The Business Analytics Challenge

Companies in the life science and FDA regulated industry often treat each compliance requirement as a separate management program. This could be a clinical trial reporting operation, manufacturing lot tracking, or one of many other requirements. Programs such as these tend to thrive in the industry. Each program develops their own approach to gathering data to report to regulatory authorities, however, this may increase the risk for additional compliance costs and potential mistakes. Life science firms can now build an approach to standardize compliance by building it into their business processes.

Which functions are needed to help you meet regulatory requirements and uphold quality and safety throughout your operations?

The past year has seen some particularly egregious recalls, including repeated outbreaks of E. coli, salmonella and hepatitis A. High-profile recalls such as the one involving romaine lettuce have impacted consumers’ trust, and regulators are doubling down to ensure such oversights do not occur again in the future. Likewise, food and beverage manufacturers are revisiting their sourcing and materials handling procedures to close any quality-related gaps in their practices.

Manufacturing’s digital transformation is the new place for the evolving role of ERP. From business analytics to artificial intelligence and the Internet of things (IoT), new technology is disrupting how manufacturers do business. One of the most time-consuming tasks, that requires a high level of expertise, has always been taking the raw operational data and turning it into actionable insights. If this analysis is done in house, your only option was to purchase an expensive business intelligence software separately and then, if possible, integrate with your ERP system.

ERP is playing a significant role in manufacturing’s digital transformation. From business analytics to artificial intelligence and the Internet of things (IoT), innovative technology is disrupting how manufacturers do business. Advanced technologies have affected the competition within the manufacturing industry both domestically and abroad. Manufacturers must continuously analyze how they do business to remain competitive. ERP systems have become critical to making operational improvements in the modern age.

Thanks to ERP software, we expect to see a number of trends take hold over the next year.

From operational efficiency to recall preparedness, a strong traceability system is critical to remaining competitive in today’s food and beverage market.

Traceability, or the ability to trace the flow of food and beverage products through production, has always been essential to operational efficiency. But in the age of mounting global competition and increasing regulatory oversight, it is more important than ever.
Today’s food supply chain has expanded, such that it is common for the production process to span continents. Given this added complexity, even small and mid-sized manufacturers must invest in the proper technologies to ensure traceability, both as a means of food safety and of remaining nimble in a competitive market.

In this blog, we review how ERP supports traceability and the must-have features to look for in your food and beverage ERP solution.

From business analytics to artificial intelligence and the Internet of things (IoT), ERP’s new place at the heart of Manufacturing’s digital transformation as the cutting-edge technology is disrupting how manufacturers do business.

What is blockchain? You have probably heard of its most famous application, Bitcoin, which is a blockchain-based currency system. It is actually the first digital currency system to work without a central bank or common administrator. Since its creation, it has been known as “the people’s currency,” and relies upon the unique security of blockchain technology to remain fully democratic in function.

Blockchain’s powerful technology has potential implications for next-generation ERP. Let’s discuss how it might be used within the world of manufacturing.

From business analytics to artificial intelligence and the Internet of things (IoT), learn about the cutting-edge technologies disrupting how manufacturers do business. In this special blog series regarding Digital Transformation & the Evolving Role of ERP, we will discuss ERP’s new place at the heart of manufacturing’s digital transformation.When we look back at of the mind-boggling depictions of the future in books and movies, we can, in some cases, now say those predictions were not so far-fetched. 

Thanks to emerging artificial intelligence (AI) technologies, many of the “futuristic” portrayals are now reality. Robots can understand and speak natural language and “digital assistants” are ready to provide instant answers to our questions.

As noted in the Boston Business Journal’s April 4 article ("Biotech, in motion: Demand for life science execs fuels game of musical chairs"), while funding has been handily secured by many Boston biotech firms, qualified people to fill recent job openings have been more elusive. The challenge to recruit and retain life sciences talent has led to extended vacancies and instability in organizations otherwise poised for growth.

For biotech companies struggling with an incomplete workforce, now is the time to explore how technology could empower organizations to scale in spite of staffing challenges.

Learn about the advantages of using an ERP Software in an FDA-regulated industry. In this blog series, we will discuss issues ranging from organizing mission-critical documents to vendor management, as well as how an ERP system can help keep manufacturers in compliance and product timelines in place.

Manufacturing executives in FDA-regulated industries used to spend hours at their desks with stacks of papers awaiting their signatures. This practice can now be a thing of the past. Since executives are no longer sitting behind a desk daily, and the periodic approvals have now multiplied in frequency, eSignatures are a critical component of successfully doing business in a regulated industry.  

Learn about the three areas where an ERP system can support compliant supplier management. In an FDA-regulated industry, it’s not uncommon to utilize suppliers for components of their finished products.

As not all parts may be produced on site, the weight of compliance – and, ultimately, product quality – belongs to the company receiving the product or service.  The selection, approval and ongoing evaluation of suppliers is heavily regulated and a critical responsibility for manufacturers.

In this blog series, we are looking at the role of ERP in the digital transformation initiatives for today’s manufacturer.

Not that long ago, ERP was an extremely cumbersome software, used only by those organizations that had the personnel and capital to integrate the solution into their operations. Today, it’s fair to say that ERP has become mainstream. In fact, it is considered by many manufacturers to be the key technology for their overall operations. Last year, we took a look ahead at how ERP would factor into digital transformation. Let’s look back at our predictions and see how we did.

In this special blog series, ERP Software & FDA Validation, we’ll discuss the advantages of using an ERP system in an FDA-regulated industry. From organizing mission-critical documents to vendor management, you’ll learn how ERP helps keep product timelines in place and manufacturers in compliance.

From managing suppliers to delivering on your customer’s expectations, quality is a responsibility that is fulfilled by everyone at your organization, whether they realize it or not.

The Copley Consulting Group is proud to have been named a top CRN Tech Elite 250 company, having earned the highest number of advanced technical certifications from leading IT vendors. Copley Consulting has a commitment to building and maintaining the technical skills needed to provide our customers with the highest level of service across the Infor and Qlik ecosystems. We are honored to accept this award and will continue to improve our skill sets and vendor certifications to meet our clients' demands.

In this blog series, ERP Software & FDA Validation, we’ll discuss the advantages of using an ERP system in an FDA-regulated industry. From organizing mission-critical documents to vendor management, you’ll learn how ERP helps keep product timelines in place and manufacturers in compliance.

From food and beverage to medical device, manufacturers in FDA-regulated industries have a responsibility to maintain end-to-end lot and serial number tracking and management of inventory.

The development of a medical device can take years and cost tens of thousands of dollars in research and development. During this time, documented information around the development is accumulated. From quality documentation and design data to computer-aided design (CAD) files and part specs, the device master record (DMR) and design history file (DHF) are critical in the medical device life cycle. The proper maintenance of these files is essential to not only FDA compliance but also operational success. Here are three ways an ERP system helps overcome common challenges in DMR and DHR management.

In this special blog series, we will review the disruptive technologies being introducing by today’s forward-thinking manufacturers. Over the next few weeks, you’ll learn about the cutting-edge tools transforming the industry and the ways ERP can support their implementation.

Imagine a future where you don’t need to own a car. You can simply hail a ride – in a self-driving car, also known as an autonomous vehicle (AV) – outside your doorstep. Your pocketbook – and the economy at large – would look a lot different. Our roads and our environment would be transformed.

In this special blog series, we will review the disruptive technologies being introducing by today’s forward-thinking manufacturers. Over the next few weeks, you’ll learn about the cutting-edge tools transforming the industry and the ways ERP can support their implementation.

Initially, you might consider 3D printing to be a threat to manufacturers. After all, in the hands of consumers, a 3D printer can make any individual an amateur manufacturer, or “maker.” But in the hands of an expert manufacturing company, 3D printing is introducing new levels of efficiency – for both time and materials – while fostering innovation in R&D. Here’s how forward-thinking manufacturers are leveraging 3D printing to their advantage.  

In this special blog series, we will review the disruptive technologies being introducing by today’s forward-thinking manufacturers. Over the next few weeks, you’ll learn about the cutting-edge tools transforming the industry and the ways ERP can support their implementation.

In this special blog series, we will review the disruptive technologies being introducing by today’s forward-thinking manufacturers. Over the next few weeks, you’ll learn about the cutting-edge tools transforming the industry and the ways ERP can support their implementation.

The monotonous, the laborious, the dangerous. The range of manufacturing tasks being handled by today’s robots may surprise you. With digital transformation becoming a norm around the globe, the pressure to automate is stronger than ever before, and manufacturers are increasingly turning to robotics to help them streamline processes and lower costs – all while boosting productivity, satisfying customer demand and pursuing continuous innovation. So, how exactly are manufacturers employing robots to achieve these lofty goals?

From predictive analytics to instant decision-making, artificial intelligence (AI) is enabling progressive manufacturers to transform how they do business.

In a time when digital assistants Alexa and Siri have become household names, it should come as no surprise that artificial intelligence (AI)-enabled ERP systems are also becoming mainstream. Originally leveraged to automate mundane tasks, today’s AI is equipped for heavier lifting. Manufacturers can now use such technology to carry out complex tasks, sift through masses of business data and make snap predictions based on the information at hand.

With regulations changing across industries and businesses expanding across the globe, is your ERP system prepared to weather changing compliance requirements?

As we enter 2019, New Year’s resolutions may be on your mind – not only for yourself, but also for your business. Depending on your company’s goals, be it expanding your footprint or maybe venturing into a new industry, your ERP system may be facing a new set of regulations. Or, perhaps it’s your regulatory body who has resolved to revise their data standards in the years ahead. In either case, your organization will need a nimble ERP system and experienced software partner to remain in compliance. Below are three areas in which to remain vigilant in the year ahead.

Planning to expand your global footprint? First, ensure your ERP system is ready to support operations in international markets.

The term “globalization” used to be one used only by large corporations. International markets were once a sandbox exclusive to big businesses, where small and midsize businesses dare not venture. Today, progressive SMB manufacturers recognize that having an international presence is becoming synonymous with remaining competitive. Expanding your global footprint requires some investment, but like everything in business today, many of the logistics involved can be handled virtually. Adopting the right ERP system can help. Here’s how.

Generic ERP Systems are being replaced with tailored software solutions. What's driving the trend?

It wasn’t that long ago that when software providers said “industry-specific ERP,” manufacturers heard “inflexible software.”

But thanks to the democratization of the cloud and the proliferation of software-as-a-service (SaaS) providers, industry-specific solutions are becoming the way of the future for manufacturers. How has ERP software evolved to help manufacturers stay competitive within their distinct industries?

The Copley Consulting Group was honored to have recently received the Channelnomics 2018 Innovation Award in the area of Industry Achievement.  This award recognizes an investment of resources into our FDA Regulated solution for Infor CloudSuite Industrial ERP. This has resulted in rapid growth for the company and several recent customer wins, including Femasys, Blickman Industries and Pine Pharmaceuticals.

Is operating under one ERP system a requirement for successful subsidiary integration?

The rise of globalization and e-commerce, among other sources of financial pressures, has led to an uptick in mergers and acquisition (M&A) activity in a number of industries. For example, one Deloitte report found that 70% of large life sciences companies expected to be involved in some kind of M&A activity over the next three years.

As new technologies are introduced, how will expectations for tracking change for FDA-regulated manufacturers?

 A shift is happening among manufacturers in FDA-regulated industries. The popularity of generics, direct-to-consumer business models and the recent explosion of SKUs has brought new pressures to biotech developers, laying out new expectations for manufacturers. What was once a transactional relationship is becoming a more collaborative one, as developers and manufacturers partner together to obtain an edge in an increasingly competitive and complex supply chain.

What are the consequences of a faulty software validation, and what do manufacturers stand to gain in verifying their ERP system?

For a manufacturer in a regulated industry, such as a medical device or pharmaceutical firm, compliance is a responsibility that permeates through all facets of your business, including the software you use in your manufacturing processes. A critical step in implementing your ERP system is validating that the software meets business requirements in accordance with FDA regulations. Many of these specifications are detailed in the US Code of Federal Regulations (CFR) Title 21, including GMPs and Quality System Management principles that must be followed. However, compliance is more than just “ticking boxes.” Early attention to software validation can benefit your company in the long run. Here’s how.

With resources, capital and compliance on the line, how can you effectively manage risk during ERP deployment?

When you’re a small or midsize business in an FDA-regulated industry, implementing a new software can introduce a significant amount of risk. You’re dedicating a substantial portion of your annual budget to a system that will transform how you do business. This transformation is where the return on your investment lies, but to make it happen, you’ll need to manage your time, your resources and your budget – all while maintaining your compliance obligations. What could go wrong? Here are three scenarios to look out for during your ERP implementation – and how to get ahead of them.

How to confidently meet your regulatory obligations in a cloud-based environment.

Over the last few years, cloud-based ERP has become an increasingly popular option for manufacturers across industries. In contrast to an on-premise ERP solution, cloud ERP offers distinct advantages – most notably, easy online accessibility for employees who are away from the office. Deployment options for cloud ERP range from public, multi-tenant options to private, single-tenant clouds to hybrid models that lie somewhere in between. There is no one-size-fits-all solution, but as a life sciences company, you have regulations and compliance concerns to take into consideration. Below are some decisions you will need to make as you consider adopting a cloud-based ERP solution.

How to select an ERP system that will help you safely scale-up in an FDA-regulated industry

Startups in any industry must master the skill of achieving short-term scale-ups without losing sight of their ultimate goal. For life and small and midsize businesses (SMBs) in the sciences startups industry, the long-term target may be FDA approval, sustained profitability or acquisition.

In this special blog series, ERP for Small and Midsize Manufacturers, we’ll discuss how SMBs are gaining an edge in the Manufacturing industry through ERP software. From flexible deployment options to mission-critical functionality, you’ll learn what to look for to extend the value and shelf life of your next ERP system.

When your focus turns to growth as a small or midsize manufacturer, one of your first priorities is mitigating risk. We’ve already discussed how an ERP system can help strengthen your operations and keep your organization nimble when experiencing market shakeups. But how can ERP help SMB manufacturers prepare for a business shift they’re initiating themselves?

In this special blog series, ERP for Small and Midsize Manufacturers, we'll discuss how SMBs are gaining an edge in the Manufacturing industry through ERP software. From flexible deployment options to mission-critical functionality, you'll learn what to look for to extend the value and shelf life of your next ERP system.

The priorities of SMB manufacturers differ from industry to industry. The requirements for a medical device manufacturer will be very different from those of a custom shipbuilder.