Traditionally, MES implementations, including MBR (Master Batch Record) and MES modelling , have been executed by project teams located on site owing to the complex nature of the projects. However, as MES becomes better understood by project stakeholders, there are opportunities to consider other options.
Once a decision has been reached to implement MES, the fundamental question to address is if you want to develop these resources from your existing team, hire in new resources with specialist skills or use a third party integration company to support this need?
Generally the best model, which produces the greatest long term benefits to operations, is developed by a combination of business resources and specialist modellers.
Typically, MES implementations have been executed by project teams located on-site
The main factors influencing the decision to perform work on site are:
• MES projects impact many if not all site functions
• MES projects are usually complex
• Definitions, interpretations or expectations of MES systems remain many and varied
• MES vendors and integrators are typically still learning what best practices are applicable to various plant types. This requires a high level of interaction with the client
• There may be reluctance on the part of the client to relinquish control, based on the cost and complexity of the project
Global Shortage of MES Resources
However, there are some challenges that sites face when using this model:
- There is a global shortage of experience MES resources
- Sites resourced for sustaining workload
- Scope creep and moving deadlines
- Upgrades generally require additional skill-sets, possibly beyond the capability of the MBR editors
- Trend towards process and documentation harmonization
Recognizing the costs associated with the delivery of MES, the ongoing scarcity of strong MES resources and the challenges with retaining this type of person, ESP have been successfully developing a model to deliver MBRs more efficiently with improved quality/consistency through a blend of on-site and off-site work for various stages of a project.
MBR Factory is a methodology where the majority of MBR modelling to carried out by a team sitting off-site. The key drivers behind this are:
- Decrease cost while increasing quality: MES projects have become complex and costly. If executed correctly, the MBR Factory model offers control and opportunity to simplify and standardize, reducing cost and improving quality of outputs.
- Find highly qualified resources: Utilize highly specialist MES resources with minimum travel & living time and expense burdens. Conventional site work does not always attract the best resources.
- Life cycle support that is affordable: Establish a core team to support the MES system life cycle instead of providing supplemental resources who are gone once the project is over.
- Deliver on time & within budget: Fixing scope under the MBR Factory model enables these essential requirements to be met.
Site work is still required in this model and mainly involves requirements and design workshops and final on site system testing – with all the system modelling, documentation and functional testing taking place off site. Typically, on previous projects executed using this model, the offsite-onsite split is 80:20.
…More and more companies are using specialist resource teams based off-site
While the traditional model of using site based resources is still the most prevalent approach still used in the life science industry, more and more companies are using specialist resource teams based off-site to achieve improved quality and standardization of MBRs while reducing the cost of delivery. There are challenges to overcome, not least individual sites giving up direct control of their project. These can all be overcome with MBR Factory, using trusted specialist resources, fixing scope and applying appropriately tight project controls.
ESP will speak on this in more depth at Pharmatalk 2015, taking place in Berlin, Germany, May 11-12, 2015. Visit the Pharmatalk website to find out more.
Alternatively, if you would like to speak to ESP directly about how ESP can offer support for your MES implementation, contact us in Ireland or USA.
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