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
Copyright © 2011 Luna Source, Inc