QA Edge, Inc. is Sparta Certified for
TrackWise® Validation

Because of QA Edge’s internal training efforts, TrackWise certification and industry
experience validating TrackWise, our organization is prepared to rapidly and efficiently
execute a TrackWise validation plan in a cost effective and time-sensitive manner.
QA Edge is able to provide TrackWise validation faster and better than any other
validation firm.

Our goal is to demonstrate that there is a difference in choosing a TrackWise
validation partner, and we will do whatever it takes to meet your company’s
critical deadlines.

Your requirements may include:

• Identifying CAPA requirements and tactics for using TrackWise
• Developing a Quality Plan, Project Management Charter and Work Breakdown
  Structure (WBS) to optimize implementation resources and schedule
• Incorporating risk management to focus validation efforts and minimize cost
• Effectively using testing to validate project status, level of quality, complete system demonstration and obtain end-user acceptance (e.g. with IQ, OQ, PQ)
• Developing SOPs and supporting processes which incorporate best practices and
  minimize bureaucracy
• Creating a validation report which demonstrates the implementation of TrackWise is
  under control
• Managing/implementing change control revalidation

What makes QA Edge different:

• We guarantee our work will pass any FDA inspection
• We successfully validated TrackWise for a number of companies
• We maintain a focus of using established good practices, enabling firms to meet cost,
  schedule and quality goals
• We offer competitive billing rates
• We provide continuous employee training, including our Five-Day
  Validation Boot Camp
• We support an impressive list of satisfied, long-term clients acquired during our
  10-year history
• We will follow your orders, rapidly building a consensus with internal groups to keep
  projects on track

To learn how you can quickly formulate a TrackWise validation strategy, call James Pace,
800.459.3363, Ext 30 or e-mail him at James.Pace@QAedge.com.