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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