Eolus® Compliance Solutions : Team

The Eolus team has over 25 years in the Quality Systems, Software, and Information Technologies.  Eolus has experience designing, evaluating, selecting, building and implementing a wide variety of systems for life science and information technology industries worldwide.

Our principals have extensive experience in software, quality systems, and information technology. We provide audit and management consulting services worldwide.  

CEO, Principal Auditor and Quality Systems Consultant

As Principal for Eolus Compliance Solutions, Ms. Weldon provides systems, and quality consulting and audit services to life sciences and technology organizations worldwide. Her recent experience includes vendor compliance assessments, full quality and systems audits, and conducting ISO and GXP training courses including 21 CFR Part 11 compliance. She has recently led quality systems implementations, and implementations of SDLC and software validation methods and processes.

Ms. Weldon has a strong project management background, a thorough understanding of product design, design control, process control, QSR, GAMP, GLP, GCP, ISO, ICH, SDLC, project management methodologies, and software validation methodologies. In addition, Ms Weldon has experience in a wide variety of systems and subjects from project management, clinical supply and distribution, IVRS/IWRS, EDC, eDiaries, ePRO, eClinical, data management, LIMS, instrumentation systems, medical devices, IVD, inventory control, ERP, CRM, training, to finance and HR.  

Ms Weldon has a strong information systems and data informatics background which includes software design and development, database design, regulatory compliance, product and system development life cycle methodologies, business process design, and software validation.  

Phyllis has been a presenter at Barnett, DIA and PDA meetings on topics relating to project management, and regulatory compliance. She is a published author including articles in the Quality Assurance Journal. She served on the PDA task force, which focused and published the Good Electronic Records Management Document. Ms. Weldon serves on the DIA Peach (previously Red Apple) task force on Computerized Systems in Clinical Trials, “Current Concepts for Data Integrity”

 As previous Chief Information Officer for Duke Clinical Research Institute, with responsibility for the software applications and computing infrastructure to support research activities, she provided systems for study management, supply management, inventory, distribution tracking, site management, randomization and enrollment, document management and data management. 

Subsequent to Duke, she served as Vice President of Compliance Services for SEC Associates, a regulatory compliance company. Ms. Weldon’s experience includes nine years at Burroughs Wellcome Co. While at Wellcome, her focus was leading major development and process improvement projects for enterprise systems, corporate, financial and for clinical trial management. After leaving Wellcome, she founded a auditing and management consulting services company.

As a auditor and consultant, Phyllis focuses upon providing software quality assurance, quality systems audits, systems compliance, security and controls for electronic records, project management, design controls, requirements and business analysis, for life sciences and academic organizations worldwide. 

For Additional Consultant CVs contact us.



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