, healthcare companies tend to stay with the existing MES systems for a minimum of 5 years. In most cases, unless servers or databases exhibit performance issues, a change of MES hardware is driven by corporate direction and planning. Technology migration should be planned as a part of MES and MOM system roadmap to ensure the all systems are able to integrate smoothly.
IV. Opportunity to improve: – the first implementation of an MES is never ideal for achieving an optimal system performance. As software solution providers, MES vendors are always looking for opportunities to make significant changes to improve the products. The business process is being reviewed and assessed regularly to identify the areas for improvement, especially in manufacturing environments. This will result in enhancements to the MES application. In addition, there are also improvements to the system which are carried out by MES vendors in order to stay competitive. Such a change should be performed in a timeframe of 1 or 2 years and it should not be so drastic as to create major impacts to production operations.
V. Strategic direction: – Corporate direction or IT strategy direction play an important part in deciding whether to upgrade or replace an MES system. Changes in IT strategy direction for MES may arise from the need to consolidate MES / MOM systems or reduce vendor dependencies. Irrespective of the nature of the change, early planning should be reflected in the MES roadmap to capture the overall picture of the migration.
Further Reading on this topic can be found in our “MES Migration White Paper Part 1: Considerations for upgrading or replacing existing MES solutions”
2nd Step: Assessing the impact of the change and Identifying the scope
MES migration is a complex process that requires a robust project management methodology. Depending on the urgency of the situation and the scale of the migration, the scope of the project needs to be reviewed and planned carefully. The right project scope will help companies to put sufficient resources in place and focus on solution design and migration execution. High level project scoping will serve as an input for the business case.
MES migration also requires rigid management of the dependencies that need to be considered when planning and executing the project. An assessment of the impact of the MES migration and the interdependencies as part of project planning is highly recommended.
- MOM architecture dependencies
- Vertical integration of MES with ERP and automation systems
- Horizontal integration of MES with systems like EQMS, DMS and others
- Integration of MES with manufacturing, quality and logistics processes and systems
The impact of the MES migration on those processes needs to be carefully assessed and managed, e.g. what will change regarding material transport; what are the opportunities to improve manufacturing processes; how will MES be integrated with quality management processes such as deviation control and CAPA; etc. As a result, MES migration may also have an impact on other systems and require software modifications and updating of SOPs.
- Training on the new MES solution
Training needs to be planned in close coordination with the production schedule to ensure that all users are properly trained on the system and on the newly designed or changed processes.
- Alignment with other projects and initiatives
As the MES system is highly integrated with other systems and MES migration projects are usually quite resource intensive, it is crucial to align a migration project with other initiatives and projects. This avoids bottlenecks due to resource availability constraints and ensures that technical dependencies are considered within the project portfolio.
3rd Step: Evaluating the business case
Once the business drivers and project scope are identified, the business case should be created. It should explain clearly the current challenges that the company is facing with the existing MES / MOM system, the overall description of the solution, a strong justification on why the migration is needed, the scope of the migration, the overall budget, and the return on investment.
4th Step: Defining the migration strategy
Once the business case is approved, the next step is to choose the migration strategy for the MES. This should be done by clearly understanding the objective of the migration, evaluating the impacts to the production shop floor and assessing the project’s triple constraints (timeline, scope and resources).
There are 3 options that companies can consider before making their choice
I. Big bang migration
A big bang migration is often chosen for projects that replace the legacy MES system with a new MES platform by a different vendor. It involves new technology, new application architecture and possibly a new way of working. The advantage of this strategy is that it provides a straightforward migration. There is no need for business users to operate the process with 2 different systems, hence it helps companies avoid potential mistakes. The challenges of using this strategy lie in the change management that needs to be planned in great detail. Issues may arise from user training, post go-live system support, or insufficient contingency planning.
I. Phased migration
A phased system migration divides the MES migration project into smaller sub-projects which aim to deliver incremental results. These projects still eventually help the company to meet the overall objective of the MES migration. Phased migration is less risky and allows employees to have more time to adapt to the changes. However, a longer implementation timeline is required to complete the entire project. A phased migration strategy is ideal for companies that are unable to afford the high productivity loss or where the MES is highly integrated
III. Parallel migration
Parallel migration is another strategy that aims to reduce the risk of MES migration. It has the same benefit as phased migration as it provides employees with more time to learn about the system. However, running both new and existing systems at the same time potentially requires business to maintain two sets of operations and support. Parallel migration can be the most expensive scenario for MES migration.
5th Step: Project execution – data migration
A. User requirements for MES migration
Once the understanding of the migration needs has been clearly addressed, it is recommended to draft the user requirements for the MES migration.
MES migration or changes can either happen on one or all of the enterprise layers (Business Archeticture; Application Architecture; Data Architecture; Technology architecture)
While developing user requirements, it is important to define the GMP criticality of each requirement. Early identification of critical and high GMP requirements helps to build quality into the system from the beginning and makes it possible to determine the right strategy for testing the system.
B. Migration and validation project phases
MES migration and validation projects differ from one another depending on the migration scope. Generally, MES projects in GMP environments follow the V-model validation approach and the project methodologies of the individual companies. The following table outlines the key highlights in the implementation and testing strategies for changes in each of the enterprise architecture layers.
C. Deployment and go-live
Changes to the existing system require a high level of detailed planning during the deployment and go-live phase. The success of an MES migration project is not only measured by the completion of the migration, but also by the minimised productivity loss to the production shop floor and how well the go-live stage is executed. To achieve this, companies should consider the following factors during the deployment and go-live phase:
- Review of the production schedule with a planner in a timely manner to identify the potential timeframe for deployment
- Integrate project activities into the planned downtime period
- Plan for the unexpected and have a rollback plan in place during go-live
- Plan for more supports post go-live
- Document and share the lessons learned
D. Data migration considerations
MES migration does not necessarily mean that all data from the legacy system can be migrated to the new system. The following scenarios for data migration need to be considered:
I. Migration of all data
Certainly the most desired scenario, however also the most unlikely one. If all data (master data, product data, batch data, equipment data, etc.) can be migrated to the new MES, validation of the data migration is required as part of the migration project.
II. Migration of some data
For most MES migration projects it is not possible to migrate all data to the new system due to enhanced database models and structures. An assessment is required on what data need to be migrated logically and what data can be migrated technically. If the new MES will be integrated into the same environment without changes to the equipment to be integrated, equipment related data most likely can be used for the new MES as well.
Assuming that the new MES provides enhanced (and improved) functionality, technical migration of master data, batch data or recipe data may not be possible or too complex to manage. A concept for migrating those data while using new and improved functionality must be implemented before actually starting the execution phase of the migration project.
III. No migration of data
In this context, no migration of data means no technical migration of data. Master data, product data, etc. must be re-entered manually into the new MES solution.
Whenever data cannot be migrated or migration of data is not appropriate, an archiving solution must be available. When archiving MES data, considerations regarding data retention and accessibility of data must be completed before archiving.
Whether upgrading or replacing an MES system, changes in the MES can happen on either one or more layers of the enterprise architecture (Business Architecture, Application Architecture, Data Architecture, or Technology architecture).
Regardless of what the changes are, an MES migration project is often very complex and faces a lot of challenges. A migration project offers even more challenges than an initial MES implementation. In order to achieve a successful migration, companies are advised to carefully consider the following factors:
- Have a clear understanding of the business drivers for the migration
- Evaluate and identify the scope of the migration
- Consider and include operational experience from the current MES
- Manage dependencies with other processes and systems
- Possess a strong knowledge of how the MES functions in term of enterprise architecture
- Identify the suitable migration strategy prior to detailed project planning
- Work closely with business users to create a detailed deployment plan
- Have a rollback plan in place during the go-live phase
How old is your MES? Do you think about an upgrade?
Our MES White Papers about MES Migration are available for download free of charge:
1. Claire Tran
Claire Tran is a senior consultant with HGP Asia with more than 10 years’ experience in managing and implementing information management systems for the pharmaceutical and medical device industry. Prior to joining HGP, Claire was the team lead and project manager of the Automation and MES team in Alcon Singapore. Her key strengths are in process improvement, project management, and computerised systems validation of laboratory and manufacturing IT systems.
2. Thomas Halfmann
Thomas Halfmann is co-founder and managing partner of HGP. HGP is a healthcare industry consulting company with regional headquarters in Switzerland, Germany and Singapore. Before founding HGP, Mr. Halfmann was Global Head Biopharmaceutical Operations IT and Head of the Global MES Program, both at Novartis. Mr. Halfmann 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 healthcare industry. He provides advisory and strategy consulting for the implementation of MOM (manufacturing operations management) and MES (manufacturing enterprise systems) solutions with more than 15 years’ experience in MES projects.
Since 2013, Mr. Halfmann is chairman and member of the advisory board of the MES & Process Minds, the annual international conference on MES in the pharmaceutical industry.
Lynne owen has recently partnered with HGP, bringing with her more than 15 years experience within the pharmaceutical and medical device industries. Having worked in a range of supply chain and project management positions, most recently on lean business improvement initiatives at both a local and global level, she is now excitied about working with organisations to share and develop expert knowledge areas via blogging and social media writing.