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ValDevTec, Inc. is committed to providing comprehensive guidance, planning, implementation, and validation services to our clients. Let us guide you through your most complex and critical validation implementation and regulatory issues. We have a team of associates with proven hands-on experience and global expertise to ensure your project is a success.

Our professional infrastructure offers seasoned regulatory experts capable of addressing regulatory challenges effectively and efficiently. We take pride in our work and sincerely want our clients to succeed in their endeavors. ValDevTec, Inc. is committed to quality and our consultants are trained to develop and implement processes and procedures designed to protect and preserve regulatory compliance data.

We work diligently with each client to develop the ideal solution to assist with the success of their projects. We have a strong fundamental understanding of Computer System Validation and the highest confidence in applying all relevant FDA regulations.

Services Overview

A Sample of Our Service Offerings Include:

• Compliance Solutions
• Computer Systems Validation
• Laboratory Equipment Qualification
• Manufacturing Equipment Qualification
• Auditing
• Procedure Development
• Training
• Technology Solutions
• Project Management

For more information about our services, visit our Services Page.

Experience Overview

Some of our experience includes:

Computerized Systems

• LIMS (LabWare, Applied Bio LIMS, Beckman LabManager, Perkin-Elmer SQL) [including interfaces with SAP, laboratory equipment, and other software applications]
• TrackWise
• Clinical Trials Data Management Systems (ClinPhone Clinical and Designer, Clinsight, Entry Point 90, and in house developed applications)

Laboratory Equipment and Software

• Balances
• BioReactor Software (BioXpert)
• Chromatography Data Systems (Atlas, Cerity, Peakpro, TotalChrom, MultiChrom)

Infrastructure

• Network Qualifications (retrospective qualifications, server qualifications, SAN qualifications)
• Remediation/corrective action plans for networks that are not ready to be qualified

Manufacturing Equipment and Software

• API Dual Bundler
• CF 1000 Dust Collector
• CNC Equipment

Development

• LIMS tests, calculations, events, reports
• SAS programs to assist with process and product capabilities
• Access databases

For more information about our experience, visit our Experience Page.

About

Founded in 2007, ValDevTec, Inc. is a consulting firm which provides compliance solutions to pharmaceutical, medical device, biotech, clinical research and related industries. ValDevTec, Inc. consultants have many years of experience and extensive backgrounds in FDA regulations and industry standards. Utilizing a full life cycle validation approach, ValDevTec, Inc. applies a unique blend of technology, business, and regulatory expertise resulting in cost-effective solutions for your business needs.

Contact

Give us a call today and let us help you with your compliance needs.

Samantha Woodall-Freeman
ValDevTec President

P.O. Box 249
Demorest, GA 30535
Phone: 706.778.7835
Fax: 706.778.7836
Email: samantha.freeman@valdevtec.com

Or General Email Contact: contactus@valdevtec.com