Eva leads the Data Integrity and Reliability Modules.

Dr. Eva Kelly has a degree in Analytical Science and a PhD in Chemistry from Dublin City University (DCU) with 30+ years supporting Life Sciences and Med Tech. She has certifications in Data Integrity, GAMP, Quality Risk Management, is a certified lead auditor for ISO 9001:2015, is a Green Belt in Lean and has achieved numerous trainer certifications and awards during her career. Eva regularly supports regulatory audit preparation activities on behalf of Life Sciences clients with a focus on Quality excellence and Data Integrity.

Ben leads the Stakeholder Management Module.

Ben has an honours degree in Chemical and Pharmaceutical Sciences from Dublin City University. He has worked within Pharma for over 8 years and held several roles in Quality with a focus on SAAS and hosted QMS and LMS Applications. He has been involved in many large scale GxP implementation projects and understands expectation management across multi stakeholder groups. Leaving a management role in Pharma to join ERA Sciences, Ben is driven to excel and seek new opportunities and look for innovative smart solutions to IT problems.. He was an early advocate of paperless validation and continues to lead up our CSA initiative, driving automated validation solutions and bringing a renewed focus and energy for lean methodology to ERA and clients alike.

Andy leads the Risk Management and ALM Modules.

Andy has an honours degree in Science from University College Dublin. He has over 12 years of Enterprise Application Lifecycle Management experience in the Life Sciences sector. His career portfolio covers a spectrum of roles including Validation Lead, QA IT Lead and Programme Manager. He has collaborated on many Data Integrity projects for 21 CFR Part 11 and Annex 11 compliance for GxP SAAS, hosted and on-premise solutions. Andy has extensive experience in Risk Management and Risk Perception and regularly hosts Risk Training sessions and workshops on behalf of clients.

Anna supports the Data Integrity and Reliability Modules and has specialized knowledge in CSV.

Anna has a Masters Degree in Engineering from Silesian University Poland. She has achieved many additional certifications including those from Technology University Dublin (TUD); in eBioPharmChem, CSV and eValidation. Prior to joining ERA Sciences, she worked for over 10 years in the Medical Device manufacturing sector, where she held Engineering and Quality roles. Her experience ranges from design and development of measurement systems to extensive computer system and software validation.
Anna has applied her knowledge of 21 CFR part 11, Annex 11 and GAMP Ed 2 to many successful computer system implementations and continues this journey at ERA Sciences. She is passionate about software development and loves working with source code.
"I strongly believe embracing change is key to successful introduction of any new technology including data and CSV solutions and would be delighted to support you on your journey”