QUALITY ASSURANCE

							         MGD Services, Inc.

          The IT Quality Assurance
         FDA Validation Specialists


              Running with Technology


   Phone: 877-MGD-TEST (877-643-8378)
   Email: gretchen@mgdservices.com
   Web Site: http://mgdservices.com
        FDA Validation
          Overview
All systems that require compliance
 with FDA guidelines must go
 through the validation process
 which ensures compliance.
Validation Task List
          Validation Master Plan

          Validation Library

          SOP’s

          Compliance Reviews

          Traceability Matrix

          IQ/OQ & PQ

          21 CFR Part 11

          Validation Summary Report
Validation Documentation

All software systems that are developed
  or used for FDA submissions or systems
  that are used with medical devises are
  subject to review by the FDA. All
  phases of the Project Life Cycle are
  required to maintain FDA validation
  documents
      Overall Design
      Documentation

The documentation necessary to
 support the overall design of the
 system to be validated.
  Project Management
    Documentation

The management team for the
 project will be required to maintain
 project level documentation as
 well as to establish regularly
 scheduled project meetings.
         Hardware
       Documentation

All of the hardware required to
  support the software systems will
  be required to maintain installation
  and operational documentation.
         Database
       Documentation

The database that supports the
 applications must maintain
 documentation that supports the
 design and capabilities of the
 database.
          Reports
       Documentation

The reports that are generated by
 the system users require
 supporting documentation on the
 setup and capabilities of the
 reports.
     Quality Assurance
      Documentation

The largest area that requires good
 solid documentation is Quality
 Assurance. Before the system can
 be validated the system must be
 tested and all supporting test
 documentation must be
 maintained.
      Change Control
      Documentation

The change control for the system
 under development is critical. All
 changes must be documented and
 all supporting documentation must
 be maintained in the validation
 library.
      21 CFR Part 11
      Documentation

This aspect of FDA validation has
 moved to the forefront of the
 development process. Keeping the
 documentation necessary to
 support electronic signatures is
 critical.
             Validation
              Auditor
   Develops FDA validation guidelines
   Writes Validation Plan
   Performs compliance reviews
   Assists all project team members in
    establishing compliance
   Performs all other compliance activities
    necessary
        In Closing...
  Ensuring FDA validation and
  compliance for our clients development
  projects enables the project to pass
  any FDA validation audit, thereby
  ensuring the system is moved into
  production on time.

MGD Services, Inc.
P: 877-MGD-TEST
Web: mgdservices.com
E-Mail: gretchen@mgdservices.com