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Process and systems to support the bio-economy banner
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Process and systems to support the Bioeconomy
Process and systems to support the Bioeconomy 700 500 Xcelpros Team

The public benefit gained through biological research can be seen through the eyes of a patient who receives a critical medication that did not exist a decade ago, a farmer whose higher-yield crops are turned into fuels, food, and intermediate chemicals, and a small-business owner whose innovative biobased products are breaking new ground in manufacturing. Increased societal needs for food and energy, combined with new knowledge/discoveries in biology and new methods for harnessing biological processes, have dramatically increased the economic potential of the bioeconomy.The National Bioeconomy Blueprint

Introduction

Though written in 2012, The National Bioeconomy Blueprint contains some information valuable to any company wanting to explore the bioeconomy. Critical elements are investments in research and technology.

“… If we want the next big breakthrough, the next big industry to be an American breakthrough, an American industry, then we can’t sacrifice these investments in research and technology,” then-President Barack Obama says in the report. The White House authored the report.

Government agencies at the time were supporting the bioeconomy by:

  • Identifying research and development (R&D) methods
  • Developing foundational transformative technologies
  • Integrating approaches from engineering, physical sciences and computers
  • Improving predictions of vaccine and drug toxicity and efficacy
  • Identifying and characterizing any microbial organism, including purely synthetic versions
  • Creating “science enclaves” that allow analysis of large, complex datasets while maintaining proprietary information.

The report also wanted American industry to increase investment in and production of biofuels, replacing fossil fuels with biomass systems.

Other tasks cited in the report included converting carbon dioxide into liquid fuels, improving biofuel and energy crops, developing new agricultural research programs that drive job creation and transforming manufacturing through bioinnovation.

Some of these tasks have already shown results.

Recent Biotechnical Innovations

A 2020 post on the Klabtree Blog lists 10 biotech innovations.

One of them is CRISPR-based platforms. An acronym for clustered regularly interspaced short palindromic repeats, CRISPR technology was used to create the Pfizer-BioNtech and Moderna Covid-19 vaccines. Other medicines are also using the same technology.

The CRISPR tool, “is based on a system that bacteria use to fight viruses. Bacteria develop clustered repeated sequences in their DNA, known as CRISPRs, that can remember dangerous viruses and then deploy RNA-guided scissors to destroy them,” an article in Time magazine states.

Unlike a DNA-based product that targets a cell’s nucleus, messenger RNA (mRNA)-based vaccines just need to get into the more accessible outer regions of cells where proteins are built.

Using CRISPR technology to accomplish this task, both companies were able to produce Covid-19 vaccines that meet FDA emergency standards. The Pfizer-BioNTech vaccine, now known as Comirnaty, uses its regular, non-emergency procedures. The “regular” and “emergency” variations share the same formula, the FDA states.

Another technological innovation cited by KolabTree that is still being developed involves using DNA as a computer hard drive. The concept would turn cells into data storage chambers with the not-yet-realized ability to store information similar to current data storage.

A third innovation is using base pairings of DNA and RNA nucleotides in what is known as “DNA origami” after the Japanese paper folding art form. Nanovery is using this technology to create diagnostic nanorobots. The robots are inserted into a blood sample. When cancerous DNA is found, the robots light up.

Bioeconomy Business Strategies

Having the technology to turn biological products such as corn husks into fuel does not generate money. Having people who can see profits in the bioeconomy does.

“Entrepreneurs can contribute to the (bioeconomy transformation) by commercializing innovative technologies through startups and new business models,” Andreas Kuckertz writes in a white paper published through MDPI.com.

Figue: 1Bioeconomy Business Strategies

Bioeconomy Business Strategies

Using his research, key strategies for the United States mentioned by the author include:

  • Regulatory framework: Creation of tax breaks, reducing regulatory barriers and helping entrepreneurs obtain and defend patents
  • Market Conditions: Use the public procurement process to speed market adoption
  • Access to Finance: Support the bioeconomy by using venture capital for startups
  • Knowledge Creation and Diffusion: Educate entrepreneurs, connect them to mentors and educate government agencies about entrepreneurship
  • Entrepreneurial Capabilities: Enhance university entrepreneurship
  • Culture: Create an overview of available prizes and awards (mentioned in the National Bioeconomy Blueprint)

Kuckertz suggests modifying these strategies to include those that are:

  • Holistic and based on a clear, causal rationale
  • Include policies with measures tied to clear key performance indicators (KPIs) that can measure progress
  • Have, “dedicated innovation programs accounting for the specifics of bioeconomic innovation will be required to recognize the potential of many promising and possibly game-changing entrepreneurial initiatives.”

While Kuckertz’s comments are oriented at new business development, these same strategies can be used by existing companies. One way is by taking advantage of current cutting-edge business technology: Enterprise Resource Planning (ERP) software.

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Common Themes in Bioeconomy Products

Each of the previous technological innovations has at least three common themes:

  1. 1.Collecting massive quantities of data, also known as “big data.”
  2. 2.Analyzing it and making sense of what is found. Researchers can pour over spreadsheets and try to understand the data or they can use software. Machine learning (ML) and artificial intelligence software helps find the nuggets. These are the test samples that show a formula’s promise while also listing all of the others that don’t.
  3. 3.Safely storing this information away from prying eyes and competitors.

The good news for many companies is the technology to accomplish these three tasks exists today.

The industrial internet of things (IIoT) lets companies gather big data. ERP software is adept at many tasks, one of which is using artificial intelligence (AI) to provide business insights.

Cloud data storage is generally considered to be more secure than that on many small and medium business (SMB) internal networks, using the Microsoft Azure platform to run Windows-based products, adding extra layers of security and reliability.

Microsoft Dynamics 365 AI is designed to help businesses gather insights into customer needs and experiences. It helps companies accelerate a single process and lets groups solve problems and make decisions based on the data.

Microsoft Azure’s cloud computing service provides a stronger, safer and much more resilient computing platform than the average SMB network. It also has the advantage of making data easily accessible from anywhere in the world, all without compromising data security.

The Bottom Line

The bioeconomy is slowly making inroads into various industries. The chemical and pharmaceutical fields are perfectly set-up to take advantage of reusable biological materials such as corn husks for fuel. Other materials can be used to produce less toxic plant-based solvents.

Making money from the bioeconomy requires not only forward-thinking investors who care about the environment, but also advanced technology like Microsoft Dynamics 365 to make sense of it all.

REFERENCE:

Top 10 Biotech Innovations you should know about

How Sustainable Operations Helps Manufacturers Grow
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How Sustainable Operations Helps Manufacturers Grow
How Sustainable Operations Helps Manufacturers Grow 700 500 Xcelpros Team

Introduction

Every business leader has heard the term “sustainable manufacturing,” but not all know that practicing methods that help the environment can also grow their business.

“Sustainable manufacturing is the creation of manufactured products through economically-sound processes that minimize negative environmental impacts while conserving energy and natural resources,” the United States Environmental Protection Agency states. These same practices enhance employee, community and product safety in part by producing less waste that pollutes the air, water and soil.

According to the EPA, companies that use a methodical, planned approach to sustainable manufacturing processes:

  • Increase operational efficiency by reducing costs and waste
  • Respond to or reach new customers and increase competitive advantage
  • Protect and strengthen brand and reputation and build public trust
  • Build long-term business viability and success
  • Respond to regulatory constraints and opportunities

Fostering Growth

These environmentally friendly sustainable manufacturing practices help companies grow by reducing production costs long term. For example, instead of paying thousands of dollars each month to an electric company to light and cool a 300,000 square-foot manufacturing plant, consider covering a flat roof with efficient solar panels.

The average payback time for a home solar electric installation (industrial estimates were not available) is roughly 6-10 years, though it varies depending on the climate and other factors. Solar panels also tend to last 25-40 years meaning roughly three-quarters of their useful lives is spent generating free electricity. The most recent designs are much more efficient, producing more power in a smaller size, than those made 10 years ago. The result is greater efficiency, allowing manufacturing facilities to cover less of their roofs while producing as much or more power than the older models.

Production plants can also reduce their massive electrical bills with skylights. The waterproof domed coverings help illuminate work areas, reducing the need of electric lighting. Extended exterior shelves can reduce sunlight, cutting cooling costs.

Figure: 1 Sustainable Manufacturing – a Big Picture

Sustainable Manufacturing - a Big Picture

Turning Trash Into Treasure

Other sustainable methods look at ways to reduce waste, especially by converting some “trash” into new products or using it for new methods.

One website alone lists 35 artful ways homeowners can recycle wooden pallets. These new uses include making tables, bed frames, stairs, mounting frames for heavy electronic display monitors and a host of other uses. Many of these same methods work for industrial companies in terms of outfitting conference rooms and other non-work areas.

From an industrial perspective, worn pallets can be repaired, cleaned and reused. They can also be sold, recouping some of the cost. Other uses for worn pallets include chipping them, turning them into wood pellets. The pellets can then be burned, generating heat and electricity.

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Cascading Chemicals

Recycling is a large part of the sustainable “green” economy. Industrial chemicals can be recycled. They can also be reused through a process known as “industrial symbiosis,” greenbiz.com states. One example cited uses ferric chloride, which is a byproduct of steel pickling in hydrochloric acid, to treat water.

“Frequently, recycled chemicals are not only cheaper than newly produced ones, but they also reduce resource consumption, waste generation and greenhouse gas emissions. The carbon emissions through solvent recycling are 46 percent – 92 percent lower than those of new solvent production,” the website states.

When the article was written in 2019, industrial giants Siemens and Evonik were conducting research to convert the most common greenhouse gas—carbon dioxide (CO2)—into common industrial chemicals such as ethylene.

Other methods used to reduce chemical and industrial waste cited by greenbiz include swapping what might be one manufacturer’s trash with a different nearby business. That business can use these materials in its products.

Another environmentally friendly industrial method is “leasing” chemicals. In this model, a manufacturer sells the functions performed by the chemical using functional units, not the chemicals themselves.

Large manufacturers with their own wastewater treatment plants can redesign those facilities in ways that help the company turn a profit and grow. Companies interested in practicing sustainable manufacturing practices can modify existing equipment to produce energy, clean water and chemicals because, “the future of sewage is power and profits.”

The greenbiz.com article ends with a quote made in 1848 by the former president of the London Royal College of Chemistry, R.W. Hoffmann: “In an ideal chemical factory there is, strictly speaking, no waste but only products. The better a real factory makes use of its waste, the closer it gets to its ideal, the bigger is the profit.”

Technology Can Spot Opportunities

One way a company can practice sustainable operations management is by using its data wisely. Especially in forward-thinking firms that use internet of things (IoT)-enabled devices, they have access to mountains of information.

Combining a well-thought plan with the right software lets these firms look at everything coming into their warehouse—including packaging—as potential profit sources. Enterprise resource planning (ERP) products such as Microsoft Dynamics 365 and its Supply Chain Management Module let companies of any size keep accurate track of their inventories. Add in the Integrated Chemical Management component and chemical manufacturers have an accurate label management solution that also produces safety data sheets.

By understanding the chemicals involved and working with sustainability experts, plant managers can evaluate their current conditions.

Executives interested in sustainable production and consumption—and being more competitive—will want to ask questions similar to these: What current waste products and materials can we use for secondary purposes or repackage and sell to someone in a different industry? Can we reuse packing materials we receive to pad and protect outgoing shipments? Are we using our raw materials effectively or are there ways we can become more efficient? How much power do our plants use? Are there affordable ways of reducing that consumption while also generating some of our own power all while meeting our long-term business goals?

Asking questions like these, and then using powerful software to find the answers, help innovative firms generate more money. That in turn can use sustainable practices to fuel growth.

The Bottom Line

Sustainable manufacturing involves looking at everything a company has, from a different angle. More office employees are working from home, freeing up space. Can we use that space for a different purpose instead of looking at empty desks? Can we move items around and expand our production facilities or our warehouse without having to build or buy new facilities?

Operations managers wanting to fuel growth by reducing power consumption can use ERP software to find ways to save money and new ways to make money. All it takes is a little outside the box long-range thinking.

How Microsoft's ERP System works with the Retail Industry
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How Microsoft’s ERP System works with the Retail Industry
How Microsoft’s ERP System works with the Retail Industry 700 500 Xcelpros Team

The Changing Retail Industry

With the rapid pace of changes in the retail industry, especially some of the more dramatic changes that have emerged over the past few years, it’s become increasingly important to have full control over your business. Now more than ever this means investing in software that supports the changes seen across the retail industry in recent times, and into the future.

Today’s retail consumers are much more informed, and looking for a safer, more streamlined experience regardless of purchases made online or in-person at brick and mortar locations, which are still very much in demand. The omnichannel shopping experience is quickly becoming a key point to longevity in the retail industry. This means offering a safe and consistent shopping experience, integrating your CRM, ERP and eCommerce systems for a more unified view of your customers, and being able to quickly scale and adapt to support new applications and services as they develop.

96%

of emerging businesses that excel in their respective industry rely on some form of ERP solution.

Source: Aberdeen Group

15%

of executives believe AI could fundamentally change which companies win and lose.

Source: UST SmartOps, 2020

36%

Small businesses with ERP systems can make decisions with 36% less time than they did without the solution.

Source: Aberdeen Group

This has become a great opportunity for retailers to modernize and streamline their operations which can lead to greater long-term profitability as the industry continues to evolve. For this, businesses need a complete solution like Microsoft’s Dynamics 365 Commerce, the evolution of their Dynamics 365 Retail product line, able to offer a complete and unified solution across different channels with maximum scalability.

Microsoft Dynamics 365 Commerce

One of the first words when it comes to enterprise planning, Microsoft has been developing their Dynamics 365 products for many years, and the latest version of Microsoft’s Dynamics 365 Commerce offers unparalleled access to a lot of cutting-edge technology for businesses in the retail industry.

Microsoft’s newest retail ERP solution helps streamline many different areas like merchandising, inventory and order management, warehousing, financials and more. In fact, the exact same technology powering Dynamics 365 Commerce has been driving Microsoft’s storefronts around the world for years to deliver a secure, scalable, compliant solution that offers a world-class shopping experience.

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These are just a few more ways Microsoft Dynamics 365 Commerce supports businesses in the retail industry.

Figure: 1Microsoft Dynamics 365 Retail ERP Solutions

Microsoft Dynamics 365 Retail ERP Solutions

Omni-channel shopping experience

With today’s consumers focused on quality, the right software helps ensure the experience is the same across different devices online and in-store with the ability to offer more increasingly popular options like Buy Online Pickup In-Store (BOPIS), curbside pickup and next or same-day shipping. These trends are becoming staples for many looking to avoid long lines and queues.

Powerful customer insights

Even now, customer data has become extremely valuable for driving AI and ML solutions to create personalized experiences designed to boost sales and increase customer retention. Microsoft Dynamics 365 Commerce is built with AI and ML in mind to further enhance customer engagement along with the ability to integrate to other Microsoft products like Dynamics 365 Customer Insights and Dynamics 365 Fraud Protection.

Warehouse and inventory management

Growing to be equally important is the ability to more accurately predict and manage product stock levels along with up-to-date pricing. Today’s customers don’t want to chase phantom stock counts from store to store when they can easily give their business to another retailer, right from the comfort of their home.

Powerful Integrations

Microsoft’s Dynamics 365 products have always been highly adaptable and configurable, able to integrate with numerous existing applications and services offering a unified experience across different platforms. Microsoft Dynamics 365 Commerce is no different, able to directly connect to a multitude of modern and legacy systems for reporting, compliance, and more to help protect your investment in previous systems.

What’s Next

As emerging technologies like Artificial Intelligence (AI), Machine Learning (ML) and Augmented Reality (AR) continue to advance, the retail industry will continue to be fraught with the challenge of trying to keep up – including providing modern, personalized shopping experiences to today’s savvy consumers to help retain loyalty across different channels. More and more businesses in the industry are looking for technology partners that understand their challenges and can offer support for modern solutions.

Microsoft Dynamics 365 Commerce is a scalable solution that can be made to work for anything from SMBs to larger multi-brand or multi-company organizations helping Increase your revenue and brand loyalty with better engagement. Better focus your operations to reduce costs and boost efficiency over your entire supply chain.

How an ERP system can help improve Manufacturing performance
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How an ERP system can help improve Manufacturing performance?
How an ERP system can help improve Manufacturing performance? 700 500 Xcelpros Team

At a Glance

  • Installing modern enterprise resource planning (ERP) software comes at a high cost for manufacturing companies. They want to use their software investments to maximize manufacturing performance.
  • Manufacturers can best use their ERP model by letting their production line and vendors work in tandem with the software to streamline processes.
  • ERP systems are no longer a part of the business backend. Newer tools and applications like cloud computing, Internet of Things (IoT) and Machine Learning are changing ERP systems. All of these technologies affect overall return on investment (ROI).

Introduction

The general benefits of using a comprehensive tool like ERP are well known by most manufacturing organizations regardless of size. However, there are still ways with which ERP systems can be used to better overall operational efficiency in manufacturing, streamline existing processes and improve the production line. How solutions like ERP become the catalyst in generating ROI are usually the difference-makers for the manufacturing sector.

Mid-size businesses’ adoption of ERP software will grow at a CAGR of 7.9% from 2014 to 2020.– alliedmarketresearch.com

As more companies modernize their ERP, they want to understand how they can adapt and manipulate their current practices to maximize their technology investments. First, understand how ROI is calculated in terms of ERP in the manufacturing industry.

Figure 1:Determining the ROI of Manufacturing ERP

Determining the ROI of Manufacturing ERP

Calculating the ROI for ERP Manufacturing: A Comprehensive Look at the Benefits of Installing an ERP System

Every organization has specific short and long term goals in mind when installing an ERP system. While the ROI might be a relative concept for every manufacturer, certain common areas can help decide the benefits an ERP system brings to your company:

  • Does the ERP system help streamline production processes and improve overall production line efficiency?
  • Does it reduce human intervention, lowering the cost of labor for data management and analytics?
  • Does it help better manage purchases, procurements and inventory?
  • Does it provide real-time visibility across the production line for improved communications and faster response times?
  • What other tangible benefits in terms of cost savings and profit gains can you see after installing the ERP system?

Answering these questions lets you calculate the ROI for your ERP.

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The Road to Better Manufacturing ROI: Improving Manufacturing Performance with ERP

01.Efficient Machine-to-Machine and Machine-to-Human Interaction

In today’s cloud-dominated software world, everything is connected through the Internet. Manufacturers can enhance their ecosystems by making real-time connections between the workforce and machines. When everyone from the top floor to the shop floor can view the entire production line, it lets skilled workers use smart manufacturing techniques to save time and effort.

Using ERP software to adopt smart manufacturing techniques helps manufacturers avoid production delays while efficiently tracking material and equipment. Using these methods will generate significantly more revenue.

Figure 2:ERP in the Manufacturing Industry

ERP in the Manufacturing Industry

02.Better Inventory Management

Large-scale manufacturers can afford to hire a larger workforce to manage their inventories. Small and mid-scale businesses lack that luxury so inventory problems can cause financial losses. Efficient larger companies are looking for a centralized network that can keep track of raw materials, incoming and outgoing shipments plus maintenance schedules.

A sturdy, modernized ERP system is designed to handle these tasks where older legacy platforms fail.

ERPs allow companies to get real-time data on their inventory, allowing them to better predict and manage inventory. Every manufacturing company—large or small—understands that accurately managing inventory is a must if it wants to avoid stock-outs and related production delays. A robust ERP system improves ROI by helping manufacturers more accurately manage inventories.

03.Forming a Competent Skill Base

Advanced software and or mechanical tools can only help boost ROI when the workforce is trained in how to use them. An ERP system is no exception. When an ERP is integrated with cutting-edge applications like IoT, machine learning, advanced analytics, and artificial intelligence, training becomes critical. Having a well-trained, expert workforce lets companies take full advantage of their ERP. Taking the time and spending the money to train staff reduces problems and provides long-term profit gains.

Key Takeaways

Making these changes in your manufacturing ecosystem will help you maximize the benefits of your ERP system. They will also solidify your work standards and technical competencies.

  • The cost of installing a modern ERP system for manufacturers is countered by improving the return on investment.
  • Regardless of size, manufacturers should look at ERP software as an integral part of their production line. Training their workforce in how to use its many features will boost overall profits.

How choosing the right ERP system can boost your company's growth
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How choosing the right ERP system can boost your company’s growth
How choosing the right ERP system can boost your company’s growth 700 500 Xcelpros Team

Introduction

According to the latest Mckinsey research, agile organizations are healthier and more likely to meet long-term performance KPIs than their counterparts. Moreover, such organizations are more likely to achieve:

  • greater customer centricity,
  • faster time to market,
  • higher revenue growth,
  • lower costs, and
  • a more engaged workforce.

One way to improve the agility of your organization is to employ an ERP solution. Here we explore the advantages of utilizing an ERP system and outline five ways the right ERP system can improve agility and help you grow your business.

40%

of all companies won’t survive in the next ten years if they fail to figure out how to change and transform their business to accommodate the latest technologies.

Source: East Innovations

Benefits of Implementing an ERP Software Solution: Key Areas

Enterprise resource planning (ERP) as a business process management tool can enable organizations to manage day-to-day business activities like:

  • accounting,
  • procurement,
  • marketing,
  • human resources,
  • project management,
  • risk management,
  • compliance, and
  • supply chain operations.

The right Enterprise resource planning software application allows these different departments to communicate and share information with the rest of the company.

Figure: 1Different departments integrating through an ERP

Different departments integrating through an ERP

In other words, ERP software helps your business by making it easier for different departments to cooperate with just one interface.

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5 Ways a Modern ERP Can Help You Grow Your Business

Large ERP solutions often slip to the bottom of IT management’s agenda, but the growth benefits of ERP solutions—seamless, end-to-end integration across functions and business units—make them a fundamental asset for most large companies.

Moreover, the next generation of modern ERP solutions offers even more promising capabilities, both functionally and technologically. Below we explore just a few of the ways a modern ERP can help you grow your business.

Enhanced Insight and Visibility

ERP software provides complete access to important business processes by making data from different departments easily accessible to senior management. It provides a birds-eye-view of daily business operations like:

  • Financial Accounting
  • Management Accounting
  • Human Resources
  • Manufacturing
  • Order Processing
  • Supply Chain Management
  • Project Management
  • Customer Relationship Management (CRM), and
  • Data Services.

The boost in visibility enables decision-makers with the information they need to not only control daily operations but also improve inefficient processes and reveal opportunities for growth.

Better Reporting and Analytics

Accurate and complete reporting helps businesses plan, budget, forecast, and communicate the state of operations to the organization and other interested parties, such as investors and shareholders.

ERPs make big data and big business a good match because they enable your team with a single, unified reporting and analytics system for every process. You also enable your team to analyze and compare functions across departments, without the hassle of multiple spreadsheets and emails.

Greater Efficiency and Performance

By linking far-flung departments, ERP systems make it easier for your team to interoperate. The easier it is for your team to interoperate, the easier it will be for them to produce high quality work, and perform at their best.

“Higher the efficiency, the higher the profitability!”

Properly implemented, an ERP software suite can greatly reduce or eliminate repetitive manual processes, which frees up your team to focus on revenue-generating tasks. ERP systems can also aid in the adoption of industry best-practice, and alignment across the organization.

Stronger Data Security

ERP software improves data security by limiting input to a single system, thus eliminating the avenues by which a hacker could infiltrate the system and/or steal information. Both on-premise and cloud-based ERP systems provide a higher degree of security than the alternative, i.e., merging information from multiple systems.

Additionally, most ERP software runs on a single database system, which enables centralized backups of your critical and sensitive data.

Improved Supply Chain Management

The feature-rich working environment of an ERP suite provides a range of important supply chain advantages and play a key role in several aspects of the creation and maintenance of a superior supply chain management process, including:

  • Supply Chain Planning – ERP systems offer an easier and more flexible way to establish and alter the supply chain parameters.
  • Purchasing, Procurement and Execution – ERP software applications provide a more effective way to manage the procurement and supply of goods, services and other resources that are needed to operate a successful supply chain.
  • Monitoring and Maintenance – The ability to monitor, review and alter supply chain efforts and activities in real-time is essential for ensuring your business can maintain the flexibility needed to stay competitive and ensure cost-effective operations.
  • Measurement and Assessment – ERP systems offer superior information aggregation and organization, which makes it easier to identify and address undesirable variances throughout the supply chain.

How to Choose the Right ERP System

There is no one-size-fits-all ERP system for every business, but there are features that distinguish it from other types of business software, including:

  • Common database – Most ERP advantages stem from a common database that enables organizations to centralize information from numerous departments, and eliminate the need to manually merge separate databases.
  • Single user interface – ERP systems provide the same user interface (UI) and have a similar user experience (UX) across all departments and roles. In other words, everyone uses the same interface and sees the same thing when they interact with the software.
  • Process Integration – The right ERP system will enable your team to unify a diverse set of processes, and connect workflows that play crucial roles in the company’s success.
  • Automation – A basic feature of most ERP systems is the ability to automate repetitive tasks like manual data entry, which saves time, improves efficacy and minimizes human error.
  • Data Analytics – the most valuable aspect of an ERP is how it breaks down information silos, enabling your team to mix and match data from any part of your business into insightful reports.

Conclusion

The prospect of streamlined business functions and major boosts to productivity make ERP systems a good investment for any business owner. But which ERP system is right for your business? The answer to that question depends on your business.

Ultimately, the ERP system you choose for your business should not only make work easier, but also enable your team with the tools, time and information they need to improve business processes and set your company on a trajectory for growth.

latest trends in pharmaceutical manufacturing industry banner
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Latest Trends in Pharmaceutical Manufacturing Industry 2021
Latest Trends in Pharmaceutical Manufacturing Industry 2021 700 500 Xcelpros Team

By the Numbers

In a July 2021 report, Grand View Research estimated the 2020 global pharmaceutical manufacturing market value at $405.52 billion. Key metrics include:

  • 11.34%: The industry’s expected compound annual growth rate (CAGR) from 2021 – 2028
  • $957.59 billion: The revenue forecast for 2028
  • 77.95%: The retail segment market share in 2020

The IQVIA Institute for Human Data Science used a five-year estimate from 2018-2023 in its 2019 report. This report estimated spending on medicine to top $1.4 trillion by the end of 2021. Looking ahead to anticipated global medicine spending and growth in 2023 shows the top individual regions in terms of spending and 5-year CAGR as being:

  • United States: $625 – $655 billion, + 4% – 7%
  • Pharmerging: $355 – $385 billion, + 5% – 8%
  • Top 5 Europe: $195 – $225 billion, + 1% – 4%
  • Japan: $89 – $93 billion, – 3% – 0%

“Pharmerging” is a term given to emerging nations in areas such as Africa and parts of Asia.

Figure: 1Estimated medicine spending by companies in 2023

Estimated medicine spending by companies in 2023

Figure: 2Estimated growth rate of medicines by 2023

Estimated growth rate of medicines by 2023

5 Topics to Ponder

Despite all the problems and deaths caused by Covid-19, along with its impact on pharmaceutical manufacturing and the U.S. trade war with China, the market for medicines and related products is staying strong.

Looking several years out, one question CEOs and CFOs must ponder is what changes can we make now to prepare for a profitable future?

According to The Medical Futurist, the Top 5 trends for leaders to consider in the coming years include:

  1. 1.Using artificial intelligence to speed research & development. Spending on AI in healthcare alone is expected to hit $31.3 billion by 2025.
  2. 2.Empowering patients to aid in drug design and advisory boards. TMF notes the Food and Drug Administration has its own patient engagement advisory committee. The FDA states the committee considers different topics including the design of clinical investigations, communicating device benefits and risks, digital health technology and more.
  3. 3.Conducting experiments using computer simulations or “in silico,”. This is another digital trend in pharmaceutical manufacturing. This method eliminates animal testing and side effects on humans and animals. So far, this technology is less than halfway to becoming a reality, though.
  4. 4.Boosting the supply chain with technology such as blockchain to enhance security and improve inventory tracking. “Counterfeit drugs might make a cheaper alternative but are the cause of tens of thousands of deaths worldwide while the fake drug trade continues to be a profitable multi-billion dollar business,” according to TMF.
  5. 5.Using technology to appeal to more providers and payers. TMF mentions a wearable monitoring device and an app for feedback from doctors plus the app itself. Another technology is 3D printed pills such as Spritam that gained FDA approval in 2015.

Another topic mentioned in a different report is using real-world-evidence (RWE). A 2018 report by Deloitte defines RWE as, “clinical evidence about a product’s usage, potential benefits and risks derived from real-world data.”

However, Deloitte’s survey also highlighted three potential barriers to RWE adoption by pharmaceutical companies:

  • 75 percent: Major lack of receptivity by external stakeholders
  • 70 percent: Lack of understanding by internal stakeholders
  • 65 percent: Lack of access to necessary external data

AI and ERPs

Enterprise Resource Planning (ERP) software such as Microsoft Dynamics 365 Finance can support different AI modules, as needed. Depending on a business’ requirements, AI can help conduct research more efficiently, automate manual processes and perform other repetitive tasks.

AI benefits researchers through natural language processing and reasoning, learning from data and optimization addressing problems. One example cited by the Royal Society is using “deep” neural networks to identify features required to solve problems. Another uses reinforcement learning to examine many scenarios and assigning credit to different moves—such as chemical combinations—based on performance.

When it comes to research and manufacturing of pharmaceutical products, AI helps researchers use genomic data to predict protein structures, improving diagnosis and developing new treatments. Using machine learning—one part of AI—to predict the three-dimensional structure of proteins from DNA sequences is another example. This is quickly becoming one of the biggest trends in the pharmaceutical industry in 2021.

By creating a highly-detailed computer model that replicates a human organ, pharma companies can see the effectiveness of different drug therapies on specific diseases.

When it comes to pharmaceutical manufacturing technology, which versions work? What are the side effects? What changes can we make to reduce the side effect’s severity? These are some of the questions AI can help answer quickly and efficiently without experimenting on humans or animals.

In terms of business, “artificial intelligence technology allows businesses to automate a variety of processes, frees up employees’ time and helps improve productivity.” The result is greater output in less time at lower cost, according to Intellspot.

AI also helps capture competitive research and analysis. One tool with that capability is Microsoft Power Bi. This software has three types of AI transformations:

  • Text analytics tags images and extracts key phrases
  • Vision analyzes images
  • Azure ML helps generate insights and predictions

ERPs and Regulatory Compliance

A major obstacle unique to technology in pharmaceutical manufacturing is dealing with FDA regulations. Many of these rules require strict recordkeeping. Modern ERPs, which share data between departments, allow companies to keep more accurate documentation and inventory. ERPs allow executives to review data for accuracy, ensuring that information from Inventory Control matches what Finance says it should report.

A key feature of sharing information between different departments such as Inventory Control and Finance, companies can spot areas for improvement. Are FDA documentation requirements being met? A simple query can give a CEO the answer for any department anywhere in the world.

ERPs can also ensure that product communications meet the FDA’s stringent requirements for truth under the Federal Food, Drug and Cosmetic Act (FD&C Act). These laws can result in severe fines for conveying important information the FDA considers misleading.

Labelling is another major part of FDA rules, one where D365’s Inventory Control Module for Dynamics Supply Chain Management stands out. This lets businesses generate barcodes and other labels, tracking products and batches from the moment they arrive through production to their delivery to customers.

Summary

Pharmaceutical manufacturing technology, like the use of AI or ML in research & development, are quickly becoming leading pharmaceutical industry trends since 2020, helping make pharmaceutical companies leaner and more efficient. Modern software like tier 1 ERPs lets them gather, sort and analyze information obtained from the continuous manufacturing of pharmaceuticals much more rapidly than ever before.

Keep up with the Pharmaceutical Manufacturing trends. Get an obligation trial of Microsoft ERP tailored for the Pharma Industry.

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ERP and Big Data
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ERPs Make Big Data and Big Business a Good Match
ERPs Make Big Data and Big Business a Good Match 700 500 Xcelpros Team

Introduction

What does “Big Data” mean to you and your company? To many, the phrase means large quantities of information from different sources, data that changes by the second. For example, it can refer to the temperature of a chemical process where a small variation makes the difference between good product and wasted materials.

A common big data definition is, “a collection of data that is huge in volume yet growing exponentially with time,” guru99.com states. The “4 Vs of Big Data” are:

Figure: 14 Vs of Big Data

4 V's of BigData

  • Volume, in terms of data coming from multiple sources at the same time
  • Variety, which can be flow volumes, temperatures, production costs and other information calculated separately
  • Velocity, referring to the speed of information from application logs and device sensors (IoT)
  • Variability, data flows when a machine is running and stops when the production cycle ends

“Big Data” can also refer to lines from sales contracts referencing products, volumes and/or quantities from several customers. From a supply chain perspective, those same sales numbers require raw materials plus labor and machine operating time to produce them.

In the past, “Big Data” often referred to information from one department such as Production or Sales. One of the biggest challenges with big data is providing information siloed in one department to other areas that need it.

There are even challenges to searching big data, which includes getting results based on the query. When the query isn’t phrased correctly, or a required document has a naming error, important information is left out.

A key challenge is overwhelming volume.

  • The New York Stock Exchange generates one terabyte of data each day
  • Facebook cranks out more than 500 terabytes of customer-uploaded photos and videos every day
  • A jet engine generates more than 10 terabytes of data in 30 minutes of flight

By the Numbers

Many businesses are drowning in data, not all of which is useful.

  • 8%: the number of businesses using more than 25% of internet of things (IoT) data available to them
  • 10% – 25%: Marketing databases containing critical errors
  • 20% – 30%: Operational expenses directly tied to poor data
  • 40%: The growth rate of corporate data with a study by SiriusDecisions finding organizational data typically doubles every 12-18 months
  • 40%: the number of businesses missing business objectives because of poor data quality
  • $13.3 million: The average annual cost of poor data quality

Big Data Costs

Big Data comes with costs, especially for in-house networks. Once data is obtained, it gets stored before being analyzed. Data is usually backed-up in case something happens to damage, destroy or in the case of hacking, hijack it.

The actual costs of this data varies based on business size and need. Estimates place the lowest range at $100 – $200 per month to rent a small business server. Installation costs typically start at $3,000 and go up from there.

Big Data includes up-front as well as hidden costs. Up-front costs most people see consider includes:

  • Software tools to manage and analyze data
  • Servers and storage drives to hold the data
  • Staff time to ensure the physical devices work properly and to manage the data

These costs scale proportionally depending on the business’ storage and retrieval requirements and the processing power required to gather the data.

Hidden costs usually refer to the bandwidth needed to move data from one source or site to another. While we might consider it a simple task to download a movie on a cellphone, moving terabytes of data between servers can be significantly more expensive.

Accurately estimating big data costs is basically impossible without a detailed look at each company’s specific requirements and needs. However, online research estimates them to be anywhere from several hundred dollars per month for a small business to tens of thousands of dollars per month or more. Infrastructure costs alone can easily top $1,000 – $2,000 per terabyte (TB) with qualified outsourced consultant pricing averaging between $81 – $100 per hour.

Big Data Limitations

Having access to large volumes of data is great – when a company knows what to do with it. Especially when servers are in-house, big data has its limitations. These problems include:

  • Software tool compatibility, such as different types and brands of databases
  • Correlation errors, such as linking incompatible or unrelatable variables
  • Security and privacy from the standpoint of only exposing your data to the eyes of qualified people

From a mechanical perspective, one industrial device might use a Siemens programmable logic controller (PLC). Another device can use a Rockwell PLC and a third could be from Mitsubishi Electric. These different devices add additional layers of complexity.

Using supervisory control and data acquisition (SCADA) architecture is one way some larger companies are resolving PLC compatibility issues. SCADA includes computers, networked data communications and graphical user interfaces.

Figure: 2Big Data Limitations

Big Data Limitations

Resolving Big Data Issues

One way pharmaceutical companies can resolve rising big data issues, especially those caused by using older, legacy systems is with a modern ERP. Enterprise resource planning software such as Microsoft Dynamics 365 (D365) resolves many of these incompatibility issues.

Data integration is a major big data problem for companies that use one database in production and another in finance.

D365’s data integrator is a point-to-point integration service used to integrate data. It supports integrating data between Finance and Operations apps and Microsoft Dataverse. The software lets administrators securely create data flows from sources to destinations. Data can also be transformed before being imported.

Dual-write—a related D365 function—provides bi-direction data flow between documents, masters and reference data.

This type of data collection raises potential ethical issues when accessing large quantities of personal information, which could include contact information for patients enrolled in a new drug study.

Installations by professionals experienced in working with pharmaceutical companies can organize data and help strip out personal information. Removing it reduces the chance of a HIPAA (health insurance portability and accountability act) violation.

Being a cloud-based product, D365 also cuts down many of the personnel costs associated with big data management and maintenance. Microsoft assumes those costs along with the burden of data security.

Conclusion

Having a lot of information lets companies make accurate, informed decisions. Problems crop up when data is kept in departmental silos. Using an ERP to integrate information across departments removes many barriers to sharing information, which leads to more accurate sales and inventory predictions, reducing overall costs and boosting profits.

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ERP For Small Business
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A Beginner’s Guide to ERP Systems for Small Business
A Beginner’s Guide to ERP Systems for Small Business 700 500 Xcelpros Team

Introduction

Enterprise resource planning (ERP) software can help any small to medium enterprise (SME) flourish and grow.

Six key benefits of using integrated ERP in a small business are:

  • Sharing information between different business processes such as inventory management and finance.
  • Enhancing productivity through using a single database accessible to all relevant departments.
  • Improving control and reducing operating costs by reducing data entry errors.
  • Greater flexibility, allowing the company to rapidly adapt to changing conditions such as supply chain disruptions brought on by new Covid-19 restrictions.
  • Boosting sales through tighter inventory control.
  • Enhancing data security when using cloud-based products such as Microsoft Dynamics 365 (D365).

Figure: 1ERP Software for Small Business 6 Key Benefits

Benefits Of ERP software for small business

Upsides and Downsides to an ERP

Updating a small business to a modular cloud-based ERP program like D365 has its drawbacks. They include:

  • Resistance from executives, managers and workers. They don’t understand why they can’t keep using the same old spreadsheets the same old way. ERPs are much more efficient.
  • Cost of licensing and installation, which is generally done with the help of the right ERP consultants. Costs are recovered through increases in efficiency. The ability to respond quickly to customer requests generates more sales.
  • Possible on-site computer upgrades as the primary servers migrate to the cloud. High speed internet connections permit real-time viewing of data regardless of location.
  • A potential reduction in productivity while the new system gets online and the staff adapts to the new ERP. Eventually, users get to the point that small errors like typos or duplicate data entries disappear entirely, further boosting productivity.

These drawbacks are easily offset by an ERP’s inherent advantages, especially when using a modular system like D365. Additional functionality can be added as the business requires. Each module can also be expanded, adding more users and increasing capabilities such as storage.

Among the factors to consider when choosing an ERP system are the willingness of different departments to share data, and more importantly, contribute to eliminating any disintegrated processes. Finance will know what sales has in the works. Sales will know what raw materials Inventory has on-hand. Production will know when the next big order is coming up. Departments need to move beyond the “what’s mine is mine and no one else’s” mentality. A unified ERP such as D365 allows companies to do just that.

For example, sharing access to data means managers and executives have the ability to spot and correct errors quickly. They can also keep tabs on what every connected department is doing. An example is having inventory, production, finance and sales working together ensuring a project is delivered on time and on budget.

Another advantage of using an ERP in a small business is scalability in terms of:

  • Expanding existing facilities
  • Adding potential new suppliers
  • Increasing the size of projects
  • Increasing product lines

Inventory Control or Finance?

Two of the most visible and valuable D365 ERP modules are Supply Chain Management and Finance. Both are appropriate for small and medium businesses updating their systems. Which one to install first depends on the company’s current and future needs.

D365 Finance lets companies of any size, “Assess the health of your business, improve financial controls, and make timely decisions to drive agility and growth using comprehensive, real-time financial reporting, embedded analytics, and AI-driven insights,” Microsoft states.

For example, the artificial intelligence built into the software lets SMBs do a better job of managing business applications. Key elements include:

  • Accurately determine project cash flow
  • Predict customer payments
  • Rapidly provide budget proposals
  • Simplify financial management
  • Automate vendor invoice processing
  • Manage credit risks and collections
  • Provide a unified information source

When the company’s major issue is a lack of accurate inventory management, such as small business manufacturing, then D365’s Supply Chain Management module makes sense as one of the first modules.

One of Supply Chain Management’s critical functions is its ability to improve product deliveries. Functionality like creating barcode labels enhance a business’ ability to track supplies. Labels coupled with hand-held scanners or cellphones indicate where raw materials are in terms of their physical location. They also indicate where they are in the production cycle. Tracking continues from the time items arrive at the warehouse to when they are delivered as finished products.

Tracking incoming and outgoing ships is also a key reason to invest in the Supply Chain Management module. In a world beset by an ongoing pandemic, it’s important to know that raw materials will continue flowing. Last minute delays can make or break a company’s production schedule.

When the Supply Chain Management module ERP is used in small business manufacturing, companies are able to more accurately schedule certain production tasks. This leads to overall equipment effectiveness (OEE) being maximized.

When combined with internal Internet of Things (IoT) sensors, production machines can provide a continuous stream of wear data. Instead of shutting down a production line while waiting for a replacement part to arrive, the part can be ordered in advance so it is on-hand when needed. Production delays are reduced while active working time increases.

The Supply Chain Management module also helps provide advanced knowledge of potential quality control issues before they occur. Instead of wasting raw materials and worker time making deficient products, information from the Supply Chain Management module helps managers know when to stop production and resolve the issue. This boosts efficiency by maximizing raw material use.

Supply Chain Management and Finance are two of the D365 modules. Other Microsoft products cover Sales, Marketing, and the overarching Business Central (ideal for a company that is small)

Data Security

Another issue plaguing businesses worldwide is industrial espionage, also known as data theft. Private and some state-sponsored actors gain access to a company’s data and then threaten to destroy or corrupt it unless a ransom is paid. Even then, proprietary formulas and patent information may be sold to an unscrupulous competitor.

Some small businesses lack the resources to prevent every potential data theft attempt. Using a cloud based ERP like D365 for small business means you have Microsoft’s massive team protecting your data in distributed server farms. Data is safely stored away from company property that can be damaged or destroyed by a fire, flood, hurricane or earthquake.

Information as a Product

Today’s businesses buy, sell and use one main product, regardless of industry: information.

ERPs store information in a central repository, available to anyone with the right access. Older programs tend to silo data: Sales has its data. Finance has its numbers. Inventory has its own database. None of them share what they know effectively or efficiently.

ERP systems configured for a small business let it use its information much more efficiently. Data produced in the factory is immediately viewable by Inventory, allowing that department to order just enough materials to meet expected demands. When potential supply chain disruptions are forecast, Inventory and Finance working together, can quickly determine the best way to minimize impacts on production.

This allows small business’ funds to be used more wisely, allowing the company to make wiser investments as they continue to grow.

Final Thoughts

Modern ERPs like Microsoft Dynamics 365 can help small businesses grow by efficiently using data it produces on a daily basis, and helping remove artificial barriers and data silos, allowing information to flow freely to all departments of a company. Help with selecting the right ERP is best achieved with a team that understands your industry, and supports the best products along with the experience to implement them.

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ERP in Inventory Management
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The role of an ERP system in Inventory Management
The role of an ERP system in Inventory Management 700 500 Xcelpros Team

Introduction

A previous article on enterprise resource planning software (ERP) mentioned the benefits of artificial intelligence (AI) and machine learning (ML) in business software. This article covers how Inventory Management functions as part of an ERP.

The common purpose of any ERPs is to integrate, centralize and streamline all business operations. The most common ERP inventory management functions are:

  • Supply Chain Management including tracking and managing raw materials, work-in-progress and finished products
  • Integration with logistics, shipping and B2B ecommerce
  • Managing procurement and sales orders
  • Distributing orders across channels
  • Warehouse management and stock transfers using serialization
  • Integration with Payment gateway
  • Managing accounts
  • Dashboarding and report generation using analytics
  • Quality Management
  • Demand forecasting using AI and ML

Executive Summary

  • ERPs have a broad range of application areas. Inventory management is the most sought out functionality (67%) among users after Accounting (89%).
  • Inventory management helps companies organize and plan their production strategy, along with maintaining ideal stock levels.
  • Effectively managing inventory promotes more efficient use of precious working capital, helping to maintain optimal stock frees working capital and prevents losses due to stock-out.
  • The average manufacturer has 10% – 20% of its revenue committed to inventories. Reducing inventory by 20% – 25% can cut the revenue impact by 2%- 5%. For a $6 billion company, that inventory reduction frees an estimated $200 – 500 million in working capital.

ERPs perform many inventory management functions, supporting the entire supply chain from order and storage of raw materials to final delivery.

Today, the importance of inventory management has continued to evolve. It no longer deals only with keeping track of what’s currently in the supply, production and delivery pipelines. It also has a significant effect on business strategy.

ERPs are now equipped with artificial intelligence and machine learning. These additions transform a tool first appearing in the late 1990’s into an invaluable piece of technology. For example, using historical data, a modern ERP can more accurately predict future demands and current inventory levels.

All businesses are realizing the benefits of going digital. Traditional companies that once shied away from adopting technology are now embracing it.

Connecting businesses, such as a pharmaceutical manufacturer with its internal and external suppliers, generates massive amounts of data. ERPs help chief executive officers and other leaders make sense of the numbers. The software lets leaders compare historical behavior with current trends, making accurate inventory predictions. ERPs can reveal important insights by leveraging data across business functions.

Benefits of ERP In Inventory Management

A SelectHub survey found that Inventory Management (67%) was the most used part of a modular ERP package after accounting (89%).

Figure: 1A 2018 Survey by Select Hub Found That The Most Important Function in an ERP was Inventory Management

Inventory Management functionalities

Functions of ERPs in Inventory Handling

ERPs perform six primary inventory related functions. These include:

  1. 1.Better forecasting accuracy
  2. 2.Segmenting, clustering and classifying materials
  3. 3.Making warehouses more intelligent
  4. 4.Permit accurate, timely inventory planning
  5. 5.Reduce waste
  6. 6.Manage returns and order cancellations

Improving Inventory Accuracy: Some modern ERPs like Microsoft’s Dynamics 365 Finance come with many built-in AI and ML capabilities. This functionality lets executives review sales data, seasonal demand and other information to predict inventory needs. By comparing historical and current data, companies can devise a robust plan to increase or decrease inventory and storage capacity suiting anticipated market conditions. D365 Finance also accepts variables for greater accuracy.

Key benefits include:

  • Artificial intelligence helps predict future demand using historical data
  • Comprehensive inventory planning translates to higher customer serviceability, boosting customer satisfaction

Segmenting, clustering and classifying materials

Isolated data is only valuable to that portion of the business. To help the entire business and provide insights, data must be visible to other departments. Using an ERP’s Inventory Management module lets companies tag, cluster and analyze each item or stock keeping unit (SKU). It produces labels that can be read by mobile phones and other portable devices, providing access to a wealth of information while tracking every item. Classification options include:

  • Units of measurement
  • Product usage
  • Material source
  • Alternatives or substitutes
  • Allocation
  • Cost and price
  • Demand
  • Supplier or vendor

Classifying inventory items lets users analyze each item based on the business needs, and prioritize the ones that are most critical.

Making Warehouses More Intelligent

When products are given machine-readable barcodes or QR code labels, companies can track material movement in real-time.

Modern ERP lets warehouse managers create an operative warehouse plan with access controls at every level. This is particularly crucial for manufacturers with multiple production sites. Setting access controls ensures the right people can move inventory items at the right time.

ERPs allow warehouse managers to efficiently allocate more space to the items that need it and reduce space from those that do not.

Combining the functionality of an ERP with robots and other forms of automation reduces human efforts. For example, beverage giant Coca-Cola uses AI to count the varieties and volume of bottles stored in cabinets or display units by analyzing a photograph clicked on a mobile device.

Other benefits of an efficient warehousing plan include:

  • Tracking each stage of a product from raw material to work-in-progress and finished goods
  • Preparing accounts for stock transfer
  • Reducing human effort in mundane tasks, such as manually counting inventories, letting workers perform more valuable jobs
  • Maintaining ledgers of opening and closing stock balances
  • Reducing dead stock by efficiently managing expiring inventory

Permit Accurate and Timely Inventory Planning

An ERP system ensures companies maintain ideal stock levels, permitting more efficient use of working capital.

Today’s ERPs come with features that help with material requirements planning (MRP). This includes production scheduling, setting up reorder-levels and establishing inventory minimum and maximum levels. The business application tool records lead times related to purchases of raw materials, manufacturing time, quality checking, packaging, logistics and other functions. All of this data combined helps the planning engine create better forecasts.

Reducing Waste

The combined benefits of classifying items and inventory planning helps reduce waste. The inventory management module of an ERP provides complete visibility of all inventories, including clusters and substitute products. Module users can also sort inventories by batch numbers or serial numbers.

When a particular product has an unanticipated surge in demand, companies can easily identify substitute products in an attempt to reduce lost sales. Aligning substitute and primary products lets customers looking for affordable alternatives or shorter lead times find workable options, further boosting revenue.

Waste reduction benefits of an ERP include:

  • Offering alternative or substitute products when primary product levels are low.
  • Provides options for price sensitive customers, increasing customer loyalty.
  • Uses attributes assigned to each SKU to make it easy to locate substitute products.

Managing returns and order cancelations

ERPs manage returns with greater ease than older methods. ERPs reconcile sales credit memos and accounting letting companies issue refunds or shipping fresh products.

Return benefits include:

  • Easier tracking of refunds and reshipments.
  • Quicker return decisions by providing a complete view of sales, current inventories, cash balances, shipping availability and other issues.
  • Automatically calculates foreign exchange rates.

Conclusion

The primary benefit of an ERP system is the ability to track inventory, reduce stocking costs and maximize working capital accurately and efficiently. This significantly reduces administrative and operational costs without sacrificing functionality.

Organizations looking to optimize inventory planning and become more competitive must implement a modern ERP system. The cost of implementing a modern ERP is easily made back in overall savings with included inventory controls that are more accurate, reduce waste, and produce happier customers with much greater flexibility.

Book a assessment on how to use an ERP in Inventory Management to improve efficiency.

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References: ERP buying trends

Advantages of Using an ERP System to Ensure Regulatory Approval
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Advantages of Using an ERP System to Ensure Regulatory Approval
Advantages of Using an ERP System to Ensure Regulatory Approval 700 500 Xcelpros Team

Introduction

Employing the right enterprise resource planning (ERP) system can help pharmaceutical companies gain regulatory approval of drugs and other new products faster and with fewer requests for missing information.

“One of the benefits of enterprise management systems is that much of the data these regulations require can be collected through automated means. Thus, enterprise systems can be used to ensure compliance with increasingly onerous federal regulations without taking personnel away from their essential customer service functions,” the University of Scranton states.

Other advantages of an ERP system include:

  • Real-time data access
  • Standardizing business processes
  • Secure data
  • Usable and shareable data

The FDA Approval Process

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is the agency responsible for ensuring new drugs follow the regulatory approval process. CDER does not test drugs but its Office of Testing and Research performs limited drug quality, safety and effectiveness research.

CDER physicians, chemists, pharmacologists, statisticians and others review every piece of new drug application (NDA) data. This includes labeling, which follows specific FDA formatting and requirements.

The FDA currently has 12 approval steps that follow preliminary drug development. ERPs are designed to ensure pharmaceutical companies keep accurate track of every step from the purchase of raw materials to the labeling of individual samples.

Figure: 1FDA’s Lengthy Drug Approval Process in Twelve Steps

Regulatory Compliances

Gaining FDA Approval

Pharmaceutical manufacturers can easily invest years and years, and vast amounts of money developing a new drug therapy.

The regulatory approval process itself can take 6 to 10 months depending on how many benefits the medication provides. Changes to the FDA Standard Review process in 2002 defined a 10-month goal to look at drugs offering minor improvements over existing marketed therapies.

The FDA also offers Priority Reviews with the goal of completing them in six months. These reviews are applied to drugs offering treatments where none currently exist. Priority Reviews are also given to medications that offer major advancements in treatment.

Using the most recent update to the Prescription Drug User Fee Act (PDUFA)—the sixth version—the FDA uses collected fees to hire more reviewers and support staff.

These fees are not cheap. In fact, according to the FDA, the 2021 application fee with required clinical data is $2,875,842, a change of -2.3% over 2020 ($2,942,965). The FDA can also issue additional invoices for program fees not previously invoiced.

User Fee 2020 2021 Change
Application Fee: Clinical Data Required $2,942,965 $2,875,842 -2.3%
Application Fee: No Clinical Data Required $1,471,483 $1,437,921 -2.3%
Program Fee $325,424 $336,432 +3.07%
Source: FDA

Regulatory Audits

The FDA inspects and assesses regulated facilities during a regulatory audit. Some of the audit information is released to improve the public’s understanding of how the agency protects public health, its website states.

According to the FDA, “Disclosure of a firm’s inspection information encourages firm compliance and provides the public with an understanding of the Agency’s enforcement actions and an ability to make more informed marketplace decisions… Laboratory records and logs represent a vital source of information that allows a complete overview of the technical ability of the staff and of overall quality control procedures.”

The FDA has 10 detailed inspection guides related to drugs alone. For example, the guide for pharmaceutical quality control labs has 21 sections, which includes laboratory management.

The Role of ERP Systems in Regulatory Compliance

The Microsoft Dynamics 365 ERP platform seamlessly gathers data from different teams and stores it on Microsoft Cloud Servers. Researchers can review records during the development phase. Easy access to earlier successes and failures ensures work is not duplicated, increasing efficiency. Microsoft 365 has the ability to let information technology (IT) administrators apply labels to different documents. These labels let companies classify and protect sensitive data—like formulas—allowing access only to qualified, approved users. Sensitivity labels also apply content markings that can encrypt data, preventing it from being viewed by competitors and outside sources. Pharmaceutical companies can control who is able to view this data and for how long.

Regulators are allowed to see only the data they need, not private, confidential materials.

During the Investigational New Drug (IND) phase, the sponsor submits an application containing the drug’s composition and manufacturing and an outline of the human trials. Among the documents being reviewed in this stage are those related to informed consent and human subject protection.

The ERP Regulatory Advantage

ERP software has several advantages over using spreadsheets and external databases when dealing with regulatory compliance.

A key element is tracking the supply chain from ordering raw materials to delivering finished products to customers. Microsoft Dynamics 365 Supply Chain Management is an example of an ERP product that uses a single, secure, cloud-based database to eliminate duplicate spreadsheet entries and transposed numbers. Additional key compliance benefits of using the right ERP include:

  • Visibility and transparency: ERPs have lot and serial number traceability, tracking material flow. This is a common compliance requirement.
  • Audit trails: This is included in D365, allowing administrators to know who accessed the system and when, what actions—including file deletions—were taken and where updates originated. Auditing can be enabled or disabled for an entity or specific fields within an entity.
  • Data access and security controls: these are built into Dynamics 365 products as mentioned earlier.
  • Encryption: Transactional data is securely stored and automatically encrypted when accessed by authorized individuals.
  • Electronic signatures: Secures transactions by confirming the operator is authorized while also creating a transaction summary and log.
  • Record Retention: D365 allows this to be set through the Privacy settings and elsewhere. For example, D365 Finance automatically saves attached documents for 180 days. That number can be adjusted through the document management parameters > General > History > Enable document history settings
  • Inspection Controls: D365 allows companies to store and track test evidence, ensuring materials meet quality control standards.
  • Document Controls: Tracks and manages formulas, engineering specifications, material specifications, operating procedures and other document types.

Summary

Getting a drug approved by the FDA is a time-consuming, expensive proposition. The cost of regulatory approval for pharmaceutical products can easily exceed $3 million in government fees alone.

The right ERP can help companies track materials throughout the supply chain and product development. This enhanced tracking and secure data storage reduces the efforts required to navigate the drug approval process.

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