

Donna Danduone
President, Principal Consultant

MEET
Donna Danduone
Quality. Integrity. Results.
LiSci Services LLC was founded in 2018 to help life science organizations solve complex issues and address short-term resourcing needs.
With extensive experience in life science software development, implementation, training, and validation I approach issues with a holistic view starting with data planning, all the way to regulatory submissions and downstream data analysis. I enjoy working with large and small companies helping to facilitate change, achieve their vision, and improve productivity. My mission is to provide high-quality services, with integrity and efficiency, while providing guidance and inspiration.
Services and terms are tailored to meet each organization's needs. When necessary, additional resources can be brought in from my network of reputable consultants and partner organizations. Not sure how I can help? Please contact me to schedule a complimentary call.
Experience
26YRS
Nonclinical LIMS Software Development & Implementation
CDISC SEND Software Development, Implementation & SEND Services
Project Leadership, Training & Validation Services
Quality Assurance, GLPs, Part 11
12YRS
18YRS
20YRS

Project Strategy & Execution
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LIMS Implementation/Development
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Strategic Project Planning
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Project Execution:
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Software Design/Development
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System Configuration
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Training
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Computer System Validation
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System Implementation
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Maintenance
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GLP and non-GLP Systems
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CDISC SEND Compliance
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Vendor Evaluations & Audits

Project Support
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Business Analysis
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Requirements Definition
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Software Design/Configuration
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Technical Documentation
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Training
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Software Testing/Computer System Validation
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Vendor Evaluations (LIMS and SEND)
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Quality Assurance/Audit Support
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CDISC SEND Services
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Data Analysis

Process Development
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Quality Management System Implementation
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Standard Operating Procedure Development
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Third-Party Vendor Audits
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GLP/Non-GLP
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21 CFR Part 11 Compliance
CONTACT