Food ERP Leader FDA 21 Requirements Compliance

by : Thomas Cutler

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:

&bullReductions in system vulnerability and abuse
&bullLower regulatory or compliance driven costs
&bullShorten validation time
&bullReductions in entry errors
&bullReduction in costs related to record retention
&bullImproved data integration and modeling capabilities
&bullIncreased 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:

&bullFormulas (or recipes) are ratios, not static bills of material
&bullSplit bill of material: several products can share one formula, yet have different packaging
&bullFlexibility with units of measure
&bullStringent quality control, with recall ability
&bullLot 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."

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.