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Bridging the gap between science and technology

Synthesizing complex issues into simple, actionable plans for success.

Home: Welcome

Donna Danduone

President, Principal Consultant

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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.

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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

Experience
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Project Strategy & Execution

  • LIMS Implementation/Development

  • Strategic Project Planning

  • Project Execution:

    • Software Design/Development

    • System Configuration

    • Training

    • Computer System Validation

    • System Implementation

    • Maintenance

  • GLP and non-GLP Systems

  • CDISC SEND Compliance

  • Vendor Evaluations & Audits

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Project Support

  • Business Analysis

  • Requirements Definition

  • Software Design/Configuration

  • Technical Documentation

  • Training

  • Software Testing/Computer System Validation

  • Vendor Evaluations (LIMS and SEND)

  • Quality Assurance/Audit Support

  • CDISC SEND Services

  • Data Analysis

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Process Development

  • Quality Management System Implementation

  • Standard Operating Procedure Development

  • Third-Party Vendor Audits

  • GLP/Non-GLP

  • 21 CFR Part 11 Compliance

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CONTACT

Tel: 973.615.2040

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