An Overview of Manufacturing Software For GMP Production

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Richard Soltero

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May 16, 2013, 1:24:22 PM5/16/13
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Please consider this free-reprint article written by:
Richard Soltero

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Article Title: An Overview of Manufacturing Software For GMP Production
Author: Richard Soltero
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The transition to electronic manufacturing is now at full tilt due to the technological systems developments that has occurred over the last 25 years, and now, electronic manufacturing is the industry standard for manufacturing companies who must comply with current Good Manufacturing Practices (cGMP). There are countless benefits to making the transition to electronic manufacturing, however, small to mid-sized manufacturing companies and the contact manufacturing organizations which support them continue to resist making the switch. Companies are hesitant to make the change due to the cost and amount of time required to switch from paper to electronic manufacturing systems. Companies also want to ensure that profits will be higher and the return on investment (ROI) will be worth the costs.

Numerous systems are available which can provide ROI for electronic solutions, but it is important to choose a system which is most effective and meets a company�s requirements. The return on investment should be considerably greater than the costs needed to solve problems in traditional manufacturing systems. The costs incurred on implementing a new system include the initial prices, maintenance upgrade fees, staff training costs, and the loss of productivity while the new system is installed. Additionally, extra time may be needed to further train staff if employees struggle with the transition away from the paper system. The time and costs needed for implementing a new system should be balanced with the improvements to the productivity and streamlined processes which can be achieved through electronic manufacturing.

Each manufacturing plant or operation is different, thus individually, one must evaluate how effective system automation will be for their operation. Electronic solutions can provide streamlined solutions for quality assurance systems, batch records, manufacturing processes, and projected enterprise planning. Electronic manufacturing solutions are wide-ranging and can often seem more complex than it�s worth, however, electronic solutions can maximize efficiency all of existing systems while causing minimal disruptions. There are many levels and options for system upgrades and electronic manufacturing systems to choose from.

What are the Options?

Electronic Batch Records:

Software products that are intended for supervision and documentation of batch activities through electronic recipes. Examples of electronic batch record products include: Master Control, Batch Master, SYNCADE EBR, MAR-KOV, and InstantGMP-Lite. There is a comparison of these systems at http://www.instantgmp.com/Manufacturing%20System%20Comparisons/Manufacturing-Systems-Comparisons.

Enterprise Quality Systems:

Systems which can optimize quality to ensure compliance, as well as manage all quality processes through a centralized database. System functionality ranges from detection of abnormalities to automatic corrective actions, to common trend analysis. These systems can identify high-risk events, then consequently mitigate or prevent issues through automation, integration, and collaboration. Examples include Paradigm 3, TrackWise, EtQ, and Vivladi.

Paperless manufacturing:

Software which streamlines registration, documentation, and validation processes electronically opposed to using hardcopies/pen and paper. The goal is to facilitate movements of information within organizational departments, and also to investors or suppliers. Examples include Kneat Gx, Paper-Less MES, CIMx-Interax, and InstantGMP MES.

Manufacturing Execution Systems:

Systems which provide promising remedies to solving manufacturing problems by connecting all of a manufacturing business's operations to one centralized database. Examples include Honywell POMs, Werum, aspenONE, HITPHAMS, and InstantGMP MES.

Enterprise Resource Planning:

Software that merges manufacturing into an inclusive information system that can directly connect all departments and ease information transfer within a company. This software enables synergy between all departments such as accounting, human resources, business development, production and purchasing. Examples include Ross Enterprise, Sage ERP X3,Epicor, and SAP.


About The Author: Rick Soltero, Founder of http://www.InstantGMP.com MES, an electronic manufacturing execution system that is web based and Part 11 compliant. He also developed http://www.InstantGMP-Lite.com EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

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