Pharmaceutical industry MES GxP
We help pharmaceutical sites and GMP-regulated industries define, implement and support their MES. Our specialty is Siemens Opcenter Execution Pharma.
Let’s discuss your MES project
Recipe design
An MES recipe is your process translated into steps: the materials to check, the data to enter or retrieve, the checks to perform and what allows the next step to start. Well designed, it guides the operator and fills in the batch record at the same time.
On a project delivered by our consultants, two recipes cover more than 220 items. A new item is added without changing the recipes.
Read the case studyMES interfaces
The electronic batch record does not fill itself. The production order comes from the ERP. Test results come from the LIMS. Process parameters come from the SCADA or directly from the equipment. The MES collects this data, checks it where needed, and links it to the right operation. It can also send data to other systems, such as a historian. In the end, the batch record contains everything, with its evidence.
On a project delivered by our consultants, the MES exchanged data with SAP, the SCADA, the balances and the local instruments of a vaccine building: pH meters, filter testers, osmometers.
Read the case studyBatch record review
With review by exception, everything stays in the batch record, passed results and deviations alike. But the MES flags the deviations, under rules agreed with production and quality. Your reviewers no longer read the passed lines one by one. They spend their time on the real issues, the ones that need analysis.
On a project delivered by our consultants, review of media preparation records went from three weeks to half a day.
Read the case studyOur consultants’ experience
What we offer
You can entrust us with a complete scope, including its deliverables. You can also bring one of our consultants into your team, or your integrator’s team, for a specific skill or phase. Either way, we agree on roles before we start.
We start from your production operations to define what the MES must cover, the target architecture and the exchanges with your other systems. On a new site as on an existing one.
Business requirements · Functional architecture · Review strategy
Case study
Two recipes cover more than 220 items. A new item is added without changing the recipes.
We design the recipes, build the exchanges between systems and prepare the tests with your production, quality and IT teams.
Master Batch Records · Interfaces · Testing and qualification
Case study
A building moved from paper to MES on the planned date. Sixty users trained.
We train users, administer the MES and stay alongside production teams, from go‑live through to system changes. When a version upgrade is on the table, we start with a feasibility audit.
Training · Administration · Support and on-call · Version upgrades
Case study
Administration, Business System Owner role and on-call support, within the site’s MES team.
Internal training
Each consultant has an account in Siemens Opcenter Execution Pharma. The system is connected to an ERP, a SCADA and simulated equipment. The first exercises are the basic actions of a production area: identifying equipment, checking it is clean, weighing a material, declaring production. Pharmaceutical scenarios come next.
We also train our clients’ teams, on their own system. See the training case study
Explore our training approachPractical topics to work through with production, quality and the project team.
The Maelo team
Maelo Consulting has existed since 2020. We work on MES projects for pharmaceutical and biotech sites, in GxP environments. Our main expertise is Siemens Opcenter Execution Pharma.
Find Maelo on LinkedInYour point of contact
Founder of Maelo Consulting
An engineer from Mines Saint-Étienne, Mathias has worked on pharmaceutical MES since 2015, starting at Sanofi Pasteur. He has held all the key roles of an Opcenter Execution Pharma project: application expert, stream leader, UAT lead, qualification lead, business owner. He founded Maelo Consulting in 2020.
View his profileOur team is based in France and Belgium. We go where the projects are.
Before we talk
Let’s discuss your project
Tell us where your project stands and what you are missing. Mathias Louis, founder of Maelo Consulting, will answer you.
Let’s talk about your background and what we could do together.
