Food ERP Leader Escape Velocity Systems Demonstrates Compliance with FDA 21 CFR Part 11 Requirements

Released on: February 8, 2008, 7:13 am

Press Release Author: Thomas R. Cutler

Industry: Software

Press Release Summary: Food ERP Leader Escape Velocity Systems Demonstrates
Compliance with FDA 21 CFR Part 11 Requirements

Press Release Body: The FDA specifically states that the \"agency expects the
magnitude of these benefits should significantly outweigh the costs of making these
system.\" Easily obtained ROI include benefits derived from adhering to 21 CFR Part
11 regulations include:

. Reductions in system vulnerability and abuse
. Lower regulatory or compliance driven costs
. Shorten validation time
. Reductions in entry errors
. Reduction in costs related to record retention
. Improved data integration and modeling capabilities
. Increased speed of information exchange

According to Evan Garber, President of Escape Velocity Systems (
\"O2 software has built in controls necessary to obtain validation from the FDA.\"
Created by Food and Drugs Administration (FDA) in 1997, 21 CFR Part 11 requires FDA
regulated companies to adhere to a specific set of requirements for computerized
systems, electronic records, and electronic signatures.

Process Manufacturing describes a manufacturing process whereby materials are
blended, cooked, or mixed as opposed to assembled from discrete units. Some needs
common to process manufacturing industries are:

. Formulas (or recipes) are ratios, not static bills of material
. Split bill of material: several products can share one formula, yet have different
. Flexibility with units of measure
. Stringent quality control, with recall ability
. Lot grading / attribute tracking and calculation

Escape Velocity Systems (EVS) was formed in 2001 to combine specific industry
knowledge related to process manufacturing, distribution, and ERP implementations
with cutting edge software development. The company focus is to create tools that
enable mid-market enterprises to achieve their goals, focusing on lean processes and
ROI. According Garber, "We realize that good ERP software is the hub of
information in any process manufacturing enterprise. Timely, reliable, and
centralized data are non-negotiable elements for businesses competing in the 21st

The term escape velocity refers to the speed that is necessary for an object to
overcome gravity and soar into space. EVS provides direct applications for
businesses looking for a catalyst, not just a software package. Process
manufacturers require the best software solution coupled with industry experience
that will accelerate the velocity with which they race towards their goals. The
gravity of status-quo opposes aggressive, cutting edge organizations as they strive
towards high quality and short lead time delivery while reducing inventories and
operating costs.

Escape Velocity Systems
Evan Garber
303.494.1765 x114

Web Site:

Contact Details: Escape Velocity Systems
2530 55th St.
Suite 204
Boulder, CO 80301

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