About Us

About System E

MES and Project Management Expertise built on over 25 years of Life Sciences Manufacturing experience

We are a cutting-edge consultancy that specialises in the project management of complex software systems. Our main area of expertise is the implementation of manufacturing systems within life sciences.

We have a proven track record over many years of resolving complex project issues while empowering clients to take control of large projects. Our client base comprises 8 of the world's top 10 life sciences companies.

Using well-proven methodologies and processes, we strive to understand your business, your challenges, and will work with you to implement solutions that work for you. We support clients in preparation for, and response to regulatory audits.

Based in Ireland, we deliver MES consulting and project management services across the USA, Europe, and globally. Recent projects span 25+ sites worldwide in therapeutics, biologics, API, and gene therapy manufacturing.

Our expertise is in the following areas:

MES Implementation

Full MES design service from requirements gathering to qualification for pharmaceutical and biotech manufacturing.

Project Recovery

Proven process for rescuing troubled MES and automation projects in life sciences manufacturing.

Regulatory Compliance

Expert support for FDA and EMA inspections, electronic batch record design, and audit preparation.