Luna Source, Inc.: Networking Technology

Regulatory Compliance and Laboratory Systems

We provide a wide selection of skilled consultants for our FDA Regulated clients. These skill-sets may involve the following types of positions:

	Software Quality Compliance Analysts	LIMS Support
	Software Validation Specialists	IT Auditors
	Quality Assurance Specialists	LIMS Design / Configuration
	Laboratory Systems Specialists	LIMS Basic Programming
	Equipment Validation Specialists	Crystal Reports
	Technical Documentation Writers

The consultants we provide can vary in skill sets and function, as well as, required experience. For our Junior Level positions, the minimum requirement is 3+ years of technical experience. For our Senior Level positions, we require 8 to 15+ years of technical experience.

Total IM Compliance Support
Remediation / Validation
IQ / OQ for Software & Equipment
Change Control Requests
Gap Assessment Report
System Application Forms (SAF)
Change Control Request (CCR)
Project Planning Form (PPF)
Validation Strategy Documents (VSD)
Software Contractor Qualification (SCQ)
Requirements Specifications (URS, PRS and SRS)
Validation Protocols
Traceability Matrix
Standard Operating Procedures
Training Materials
Project Management

One or more of the following skills may be required in any of our positions:

Validation Plans	Validation Reports	IQ, OQ, PQ
Gap Analysis	Audits	GxP Regulations
Test Protocols	Requirements Specs	cGMP
Risk Analysis	Processes / Procedures	GAMP4
21 CFR Part 11	QSR Regulations	SOP's, etc.

Unlike other companies who spread themselves too thin (by trying to do everything for everyone), our goal is to be your company of choice for all your Regulatory Compliance and Laboratory Systems consulting needs.

Phone: (786) 268-1944 / Fax: (786) 268-1945
Luna Source, Inc.
1031 Ives Dairy Road Suite 228
Miami, FL 33179
E-mail: recruiting@lunasource.com