ERA Sciences: Life Sciences Expertise in GMP, 21 CFR Part 11, GAMP5 & Data Integrity

About ERA

ERA Sciences provides cutting-edge solutions to help clients in life sciences and pharmaceutical industries meet their regulatory needs. Our team, led by experts like Dr. Eva Kelly and Andy O'Connor, offers extensive experience in data integrity, GMP, and ALCOA Plus compliance. We specialize in supporting clients with Veeva, CTMS, and data governance, ensuring excellence in 21 CFR Part 11 and Annex 11 compliance and GAMP5 implementation. With a focus on efficient and compliant solutions, ERA Sciences is a trusted partner in the life sciences field.

Experience

At ERA Sciences, we bring over 25 years of expertise across life sciences, pharmaceutical, and medical device sectors.

Dr. Eva Kelly, with a PhD in Chemistry, has led numerous international data integrity remediation projects. Specializing in GMP, 21 CFR Part 11, Annex 11, GAMP5, and ALCOA Plus compliance, she has guided companies in implementing robust data integrity governance strategies. Her experience spans Veeva Vault, CTMS, and other leading on-premise and cloud systems, ensuring seamless integration and regulatory compliance.

Andy O'Connor, with over 15 years of experience in life sciences, has excelled in Application Lifecycle Management and Quality Risk Management. He has collaborated on numerous data integrity projects, helping companies meet 21 CFR Part 11, Annex 11 and GAMP5 requirements. His expertise includes implementing and validating systems like Veeva, Tracelink, Labware LIMS ensuring operational efficiency and compliance in high-stakes environments.

Find out more

Dr Eva Kelly

Eva holds a degree in Analytical Science and a PhD in Chemistry from Dublin City University, with over 25 years of experience in site solutions and learning management across the pharmaceutical, medical device, and FMCG sectors. Specializing in 21 CFR Part 11 and Annex 11 compliance, she has led Data Integrity and QA IT initiatives for pharma and biotech companies, focusing on GxP SAAS solutions. Eva has successfully contributed to international Data Integrity remediation projects and emphasizes the importance of establishing a Data Integrity Governance strategy. With expertise in Application Lifecycle Management, Quality Risk Management, and various software systems like Veeva Vault, EtQ Reliance, and Waters Empower, Eva is committed to helping clients ensure data compliance and excellence.

Andy O'Connor

Andy holds an honours degree in Science from University College Dublin and has over 15 years of experience in Enterprise Application Lifecycle Management in the life sciences sector. His career spans roles such as Validation Lead, QA IT Lead, and Programme Management, with a focus on 21 CFR Part 11 and Annex 11 compliance. Andy has led Data Integrity projects for GxP SAAS solutions and has expertise in Risk Management, regularly hosting Risk Workshops for clients. As an experienced LIMS and Empower practitioner, Andy is passionate about using lean methodologies and Design Sprint techniques to help pharma and biotech companies achieve Industry 4.0 goals while driving process efficiencies.

Ben O'Brien

Ben holds an honours degree in Chemical and Pharmaceutical Sciences from Dublin City University and has over 8 years of experience in pharma, focusing on SAAS and hosted QMS and LMS applications. He has been involved in large-scale GxP implementation projects, with expertise in quality and validation deliverables. A keen innovator and advocate of paperless validation, Ben excels in Application Lifecycle Management (ALM) and is experienced in both Waterfall and Agile Methodology frameworks. His recent work includes Veeva QMS implementation, and he brings a strong focus on lean methodology and software QA test automation to the team at ERA Sciences.

Anna Burzyk

Anna holds a Master's Degree in Engineering from Silesian University, Poland, and has numerous certifications from Technology University Dublin in eBioPharmChem, CSV, and eValidation. With over 10 years of experience in the Medical Device sector, she has held roles in Engineering and Quality, focusing on computer system and software validation. Anna has led lean six-sigma projects and successfully implemented systems compliant with 21 CFR Part 11, Annex 11, and GAMP Ed 2. Her expertise in Risk Management, Change Management, and New Project Introduction allows her to navigate various client solutions at ERA Sciences, while mentoring and coaching teams in regulated environments.

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