Find out how much you can save by implementing POMSnet!
Find out just how much your digital transformation initiative can save. Whether you are an existing paper based cGMP operations or a new start up the MES ROI is an important step in helping decide if digital is right for you. You can use the ROI tool below to enter business information about your cGMP facility operations and the calculator results will provide a savings estimate.
Major impacted areas for cost savings are adjustable below. Default setting of additional areas are listed in the table below. You can use our industry knowledge defaults settings or adjust to your specific. For addition questions or drill down even deeper contact POMS now to learn more.
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The number of people required to support the compliance lifecycle of a cGMP paper batch records, investigations, and data integrity.
The area of your operations related to performance and cycle time of batch releases with a new automated manufacturing execution system. There are a number of ways thar your operations will improve speed and performance by going digital all while improving quality and compliance. Providing easy to understand user interfaces that clearly guide operators to do correct steps, seamless integration between laboratory testing and manufacturing, and implementing procedures like Review-by-Exception in a validated system.
The top performing companies configure continuous improvement procedures into the digital cGMP workflow for room cleanings and expirations, equipment calibrations and expirations, environmental storage conditions, and providing data and mobility to the whole organization.To get an overview of the impact to total revenue and quality release enter the information below or accept the default value.
Paper batch records inherently introduce a wide variety of day-to-day Data Integrity issues. Companies grapple with managing an unwinnable battle often resulting in overburdening Quality and Manufacturing with excessive training or corrective action and preventative action CAPA investigations that are easily eliminated with POMSnet MES. Many of these exception and deviations are categorized as the following acronym by the Food and Drug Administration FDA, European Medicinal Agency EMA, and the International Society of Pharmaceutical Engineers ISPE.
Attributable – Easily identifiable to the person who did the data collection
Legible – easily readable by an auditor or others
Contemporaneous – The time of data entry should correspond accurately with the real time of data recording
Original – Preserving the authenticity
Accurate – Error free, complete, and viable. No deletions
Sometimes catastrophic failure can occur during production processing that ultimately requires a complete and total loss of raw materials, work in progress WIP, or finished product goods. Life Science manufacturers experience many reasons for this loss from inaccurate testing, not following critical process steps, to failed raw material supplier and not able to track genealogy of raw good through manufacturing. Whatever the case the cost of raw materials, intermediate drug substances or active pharmaceutical ingredients APIs are a devastating loss. We know some customers have biological batches worth of $10 million and a loss is unacceptable. A stable product supply is needed by the patient population who rely on our automated manufacturing execution systems to reliably support manufacturing to supply medications and therapies. For the MES ROI calculation below enter in cost of a batch of finished good product and the number of times this has occurred historically.
You can further edit our assumptions to fit your GMP Facility needs?
Cost of Deviations
The total sum cost of reviewing and completing a minor deviation and CAPA by all staff
Across all departments and benefits the typical salary a company pays out. Also known as "cost per head"
Based on the assumptions above, your results are:
annually and in 5 years!
Your saving will be in 1 year.
The investment for a complete MES can vary widely, and there is really no short cut to determining what the cost will be for your company.
We don't want to offer you anything that won't benefit your business, so we will work with you to determine the most appropriate solution for your GMP Facility!
Tell us about your GMP Facility, and a POMS expert will contact you shortly to provide you a Free ROI analysis on a MES software solution that includes all upfront investment costs, award winning annual support and of course your savings – all in one document.
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Darrell is the Vice President of Sales & Marketing at POMS Corporation. Darrell has over 30 years of professional experience delivering automation and MES solutions to the life sciences, consumer goods, and chemical industries. He is also an esteemed award winner of the ISPE Roger Sherwood Article of the Year published in Pharmaceutical Engineering in 2007, “Unified Manufacturing Control Systems Architecture for Pharmaceutical and Biotech Manufacturing.” He also holds a United States Patent as Co-Inventor of “Flexible Method for Building A Recipe in a Process Control System.”
When people think of POMS they remember Darrell and the meaningful relationships they have built together. Darrell goes beyond MES systems when helping customers understand their business model. He fosters learning, knowledge, and optimism that people absorb and then redistribute back into their organization. Trust is our companies foundation and Darrell helped build it.
Darrell earned a Bachelor of Science in Chemical Engineering from Arizona State University.
Travis has responsibility in all aspects of the ongoing customer experience at POMS, directly managing the Customer Support team. His professional experience is deeply rooted in customer support and customer success across telecommunications, IT management, and software industries. He previously led customer support related organizations at Blackboard and Apptix.
A successful Customer Support team will address all customer needs with a quick, complete, and compassionate resolution – and that is exactly what our team strives to do with every interaction. We partner with our customers to understand their unique manufacturing processes and needs so we can provide the best solutions to ensure their success.
Travis holds a BS in Decision Sciences & Managed Information Systems and an MBA, both from George Mason University.
Krishna is Vice President Software Development at POMS Corporation. His past roles and experiences span engineering, consulting, and product management. Specifically, with POMS, he has over 20 years of experience serving customers globally in the Life Sciences and other regulated industries, enabling them to achieve manufacturing, operational, and business process improvements.
His expertise is in being a hands-on Technology leader leveraging his knowledge in industry domain and emerging technologies to develop and deliver highly impactful software applications. Krishna combines his passion for technology and his focus on customer needs to build industry-recognized, award-winning manufacturing solutions. Krishna also takes pride in leading a highly competent and technically accomplished team of software engineers.
Krishna holds a B.S. in Electrical Engineering from India and a six sigma black belt certification.
Roland is Business Development Manager at POMS Corporation. Before joining POMS, he was an MES Consultant with NNE an international pharmaceutical consulting firm, where he consulted pharmaceutical and biotech companies with MES and Automation Strategies for technology road maps. He has served in technology and system evaluation roles for life science companies in the manufacturing IT and automation platforms.
As a strategy expert, he has an eye for creating value at the intersection of technology and business. He believes in technology driven transformation to enable enterprises to improve the fundamentals of business and stay ahead of the accelerating pace of change.
Roland graduated from UC San Diego with a B.S. in Chemical Engineering.
Cherie is a Quality Manager at POMS Corporation. Before joining POMS, she served in leadership roles with computer system validation and quality groups for both medical device and pharmaceutical companies.
Cherie’s expertise in FDA quality systems and cGMP regulations allowed her to effectively develop and implement a successful Quality Management System that ensures FDA compliance and best industry practices, helping clients with their own validation needs. She also managed the development of a validation tool targeted for clients regulated by the FDA.
Cherie graduated from the SUNY @ Buffalo with a B.A. in Computer Science and a B.S. in Management.
Patrick is a solutions-focused software executive with more than 25 years of experience leading organizations that deliver high-quality production execution software. Prior to joining POMS, he led the software development and product management teams at MAJIQ, an industry leading MES provider to the forest industry.
Patrick has spent extensive time in manufacturing facilities around the world, collaborating directly with customers to design and develop practical applications that address real world business problems. His leadership is guided by POMS’s core values – Empowering Health Sciences, Partnering with Customers for Life, and Fostering Quality & Reliability – and he believes that in the company’s tireless mission to be the MES platform of choice to the Life Sciences industry, how it gets there is just as important as the destination.
Patrick has a BS in Engineering from Texas A&M University, an MS in Engineering from Wichita State University, and has attended the Executive Development Program at the Stockholm School of Economics.