Fda 21 Cfr Part 11 Requirements Met for Process Manufacturers by O2
Nov 18, 2010 Bakery Recipes
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.”
Tags: Manufacturers, Part, Process, Requirements
Accounting Software 411 Looks at Escape Velocity Systems Auditing and Security for Process Manufacturers
Nov 12, 2010 Bakery Recipes
When one food manufacturer has to contend with hundreds of recipes, ingredient variations, and multiple batches in a single production run, the possibilities for errors are enormous. Seemingly at odds, lean manufacturing principles call for productivity gains which are increasingly dependant upon speeding up the flow of sensitive data throughout the enterprise. This paradox is felt most significantly by thin margined formula-based food processors; according to manufacturing journalist Thomas R. Cutler who recently profiled the role of advanced auditing and security for the process manufacturing sector in the January issue of Accounting Software 411.
While discrete manufacturing systems are generally designed around a bill of material containing whole, or discrete quantities of materials (such as 1 axle, 2 tires), process manufacturing systems are driven by formulas (such as 90% water, 10% flavoring.) Process manufacturers usually blend or mix materials rather than cutting, shaping, or assembling hard goods. Hybrid manufacturers combine process and discrete components. A good example would be a cosmetic company that mixes a batch of lip stick bulk and fills the bulk into a base container (process manufacturing), then assembles this into a finished product with a packaging and label bill of material (discrete manufacturing).
Like the Colonel’s secret recipe, proprietary data is managed through an ERP (enterprise resource planning) system which must be guarded from malicious data tampering. As with regulations, like Sarbanes-Oxley, companies are held accountable for the data that is produced from their ERP system; few have the necessary tools to ensure that the data is managed appropriately by the authorized personnel (although most make claims to the contrary.)
According to Evan Garber, President of Escape Velocity Systems (www.evs-sw.com), which specializes in formula-based process manufacturing, “Advanced auditing and security functionality is not simply preventing unauthorized data manipulation…risk management, it provides a context for a data management plan that includes process improvement.”
Advanced Auditing and Security Drives Continued Process Improvement
Some of the features that technology solutions must provide, particularly among process manufacturers include:
• User accountability for one’s actions
• Managing ancillary attached data (such as Excel or Word attachments) through an approval, lockdown, and version control process
• Managing efficiency of electronic document handling
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 entire article may be read at http://www.accountingsoftware411.com/Press/PressDocView.aspx?docid=9402.
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Tags: Accounting, Auditing, Escape, Looks, Manufacturers, Process, Security, Software, Systems, Velocity
Process Manufacturing Software Firm Evs Excels With Nathan Brown
Nov 2, 2010 Bakery Recipes
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
Nathan Brown is Director of Product Development for Escape Velocity Systems, Inc. (EVS) (www.evs-sw.com). Brown began his career writing commercial software for retail, professional service and process manufacturing industries. In 2001 Brown co-founded Escape Velocity Systems, Inc. (EVS) with the sole mission of providing industry leading process manufacturing software solutions to the small and mid-size market space. Since then EVS has developed two major projects: ProVisio WMS and O2 Process Manufacturing for MAS 500. Brown’s role in these projects included development lead, functionality specialist and management of the development team. Brown is also in charge of implementation services of the O2 product.
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 to President Evan 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.
Tags: Brown, Excels, Firm, Manufacturing, Nathan, Process, Software
