Software Validation

One size DOES NOT fit all

Encompass Elements is committed to meticulously prepare and strictly adhere to a System Validation Master Plan in an effort to meet FDA regulatory compliance requirements for handling and distribution of prescription medications and medical device repacking and relabeling. The system will be fully compliant.

Our Validation Master Plan, supporting documentation and employee training will be customized based on the unique software available only at Encompass Elements. This includes:

• ITS - Inventory Tracking System

• RepLink 360 - Online Ordering and Fulfillment System

• Related Hardware and Software

Timeline:

12/20/2009 - Computer System Validation Assessment Complete

During the last quarter of 2009, Encompass Elements contracted with a professional consultant to mentor us through the Risk Assessment Stage.

• Current state assessment documented

• Gap analysis prepared

• Remediation plan documented

06/30/2010 - Expected Completion of Remediation Stage

We expect to complete the Remediation Stage by mid-year 2010. By completion we mean:

• Finalize Validation Master Plan

• Define User Requirements

• Complete all documentation

• Employee training

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PDMA Alliance