QA Edge solves these SAP problems for our clients:
    
- SAP changes costing too much.
     - SAP validation is complicating the project and is not risk-based.
     - The need to know the benefits of SAP.

QA Edge understands that high-performing organizations want to:
     -
Decrease the cost of each SAP change
     - Improve the probability of success for each change
     - Shorten the duration needed for each change

They also want regulatory (FDA/SOX) compliance to be unobtrusive, repeatable and easily
explainable.

The partnership between QA Edge and Revelation Software Concepts, maker of Rev-Trac®
software for integrated SAP change control, enables us to provide solutions for these
challenges by offering you, and other FDA-regulated firms, an improvement in your change
control programs.  These improvements will lower your cost and make compliance with
regulatory requirements automatic.

QA Edge has developed a fast-track validation program for Rev-Trac - making implementation
and validation quick and easy. In addition, QA Edge is a Gold Partner with Mercury Interactive
offering solutions for using automated testing tools like Quick Test Pro (QTP).  These
improvements also lower costs and improve the speed for completing testing and re-validation requirements.

SAP Changes

Is managing SAP change problematic for you in any of the following:
     -
80/80 rule: 80 percent of our downtime is caused by unplanned or poorly
       executed change and 80 percent of our mean time to repair (MTTR) issues is spent
       on trying to determine what changed.
               - How can we stop self-inflicted work and how much extra work could be avoided?

     - The more complicated the change process is, the less likely it is fully and consistently
       followed by the change staff.
               - Can we reduce the number of steps in the process and at the same time easily
                 respond to compliance audits?

     - Metrics are not collected and measured which could help us identify opportunities for cost   
       reduction and improvements in throughput speed.
               - Can we make the process more visible and foster continuous improvement?

Then take the next step: Request a Change Management Benchmark Assessment (CBA)
quote which will demonstrate exactly where your operational deficiencies and compliance
gaps exist.  We’ll also suggest actions you can take to improve maturity and lower your
costs. If you are aware of your issues, then share the problems that you want solved
and we will schedule a session that reveals how they can be corrected using Rev-Trac®.
Then, you decide.

Links:
Rev-Trac Data Sheet (PDF)

Rev-Trac Whitepapers:
     -
Managing an SAP Solution Upgrade with Rev-Trac
     - Ten questions to ask when deciding how to manage changes to SAP solution-based
       business intelligence systems
     - Issues in Change Management for SAP Solutions: An RSC Guide

Rev-Trac Customer Stories
     - Textron uses Rev-Trac to … (full story)
     - Unilever uses Rev-Trac to … (full story)
     - Morris Publishing Group uses Rev-Trac to … (full story)

For more information on how QA Edge may be of assistance, please contact Joseph Schenk
at 800-459-3363, Ext. 11 or e-mail Joseph.Schenk@QAedge.com.

SAP Validation

If your SAP validation efforts are complicated, confusing, and changing, you are not alone.  If compliance is resisted because company processes are inconsistently applied and are
perceived as value draining, you are really not alone.

Many firms forget the real objective of computer validation: To provide credible, timely
and valuable information to the stakeholders about project progress and the
level of quality of a system.
Anything else is a futile activity to create documents -
which someone, somewhere, believes may pass a regulatory inspection.

Our Solution: The experienced team of QA Edge professionals can help develop and
execute strategies for rapid validation. We combine full compliance with your SOPs
with innovative use of low-tech and high-tech tools (e.g. Mercury’s testing tools) to
rapidly deliver the information that the project team and stakeholders need in order to
know the TRUE status of the project.

Plus, we offer the industry’s only GUARANTEE that work authored by QA Edge will pass
any FDA inspection.  If your validation team isn’t delivering this, then you are wasting your
precious funds on creating paper for binders that will probably never be read and will
most likely be wrong.

For more information on how we can help, please contact Joseph Schenk at
800.459.3363, Ext. 11 or e-mail Joseph.Schenk@QAedge.com.

SAP Benefits

High performing medical device firms look to SAP to:
     -
Uncover methods for reducing inventory carrying and scrap costs
     - Unlock and increase capacity “capabilities” utilizing existing fixed assets
     - Model and simulate operations to discover and remove process bottlenecks and
       constraints with the goal to reduce per unit costs
     - Reduce ongoing Quality Assurance and Compliance costs per unit (and litigation/
       discovery costs) by improving process audit-ability and delivering actionable process
       control analysis
     - Reduce their “change-over time” and improve business process adaptability as new
       products, product enhancements, new customers, and new channels are added
     - Deliver executive-level confidence in financial reporting aligned with SOX
       requirements
     - Improve product traceability in order to reduce recall costs
     - Reduce per unit costs by optimizing sourcing and supplier management
     - Increase gross margins by enabling their sales force with accurate pricing
       information and flexible contract volume options
     - Reduce the integration speed of their new business units and acquisitions

How about you? Not implementing SAP could provide your competitors a swift and
unreachable advantage. However, your firm may have been cautious about implementing
SAP because of the time, complexity, and validation unknowns. 

Our Solution:   QA Edge has teamed with a key SAP partner to develop a fast and
reliable validation strategy on a project based on a four-to-five month implementation! 
Our partner has developed pre-configured templates designed for small- to mid-market
medical device firms to reap the benefits of SAP that large firms have - without the high implementation and validation costs. 

For more information, please contact Joseph Schenk at 800.459.3363, Ext. 11 or
e-mail Joseph.Schenk@QAedge.com.

Computer Compliance Made Easy