Life Sciences

The Life Sciences sector is massively diverse covering both pharmaceutical and medical device R&D, clincial trials, manufacturing and distribution. Despite this diversity a number of common challenges or requirements are identifiable across the sector.

These include:

  • Materials traceability
  • Systems validation to meet regulatory standards
  • Handling of dangerous and/or regulated substances
  • Dealing with temperature controlled substances
  • Process manufacturing
  • Discrete manufacturing
  • Long product life cycles, including clinical trials processes
  • Market specific distribution and payment processes

ERP for Organisations in the Life Science sector

ERP requirements in this sector will be heavily driven by most of the characteristics mentioned above. In addition to the functional requirements, many organisations in this sector will be required to meet regulatory requirements set down by the US FDA, MHRA, IMB and other regulatory bodies. This can have a significant impact on the duration and cost of ERP (and other system) projects as testing and validation processes must be much more rigorous and formalised than in other sectors. At the distribution end of this sector there are requirements that may not apply to distribution in many other industries. For example extremely fast order fulfilment may be a key requirement where a customer requires a high value device or implant for an emergency patient procedure.

CRM for Organisations in the Life Sciences sector

CRM in the diverse life sciences sector will cover all of the standard CRM processes from opportunity management, customer interaction management and so on. In addition CRM may be heavily embedded in clinical trial processes in some cases.

Lumenia and Life Sciences Organisation

Lumenia has vast experience of working with organisations across the life sciences sector. Lumenia has worked on ERP & CRM projects across pharmaceutical manufacturing and distribution as well as medical device manufacturing and distribution. In addition to ERP and CRM, Lumenia has extensive experience of related projects in this sector including Computer Systems Validation, Electronic Batch Records (EBR) and Electronic Medical Records (EMR).

Client Testimonials

“We chose Lumenia as our support partner for choosing an ERP system and now that the selection process is over I can reflect on what a truly fantastic choice that was and how exceptional the Lumenia consultant who worked with us has been through the process. In each stage of the process, his contribution and attention to detail has been outstanding. His interpretation of vendors’ responses and application to our requirements has been insightful and value added. His application of the process, his dedication, diligence, care and integrity has resulted in a selection for Brunel that we have great confidence in.”

Robin Hilton, Finance Director, Neutrahealth

"Brunel Healthcare have been delighted with our decision to use Lumenia to lead our ERP system selection project. Lumenia applied a very rigorous and thorough methodology to the selection process which forced us to think carefully about what our main objectives were in replacing our current system and what functionality was most important to us in a new system. The knowledge and experience of the Lumenia consultant, and the structured approach to the selection process, allowed us to quickly shortlist a number of potentially suitable solutions and to stay focussed on the most important functionality requirements as we assessed these in detail. We are confident that as a result of working with Lumenia we have chosen a new ERP system that offers the best fit for Brunel’s future business needs and would highly recommend the Lumenia approach in helping us to make this decision".

David Jenkinson, ERP Project Manager, Brunel Healthcare

"The selection of a new ERP system has been one of the biggest decisions for PEI in recent years and we found Lumenia to be an excellent addition to this project. In the first instance our decision to engage Lumenia was not only due to their excellent reputation but also because their independence would ensure PEI an unbiased approach to the selection process. Lumenia helped us identify and document our key requirements and following the scripted demonstrations they worked with us to create an objective evaluation and selection process which assisted us greatly in choosing an appropriate solution. The Lumenia team maintained their independence while demonstrating a strong knowledge of our industry specific requirements and best practices; their experience was invaluable to PEI. If the opportunity arose in the future we would definitely work with Lumenia again.”

Brian Meaney, Financial Director, PEI

" Lumenia has provided EirGen Pharma with strategic computer systems validation expertise since 2009. With their in-depth knowledge of 21 CFR part 11 and EU Annex 11 regulations, they implemented a practical risk based approach to computer system validation for our GxP critical applications and underlying IT infrastructure. Lumenia have successfully led the validation activities on our ERP SAP system, QUMAS Document Management system, and Waters Empower Chromatography system implementations, as well as the qualification of our IT Infrastructure. We at EirGen Pharma rely heavily on our automated systems, we are audited on a regular basis by FDA, IMB and Customers and are confident that our systems meet the required regulatory standards with the validation expertise delivered by Lumenia. I would have no hesitancy in recommending Lumenia validation consulting services."

Patsey Carney, Managing Director, Eirgen Pharma

"Selection of an appropriate ERP system has been a big challenge for Alfa-Pharm due to the lack of the experience in the local market and the absence of the local vendors. Prior to working with Lumenia we went through a lengthy process of negotiations with potential vendors without having expertise on evaluating their proposals and organizing the process. Lumenia’s structured approach was invaluable for identifying an appropriate system and formulating our key requirements. The Lumenia team demonstrated a strong sense of partnership, professionalism and hands-on experience throughout the whole process. I consider this complex project to be one of the most successful we have completed at Alfa-Pharm".

Artur Grigoryan, Chief Executive Officer, Alfa-Pharm

" Lumenia worked with our internal team to develop a comprehensive organisational change management plan for our ERP project and played a mentoring role during the early days of the project. The structure and process Lumenia gave us became a reference point for our team throughout the project. This is a great way to fast-track the change management stream in an ERP project. Highly recommended!"

Joe Smith, Group IS & Service Delivery Manager, Uniphar PLC

"With Lumenia 's assistance we were able to understand how to deliver our complex programme of technology projects more effectively. They provided structure and clarity, supplemented with a great deal of practical experience. I would have no hesitation in recommending Lumenia."

Darren Bradshaw, Director Business Systems, Aptuit

"Congratulations are in order for the outstanding project you and your team helped deliver for Aptuit. Lumenia played a leading role in helping Aptuit to roll out the People Soft ERP system to its newly acquired sites in Oxford and Glasgow. Lumenia supported Aptuit throughout the roll out by providing project management, data migration and computer systems validation services. I would have no hesitation in recommending Lumenia. Your approach was pragmatic, focused and creative. And, your contribution was vital to the success of the roll out project in Aptuit".

Joe O'Donovan, CFO, Galway Clinic

" Lumenia provided us with invaluable assistance during our ERP implementation project, performing key roles on our project team. It was a great asset to our business to be able to draw on such reliable and experienced resources, and I'd highly recommend Lumenia to anyone looking for assistance with business systems projects."

Brídín Quinn, Business Excellence Manager, Abbott Vascular

" Lumenia 's approach was extremely professional and hands-on when we decided to look at replacing our existing systems, from business case preparation through to documenting our requirements, system demonstrations and ultimately choosing a preferred vendor. Our business is diverse and complex, but Lumenia involved people from across the group and helped us focus on the things that make us different or which would be challenging for any ERP system. I've no doubt that the selection process would have been significantly more difficult and lengthy without the help and advice we received from Lumenia ".

David Kelly, Head of Finance, Chanelle Group