Released on: February 18, 2008, 6:55 am

Press Release Author: Thomas R. Cutler

Industry: Software

Press Release Summary: FDA 21 CFR Part 11 Requirements Met for Process Manufacturers
by O2

Press Release Body: 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.


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 (www.evs-sw.com).
\"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
packaging
. 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
century."


Escape Velocity Systems
www.evs-sw.com
Evan Garber
President
solutions@evs-sw.com
303.494.1765 x114



Web Site: http://www.evs-sw.com

Contact Details: Escape Velocity Systems
2530 55th St.
Suite 204
Boulder, CO 80301
303-494-1765