Digitization

Enhancing Chemical Plant Operations to Make it Smart Factory Ready

Enhancing Chemical Plant Operations to Make it Smart Factory Ready

Enhancing Chemical Plant Operations to Make it Smart Factory Ready 700 500 Xcelpros Team

Introduction

Creating an Industry 4.0 smart factory requires time, planning, money and employee buy-in. Companies are advised to develop a roadmap showing what they want to do before they start. Improving communication through a digital platform ensures alignment between people, processes, and technology.

Smart factories are facilities using computer technology to transmit real-time status of every machine to a central hub. The data is used to make decisions on the spot, avoid production delays, and provide opportunities to improve efficiency.

In these factories, a combination of electronic sensors connected to a computer network provides a constant flow of information. When combined with artificial intelligence software, the computers make autonomous decisions, improving chemical plant production.

In the United States alone, 86 percent of manufacturers believe that smart factories will be the main driver of competition by 2025.Source: Deloitte

How it Works

Enhanced communication between machines means: Receiving tells Procurement what raw materials arrived and when. Procurement knows what supplies are on-hand and what must be ordered. Machine A has the materials it needs to create products. Machine B is working on a different product instead of being idle while waiting on Machine A. Machines A through Z are programmed to perform their jobs and let human workers know when potential problems may occur. Sales knows what finished products are available for shipping and what is in the pipeline. Customers know when they can expect deliveries in the time and quantities they require. Best of all, this information is available in real-time, so everyone knows potential problems and how they can work around them.

Acquiring data from the industrial internet of things (IIoT)-enabled devices and rapidly analyzing it turns standard factories into smart chemical plants.

These plants can rapidly view their entire supply chain from inventory to production to sales. Having the ability to keep track of production flow and ensure the supply chain flows smoothly is the function of specialized software such as Microsoft Dynamics Supply Chain Management.

Converting an existing plant using older manual devices, though, takes time, effort and money. Thought and a lot of planning are required to bring an analog factory up to this level gradually.

Critical smart technologies include hardware components such as sensors, industrial internet of things (IIoT) connections, factory floor networking connections and cabling plus data storage for millions—possibly billions—of datasets. Company computers—either on-premises or connected via the cloud—require software able to organize and manage the data using artificial intelligence. One such product is Microsoft Dynamics Supply Chain Management.

Figure: 1 Working of a Connected Factory

Connected Chemical Factory

Industry 4.0

As part of the Fourth Industrial Revolution, commonly known as Industry 4.0, smart factories build on computerization added to manufacturing processes in the mid 20th Century’s Third Industrial Revolution.

Above and beyond automating individual machines, Industry 4.0 smart chemical plants have:

  • Dramatically increased data collection, allowing more accurate decision-making.
  • Increased automation to encompass entire production runs. This produces goods more efficiently, including during times when humans are not present.
  • Improved flexibility allowing factories to mass-produce lots in any size from one unit on up.

5% Percentage of factories are fully “smart”.

30% Percentage of factories are being updated to smart status.

65% Percentage of factories are not making progress toward smart status.

Source: Deloitte Insights

Smart Factory Challenges

Factory owners face several potential barriers to converting an existing facility into a smart factory running more efficiently with minimal downtime and defects. These barriers may include:

  • Employees accepting ongoing training and developing needed skills. Deloitte estimates a 2 million worker shortage in the US alone over the next decade.
  • The cost of updating factory floor machines to include sensors and information sharing capabilities. Some existing machines can be modified, while others may require replacement.
  • Networking all data collection points to ensure a smooth, continuous information flow. The information can flow to a central server on the premises or remotely.
  • Accepting the concept that smart factories cover the entire company, not just the production floor.
  • Ensuring all updated devices are compatible and can be integrated into a complete network.

Leading the Conversion Change

Some companies appoint “change champions” to lead their company into the smart factory 4.0 era. These people are often tasked with making the technology updates relevant to workers.

Change champions, which Deloitte’s research suggests, should be from the top-down (e.g., upper managers) and bottom-up (e.g., factory workers), help gain employee buy-in.

Their chief focus is answering the question, “What’s in it for me?” from individual workers’ perspectives. For example, change champions explain how mastering automation gives workers the ability to head off potential problems before they occur. Fewer problems in the production process mean greater output—and likely more sales—which benefits the entire company.

Change champions also explain to staff how they will benefit by gaining the new skills smart factories require. Additional training equals more skills and that translates to more opportunities for improved pay and job security.

Chemical Plant Automation Devices

One step existing factories must take to become smart chemical plants is updating equipment. For example, valves that factory workers open and close manually should be replaced by semi-conductor enhanced valves that do it automatically.

Among the many chemical treating instruments required to provide a smart factory technology with the information it needs are:

  • Smart pressure transmitters equipped with microprocessors and semiconductor pressure sensors that can directly measure pressure in pipes.
  • Microprocessor-equipped differential pressure transmitters to measure flow rates, pressure and liquid levels of gases, fluids and steam.
  • Flowmeters for measuring gas, steam and liquid, including vortex models that permit correcting temperature and pressure.
  • Level transmitters equipped with microprocessor sensors for measuring levels in liquids.
  • Control valves such as eccentric three-way rotary valves for mixing or dividing fluids.
  • Temperature controllers to ensure temperatures are within a device’s operating range and notify personnel of potential equipment problems before they occur.

The combination of electromechanical devices such as these with monitoring software lets workers watch conditions on the smart factory floor from literally anywhere: an office in the plant or a laptop on the beach.

Computerized positioners lets trained workers know the deviation between a set valve opening and the actual valve opening. This knowledge helps workers detect signs of impending valve failure before it occurs.

Creating A Roadmap to Success

Companies wanting to update their factory to a smart chemical plant may want to follow a path similar to this one:

  1. 1.Map a smart manufacturing strategy based on each firm’s specific industry dynamics. Be agile and able to change direction when real values begin emerging.
  2. 2.Create a smart pilot project with proofs of concept that demonstrate the project’s value to the company. Embrace failure and learn from mistakes.
  3. 3.Define the required capabilities using a scalable data model. Ensure the technology used in one area communicates with that used elsewhere.
  4. 4.Identify smart manufacturing insights appropriate to the company, such as cross-functional data analytic teams. Share information between teams to avoid duplicating efforts while gaining additional insights.
  5. 5.Institutionalize new approaches to prevent older, less efficient methods from creeping back into the updated operations. Show the staff concrete examples of how the technology upgrades are making a proven difference in the chemical plant operations.

Figure: 2 Creating a Roadmap to Success

Roadmap to Success

Key Takeaways

  • Converting an existing factory to a smart chemical plant requires time, effort, money and patience. Factory owners and managers must overcome barriers on the way to achieving their goals.
  • One of the most important tasks is appointing Change Champions at the top (executive) and bottom (factory worker) levels who work together to get the entire workforce on board.
  • Advancing into the Industry 4.0 era means updating devices to provide a constant flow of data. Companies should create a roadmap showing how they will move from their current position to be a smart factory.

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Reducing the Risk of Pharmaceutical Non-Compliance with Technology

How Technology Can Reduce the Risk of Pharmaceutical Non-compliance

How Technology Can Reduce the Risk of Pharmaceutical Non-compliance 700 500 Xcelpros Team

At a Glance

  • Pharmaceutical manufacturing companies are investing more money and resources to assure adherence to regulatory compliance.
  • Non-compliances need to be managed and tracked through their lifecycle, and using a digital platform eases the end-to-end process and follows it to completion.
  • The first step towards regulatory adherence is to thoroughly understand the compliance requirements and form a dedicated process to comply.

Many pharmaceutical companies have restructured their financial and resource allocation models to invest more in adhering to compliance. Compliance requirements around the globe have grown in past decades. Each country has differences in safety standards, and global companies have to ensure they meet local requirements. Companies need better management and tracking of non-compliance. This article discusses the ways to reduce risks of non-compliance in the pharmaceutical industry. Manufacturers and distributors have dealt with compliance issues in the pharmaceutical industry. Companies have to conform to multiple complex and varying regulatory norms and safety standards. All the stages involve detailed compliance requirements, from procuring raw material to producing finished goods and quality testing of the final product. These complexities have further multiplied in recent years because of:

  • Addition of several more regulations globally in the pharmaceutical and life sciences sector.
  • Differences in the rules and regulations related to pharmaceutical compliance across different geographical regions.
  • Absence of a viable infrastructure to manage and track non-compliance.
  • Unclear SOPs and redundant record maintenance practices often lead to pharmaceutical manufacturing non-compliance.

Apart from these, non-compliance can result from other various smaller factors like faulty equipment, maintenance issues, faulty formula controls/ lab controls, etc. All contribute to quality compliance in the pharmaceutical industry. This is the reason that pharmaceutical and life sciences companies spend a fortune to avoid non-compliance. The costs of non-conformity are very high and thus, companies want to make sure that they adhere to the rules and regulations.

40%

of the pharmaceutical IT budget is spent on regulatory compliance.

Source: Gartner

Figure: 1 Major Factors Affecting Compliance in Pharma

 Major Factors Affecting Compliance in Pharma

So how can pharma companies leverage technology to mitigate the consequences of non-compliance? Here are some ways that experts believe newer tools and innovations can help in better pharmaceutical compliance management:

1.Making use of the right tools: Documentation and record maintenance are a big part of the pharmaceutical industry’s compliance processes. Conventionally these documents have been manually maintained, which can lead to both errors and oversights. However, newer pharmaceutical software platforms come with the ability to gather and store data efficiently. It is essential to track user behavior and user audits to ensure compliance. A compliance management system with audit tracking and reporting tools can avoid non-compliance and improve overall product quality.

2.Leveraging integrated labeling: Pharmaceutical companies struggle to manage compliance as they enter newer territories and markets. There are different labeling practices and regulations which are challenging to manage. The labeling practices keep going through changes and updates even in familiar territories, making it essential for pharmaceutical companies to stay on top of these changes. To tackle labeling issues, companies can leverage the automated labeling platforms wherein the data can be auto defaulted from the different processes such as receiving, production and shipments. Inbuilt label printing within business process workflows avoids user errors and enforces process compliance. With integrated labeling within the ERP, users are equipped to manage changes and make the labeling process run smoothly.

3.Standardizing processes across the organization with a common technology platform: Major pharmaceutical manufacturers and distributors are tying up with technologists to deploy a common technology platform and implement it across their locations. Companies that invest in business process uniformity will witness business improvement and growth. Quality issues often arise due to non-compliance of processes, undefined procedures, changing equipment and labels, etc. Many companies find that quality is impaired when processes vary from location to location. With the latest technology platforms, organizations can centrally assure that standardized practices are being followed across all locations.

4.Effective strategies to managing data: Non-compliance in the pharmaceutical industry is often a result of a poorly managed information loop. Systems supporting pharmaceutical manufacturing and distribution generate enormous data. When data is managed systematically, the right information is made available to appropriate users. The right system can notify regulatory changes, changes in formulations, or process variations. Every data point serves as a crucial piece of information that can guide users to be more proactive in conforming to business processes. Data management and analytics platforms are equipped to enable pharmaceutical companies to report anomalies as they occur. Dynamic reporting cumulatively helps in better quality compliance.

The Covid-19 pandemic has added impetus on pharmaceutical companies to adhere to regulations while working on therapeutics and vaccines at an unprecedented speed. Companies that leveraged the latest machine learning, analytics, and other IoT tools/ platforms, perform better.

Pharmaceutical companies are always looking for newer methods to balance quality compliance and productivity.

Johnson & Johnson, for instance, has a comprehensive quality management framework in place for continued focus on compliance and quality, amongst other essential parameters. The latest technologies and innovations back this framework.

All in all, reducing the risks pertaining to compliance issues in the pharmaceutical industry requires a well-planned and executed technological strategy. With the latest innovative platforms, companies can ensure adherence to quality compliance regulations in the industry.

Key Takeaways

  • ERP, automation, data analytics, and machine learning are imperative in enabling pharma companies to mitigate the risks of non-compliance.
  • To reduce the consequences of non-compliance, pharmaceutical companies need to strategize their technological moves.

Book a consultation to get started with our pharmaceutical compliance solutions.

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References: Reducing the Risk of Noncompliance

How do smart factories help boost your supply chain

How do smart factories help boost your supply chain?

How do smart factories help boost your supply chain? 700 500 Xcelpros Team

At a Glance

  • Smart factories can use technology to boost productivity and increase quality. Merging data and insights from the shop floor with the supply chain and the entire organization can uncover ways to improve operational efficiency and boost business relationships.
  • By connecting devices and sharing information, smart connected factories permit automatic optimization. The machines can adapt to changing conditions in real-time and run the entire production process without human intervention, a white paper from Deloitte states.
  • A smart factory is one where information is continuously shared between devices and resources. Sharing this information reduces waste, thereby increasing efficiency and productivity.
  • It impacts the supply chain by anticipating needs and automatically ordering materials. That in turn keeps the factory running at maximum efficiency.

The smart factory represents a leap forward from more traditional automation to a fully connected and flexible system.Source: Deloitte

Traditional factories tend to have discrete machines and production lines. Information gathered from one device stays with that device until manually uploaded into a computer network.

Smart factories eliminate the barriers between machines, using computer sensors to monitor every stage and every process, producing huge volumes of data. The information is shared vertically on the factory floor and horizontally with other departments. This method lets the company rapidly adapt to marketplace changes, expanding its offerings and encouraging innovation based on customer needs. Smart connected factories are much more than just machines knowing when to open and close valves. They integrate the entire operation—including supply chain, manufacturing, information technology (IT) and operations technology (OT)—into one unified, agile organization.

Characteristics of a smart factory

Smart factories share five characteristics. They are:

  • Connected across machines and departments
  • Optimized for reliability and predictability
  • Transparent for quick decision making and order tracking
  • Proactive for identifying potential problems before they occur and restocking materials before running out
  • Agile for quick changeovers and product modifications

Benefits of a smart factory

Important benefits of a smart factory include:

  • Using data to create pattern identification and mapping the production process. This method gains production insights and allocates resources more efficiently.
  • Identifying and logging all process problems from machine and worker input.
  • Identifying waste creation points and processes.
  • Sharing data not only with the factory floor but with sales, marketing, finance and other departments to improve overall results.
  • Mastering the smart supply chain, permitting advance ordering of critical components before running out of them and delaying production.
  • Customizing small orders, permitting small batch creation when machines are not in use on large projects.
  • Diagram an ideal state.
  • Develop a plan to make the ideal state a reality.
  • Monitor and continually adjust new processes—including educating and training employees—ensuring maximum efficiency.

How it Works

The information process begins by using machine sensors and operators to capture data points during the 7 Flows starting with the supply chain in the form of raw materials. Each of these flows is part of the Lean Manufacturing Process.

Seven Flows

The seven flows involve:

  1. 1.Raw materials
  2. 2.Work in progress
  3. 3.Finished goods
  4. 4.Operators
  5. 5.Machines
  6. 6.Information
  7. 7.Engineering

All of the flows working together tend to efficiently produce products with few defects, Kettering’s article states.

Software such as Microsoft Dynamics 365 Supply Chain Management is designed with these concepts in mind.

For example, Microsoft Dynamics 365 Supply Chain Management allows factories to integrate industrial internet of things (IIoT) and artificial intelligence in the process flows.

Technical Advances Enabling Smart Connected Factories

Recent technical advances permitting the creation of smart factories include the development of:

  • Sensors collecting information, providing access to various activities and processes.
  • Using connected IIoT (Industrial Internet of Things) devices transmitting the sensor data to a database that in turn, massages the data to identify and correct inefficiencies.
  • Analyzing data as it is being collected. This permits rapid responses to changing situations, such as correcting a manufacturing defect as it occurs.
  • Employing AI (artificial intelligence) coupled with machine learning permits self-correcting when detecting errors such as closing an open door that might affect a temperature-sensitive section.
  • Relocating some IT resources to “the cloud.” Cloud Computing reduces data costs by transmitting it to a remote location where an interconnected network of computer servers processes, shares and stores data in a secure location away from the factory.
  • Running a digital version of a process in advance. By identifying and correcting potential errors and sticking points in advance, actual production is not affected.
  • Keeping data secure from outside cyber threats and attacks such as ransomware or hacks that steal data or damage or destroy critical components.

When many people think of the Internet of Things (IoT), they visualize home products such as lights that turn on and off when people enter rooms, saving electricity. Maybe they consider newer smart refrigerators that let homeowners use an app on the attached touchscreen monitor to order food items when they are running low.

The IIoT expands this connectivity from computers and the home to computers and industrial machinery. For example, it allows remote workers to monitor temperatures and automated chemical blending, ensuring the correct mixtures.

Figure: 1Functions coming together within smart factory

Functions coming together within smart factory

Why Update Now to a Smart Factory Solution?

The rapid pace of technological innovations means that the cost of making some of these updates—computing speeds and data storage, for example—has dropped. Technology is more sophisticated allowing systems not only to gather information but interpret it and automatically make adjustments.

A more complex supply chain means manufacturers must be more nimble than ever before while also adapting to constantly shifting priorities.

Merging parts of IT with parts of OT, in combination with device hardware and software such as Microsoft Dynamics 365 Supply Chain Management lets factories analyze their data now in real time for smart supply chain management.

Smart Factory Categories

Smart factories come in four categories, all based on data.

  1. 1.Available—but not accessible—data that must be organized before being transmitted.
  2. 2.Accessible data, which is organized and stored in ways that permit analysis.
  3. 3.Active data, which can be analyzed by computer software such as Microsoft Supply Chain Dynamics 365.
  4. 4.Machine-controlled modifications using solutions identified earlier, all with limited human input.

Making Factories Smart

Owners and managers may want to start with a single device, get it working the way they wish and then gradually expanding to a full production line. Companies considering updating an existing factory will need to have methods of obtaining data from the factory floor, which might require updating or replacing some machines. The cloud can help with processing and storing the information but data collection takes place locally.

Investments in other technologies—including AI, augmented reality and optical sensors—may be required to understand the data and digitize the production process.

Another important change is staffing. Even though much of the work will be automated, skilled workers are still required. This could involve realigning departments and eliminating or drastically changing individual roles.

Key Takeaways

  • Technological changes are turning the dream of smart factories into reality.
  • Smart Factories have the ability to highly automate many repetitive steps using a combination of device sensors and computer software.
  • Factory data can be used to create artificial production lines. Running them virtually lets managers spot potential problems before affecting actual production.

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Clearing the Air About Cloud- 7 Cloud Myths Debunked

Clearing the Air About Cloud: 7 Cloud Myths Debunked

Clearing the Air About Cloud: 7 Cloud Myths Debunked 700 500 Xcelpros Team

At a Glance

  • Cloud migration is one of the most prominent IT overhaul strategies that many companies need go through to become more agile.
  • As often witnessed with any new technology (and its offerings), there are certain misconceptions about cloud computing, migration to the cloud and data security.
  • To harness the most out of your company’s investment in the cloud, you need to understand the misconceptions and be able to see past them.
  • Upper management needs to realise the significant business gains when moving to the cloud.

Agility and flexibility are perhaps two of the biggest drivers for companies looking to overhaul their IT infrastructure. For many companies, cloud adoption is an important step in that direction.

74%

of participant companies have moved a cloud-based app back on their premises after failing to see an anticipated return.

Source: HIS Markit

The upper management and IT departments of most companies often start with a vision of unlimited possibilities when they begin exploring the idea of integrating their IT strategy into the cloud, and often get discouraged because they buy into certain cloud myths and misconceptions. These myths can often poison an otherwise perfect vision, making it difficult to see the real benefit that migrating to the cloud can offer any business. From an early stage, it’s imperative to understand that simply transitioning to cloud computing is not a one-step-solution for better performance. You will need to make it work for you – and that’s the beauty of computing in the cloud, you can customize your experience to suit your unique business needs.

The first step is to dispel misinformation in some of the most commonly heard cloud computing myths.

7 Common Myths about Cloud

1.Cloud is All About Cost-efficiency: Many CIO’s we come in contact with have a notion about the cloud – that it is (or should always be) the cheaper option. Truely, when you compare CAPEX vs. OPEX, the cloud is most certainly a cost-effective option. Unfortunately, this is a somewhat layered and nuanced determination. It should be understood that the initial migration of workload to the cloud can be a very disruptive and resource-intensive process. There can be latency issues and if the entire strategy is not in place before the migration begins, these issues can multiply rapidly.

2.Everything in Cloud is Automated: The cost of skilled resources often gets forgotten when a company believes that the cloud can operate without interaction. While it is true that the cloud offers high levels of automation and many self-reliant features, there will still be a need for skilled professionals to manage the infrastructure. Additionally, simply managing and maintaining the cloud will continue to require human intervention.

3.Security on the cloud is not on par with in-house data centers: This is by far one of the most prevalent cloud myths that becomes a major sticking point and concern for CIOs. While data security is not something to be taken lightly, the fact is that cloud computing security issues only occur because of failure to adhere to regulations and governance guidelines. In fact, in recent years, cloud service providers (CSPs) have invested millions in strengthening their security capabilities.

Figure: 1Know Your Cloud Concerns: Myth or Fact?

Cloud Concerns Myth or Fact?

4.Application-wise transition to cloud is the best way to go:A lot of planning goes into cloud adoption and migration strategies. However, a common misconception is that the transition needs to take place for each individual application. Doing it this way results in significantly higher costs for the company as they end up paying more for the in-house data centers and the CSPs to host the apps. The right way is to move entire business domains to the cloud at once.

5.The downtime in cloud migration will have a huge impact on business:While it’s true that any big transition can be intimidating, companies are most often apprehensive about migrating to the cloud because of the misinformation regarding downtime and other difficulties involved. This is one of the older myths, no longer applicable as the larger number of experienced service providers available to help companies smooth the transition all but eliminates this risk.

6.Cloud is yet to approach maturity:We may have all heard this by now, and we’ve been hearing it a long time – the benefits sound enticing, but the cloud is still at a nascent stage and the many disadvantages of cloud computing present red flags, but this is no longer entirely true. In fact, the rapid pace of new innovations when it comes to the cloud is because the cloud in fact has reached maturity, and will only get better from here.

7.Moving to the cloud can cost jobs:Cloud adoption often meets with resistance as there’s a big misconception that it will lead to resources becoming obsolete. Fortunately for us, this couldn’t be farther from the truth as the constant innovations in the cloud are actually paving the way for more opportunities for skilled professionals. In the future, we should see educational branches dedicated to training young coders and developers in shared, public and dedicated cloud environments.

Misconceptions can lead a company in the wrong direction. Knowledge about the cloud and understanding the benefits helps you discern the myths to unlock your business’s true potential. Modern cloud computing capabilities far outweigh the difficulties in cloud adoption and should support your vision every step of the way.

Key Takeaways

  • Companies need to look at the cloud as a comprehensive step towards agility and flexibility and not simply as a cost-effective investment.
  • Getting skilled professionals onboard is imperative to dispel cloud myths and get the maximum ROI.

Book a consultation on cloud migration.

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References: Debunking seven common myths about cloud

ERP in developing the operational efficiencies in Pharma

Impact of ERP Software in Boosting Operational Efficiencies for Pharma

Impact of ERP Software in Boosting Operational Efficiencies for Pharma 700 500 Xcelpros Team

Introduction

Increased efficiency is an ongoing goal for any organization looking to stay ahead in today’s market, especially those in the Pharmaceutical industry. There’s often a lot of focus placed on things like increasing productivity, lowering operating costs, enhancing operational efficiency and improving product-based profitability, to name a few.

On top of that, pharmaceutical organizations need to devote a considerable amount of time towards operational planning, drug commercialization, go-to-market strategy and more.

While today’s best-in-class companies conduct these operations using automated tools, smaller pharma and biotech companies end up handling these operations with manual processes. Especially for these companies, a modern Enterprise Resource Planning(ERP) system that can handle end-to-end business processes and be used to collect, track, manage, and distribute critical information across all departments is invaluable.

A few high-level benefits of a modern ERP System include the ability to

  • Standardize business processes and enable automation across different departments.
  • Monitor business processes across departments to accelerate operations.
  • Allow visibility and transparency by data sharing.
  • Establish strong collaboration across multiple departments.
  • Provide a multitude of flexibility and customization options to meet specific business requirements.

Modern ERP systems

Today’s ERP systems have evolved into powerful, agile platforms designed to integrate core and incremental business functions into one unified system. These modern ERP applications automate the flow of real-time information across departments, allowing easier collaboration and actionable insights to help drive important business decisions.

Based on experience, here are some of the differences seen in higher-end ERPs.

ERP SYSTEM ORACLE SAP MICROSOFT
ATTRIBUTE      
COLLABORATION MEDIUM MEDIUM HIGH
LOW CODE INTEGRATION MEDIUM MEDIUM HIGH
USER ADOPTION MEDIUM LOW HIGH
UPGRADE COSTS HIGH HIGH LOW-MEDIUM
CHANGE MANAGEMENT MEDIUM MEDIUM MEDIUM
ENHANCEMENT COSTS MEDIUM HIGH MEDIUM
EASE OF INTEGRATION LOW LOW MEDIUM
SCALABILITY TO BUSINESS GROWTH HIGH HIGH HIGH

Different Types of ERP Deployment

01. Cloud

A cloud-based solution delivered over the internet using Software as a Service (SaaS).

Benefits

  • No upfront cost for hardware and software
  • Remote access to critical business applications
  • The cloud vendor manages costs related to updating and upgrading.
  • Datacenter takes care of IT support services.
  • The company server is secured against the threat as the data is stored in the cloud.
  • Cloud services are scalable and can be consumed as per the requirement of the business.

02. On-Premise

The ERP system is installed locally in the client environment, and data is stored on internal servers.

Benefits

  • More customization options are available and with greater ability.
  • The organization holds control over the implementation process.
  • Data security control remains in the hands of the organization.

03. Hybrid

Splitting ERP functions between on-premise systems and the cloud server to receive the best outputs.

Benefits

  • Increased flexibility allows loose coupling among modules.
  • An intermediate cost between cloud and on-premise solutions.
  • Lesser training expenditure involved compared to cloud ERP.

93%

percent of organizations apply cloud-based software or system architecture. Also, the application of hybrid cloud systems has escalated from 19% to 57% in 2017, a three times rise in a year.

Source: Mcafee

The role of ERP in the Pharmaceutical industry

At present, the pharmaceutical industry faces numerous business challenges including

  • Major healthcare reforms
  • Rigorous regulatory requirements
  • Incalculable market trends
  • A discerning and demanding customer base
  • Increasing global competition
  • Lower drug prices demanded by consumers

The growing consumer demand for superior-quality healthcare products at compelling costs and the competitive market makes it essential for pharmaceutical companies to streamline operations, reduce cost, and maximize efficiency.

From planning and purchasing to things like inventory, supply chain management, sales, marketing, and human resources, a modern ERP technology solution can enhance operational transparency with better collaboration across all departments.

Why do companies choose ERP?

When current systems become the reason for slowed business growth most companies start looking for other options. Some companies just want to positively change the way they function and switching to an agile ERP system can help trigger a major change.

Some additional reasons a company may choose to implement an ERP solution include

  • Improving business performance
  • Making employee jobs easier
  • Satisfying regulatory compliance
  • Improving system integration

Reasons for Budget Overrun

One of the big detractors of new ERP implementations is budget, as it can be easy to underestimate the complexity involved. There are numerous reasons for a budget overrun during an ERP implementation, including

23%of budget overruns take place due to unexpected technical issues.

22% for the additional technical necessity

20%for increased scope

17% for underrated project staffing

The benefit of ERP for Pharma companies

In an industry that is so highly regulated, implementing an ERP can help streamline your organization’s ability to operate efficiently. Below are a few major benefits that pharma companies can gain from a modern ERP

  • Streamline production floor processes leading to a higher production rate
  • Manage sales & purchases in a few simple steps
  • Closely monitor and control inventory, including raw materials
  • Minimize operational work by sending real-time data alerts across departments
  • Increase operational performance accuracy
  • Ability to perform WIP and yield quality testing for an item or group of items
  • Save time and operational expense
  • Limit material wastage with pre-expiry alerts
  • Help maintain and manage compliance
  • Track the distribution of manufactured goods
  • Enhanced customer support
  • Maintain records of all business transactions through extensive reporting
  • Allow remote access to data to help make better business decisions 24/7
  • Handle all payments including customers and vendors

Challenges implementing an ERP in the Pharmaceutical Industry

Despite widespread ERP usage, there are still companies that face difficulty moving to a modern solution. Can the same ERP implementation strategy and formula work for every business? Unfortunately not, as each organization follows a distinct process, and has unique needs and expectations.

Here are a few challenges that companies usually encounter:

  • Selecting the ERP software that best meets their companies requirements
  • Attempting to complete the implementation in one step leading to numerous unforeseen problems
  • Crossing the budget limit because of project schedule overruns due to poor planning
  • Encountering compatibility issues with different ERP modules

Don’t forget

Finally, here are some things to consider when you begin the task of finding the right solution

  1. 1.Conduct in-depth research before selecting any ERP software. It’s wise not to make a decision based on a high-level feature list alone. Rather, go by detailed research that includes an understanding of the entire project.
  2. 2.Analyze your specific business requirements. Before choosing any ERP application, define a clear vision of what you plan to achieve from the ERP Solution.
  3. 3.Work with a partner that provides a free assessment. This process gives you the ability to break down the project into easy to manage pieces.
  4. 4.Evaluate the Return on Investment (ROI). The initial investment cost in an ERP solution may seem high, but the long-term benefits more than outweigh the initial cost. Understand from what specific solutions you need, and you can more accurately determine cost.
  5. 5.Ensure appropriate personnel training. Your team needs to hold a clear overview of how to use the ERP application. Initiating a mandatory training program for all users should help solve any such issues that may arise.

Key Takeaways

The right ERP solution, along with proper planning can improve your business processes and catapult your business to the top of it’s game.

Organize your operations today, to lead your company to success tomorrow.

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Rethinking pharmaceutical strategies in the new normal banner

Rethinking Pharmaceutical Strategies in the New Normal

Rethinking Pharmaceutical Strategies in the New Normal 700 500 Xcelpros Team

At a Glance

  • The year 2020 showed the world that every sector has to be prepared for disruptions of unprecedented scales. This has been especially true for the pharma industry, which already had stagnant operational models and a lack of consumer connection.
  • Working on a new pharmaceutical strategy model is a necessity and top executives at pharma companies concur that there is a need for integration of the latest technologies in pharmaceutical and life sciences operations.
  • Industry leaders have demonstrated that during difficult times they are able to quickly respond to changes and are nimble in adopting newer ways of running operations. This quick-to-adopt way of leading will enable pharmaceutical companies to succeed in the new normal.
  • Agile technologies and tools that streamline processes will be indispensable in the latest roadmap of pharmaceutical strategy.

The pharmaceutical sector has been traditionally apprehensive towards adopting newer technologies and methodologies. Compared to other industries, operations management within the pharmaceutical industry has not been quickly modified or completely transformed. C-suite executives are now looking to overhaul their pharmaceutical strategies ensuring growth in the new normal.

During the pandemic pharma supply chains were adversely impacted and witnessed supply-demand discrepancies. Companies that could quickly adapt rose to the challenge. The spirits have changed since the onset of the pandemic and so has the market. Thanks to visionary leaders, pharmaceutical companies began work on something that the world had never witnessed before – to develop and test drugs/ vaccines for a novel pathogen in mere months’ time since the gene identification.

70%

of leading pharmaceutical executives (respondents of the survey) were optimistic that the industry will continue to grow over the next 12 months.

Source: GlobalData Survey

This optimism calls for a strategy that enables companies to –

  • get their supply chains back on track
  • optimize operations
  • effectively handle the shortage of workforce
  • leverage the latest technologies for accelerated production and overall better
  • create more personalized patient connections.

However, the path ahead is not without its set of challenges. After all, the pharmaceutical sector has been conventional in its outlook when it comes to newer technology adoption. There are also challenges related to budget, upskilling of employees, technological glitches and more. Companies need to gauge the path ahead and handle the challenges faced by pharmaceutical industry in 2020 and beyond.

Steps towards Transforming Pharmaceutical Strategies

1.Recognize Best Practices and Retain Them:The path to recovery is a tough one as it involves undergoing quite a metamorphosis. However, this does not entail letting go of all the practices. Pharma executives would need to analyze their operations and chalk down the practices, tools and technologies that have worked the best for them and also have the potential of harnessing benefits in the future. Continuing these practices will make restructuring in other facets of pharma operations a relatively smoother task.

2.Restructuring Assets for Process Streamlining: Be it the shop floor operations or inventory management or handling the entire supply chain– a new pharmaceutical strategy would be truly beneficial when pharma companies reassess and restructure their assets. This would fortify individual practices resulting in overall process optimization. It would also help to let go of stagnant and redundant technologies or practices to make way for more agile tools.

Figure: 1Pharmaceutical Strategies Breakdown: Towards the New Normal

Pharmaceutical Strategies Breakdown: Towards the New Normal

3.Adopting Digital Drivers of Change: The new normal is eventually going to be the only normal and thus pharmaceutical companies need to harness potential through digital tools and technologies. After retaining the best and letting go of the redundant, pharma operations would benefit greatly by using tools for Enterprise Resource Planning (ERP), Supply Chain Management (SCM), Customer Relationship Management (CRM), Artificial Intelligence (AI), Machine Learning, Big Data, Advanced Analytics etc. These tools and technologies would help in process automation, centralized data access, real-time supply chain monitoring and a lot more. Many pharma companies are looking at the digital revolution as their segue to pharma 2.0.

For instance, pharma giant Sanofi has already rebooted it’s digital strategy and is now ramping up operations in marketing, research and even e-commerce.

4.Moving from a Product-centric to a more Patient-centric Model:The healthcare sector is transforming and is becoming more personalized. With access to information and medical assistance becoming quite easy through smart devices, the consumers are highly aware of what they want. This is the pharmaceutical sector’s chance to connect with their end-users and know their requirements. The overall shift to become a patient-centric industry would take time and effort, but it is the right step. In fact, patient-centricity is already one of the key goals for many pharmaceutical companies, contract research organizations (CRO’s) and contract development and manufacturing organizations (CDMO’s). For example, the contract research organization, Parexel has hired its first-ever chief patient officer, with a focus on boosting clinical trial diversity for better results and ensuring that their drug is scalable to multiple demographics.

These points of considerations serve as the platform for companies to work on their renewed pharmaceutical strategies. Of course, every company has its unique set of operations, models and unique challenges. However, optimizing operations and leveraging digital technology to expedite growth are common must-haves for a pharmaceutical company’s renewed business approach. After all, the new normal will bring as many opportunities in the form of challenges and a well-equipped pharmaceutical company can harness the most out of its investments and talent-pool.

Key Takeaways

  • Even though the pharma sector has been slow to adapt to newer technologies, the dynamic changes in the past decade seemed to have enabled the industry to step up to the challenges posed by the Covid-19 pandemic.
  • A change in perspective is essential for success in the new normal and to rethink pharmaceutical strategies. Equally important is the communication of the perspective of this change from top management to employees.
  • Pharmaceutical companies would need to make use of the data being collected to generate insights and know exactly what their end-users need. Transforming to a more patient-centric business with the help of the right digital platform is the need of the hour.

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A Comprehensive Approach to Digital Transformation in the Chemical Industry

A Comprehensive Approach to Digital Transformation in the Chemical Industry

A Comprehensive Approach to Digital Transformation in the Chemical Industry 700 500 Xcelpros Team

At a Glance

  • Chemical companies can unleash their business potential with end-to-end integration of digital technologies for manufacturing and distribution. Software for chemical industry has been met with enthusiasm as well as apprehension, given the multi-faceted and conventional nature of this sector.
  • Digitization of systems, processes, and functions comes with challenges and chemical companies need to implement solutions to navigate them through them. Newer innovations and implementation strategies are the need of the hour to ensure chemical companies thrive in the market.
  • End-to-end digitization for chemical companies will be a process filled with opportunities and hurdles. With a pre-planned blueprint, an organization can maximize the overall value from investment in digital technologies.

If one thing the ongoing Covid-19 pandemic has taught the world, it is the importance of being agile. The need for a digital transformation to cloud systems has gone up during the pandemic. Fast-growing companies rapidly transform into newer technologies that can help them grow. Your workforce may not be ready and may even resist the change. Leaders of rapidly growing companies set the right message that end-to-end digitization is the right step to set a company for success. Digital transformation will only help with day-to-day tactical work and despite the change management issues that need to be handled, changes in technology that drive progress are always best for an enterprise.

42%

of chemical company CEOs will prioritize digital operations and related technologies in the coming year.

Source: PWC, 23rd Annual Global CEO Survey

There is no denying that Chemistry 4.0 will undergo a digital evolution on the shop floor and other departments. End-to-end functions at a chemical company will improve by leveraging technology for collaboration, operation, and customer experience, all on a single platform. Here are some of the ways that digitization in chemical industry could help manufactures, researchers, distributors, and consumers:

  • An R&D lab will be more efficient with integration tools that facilitate automation, machine learning and data analytics. Researchers can synthesize molecules in a controlled environment and replicate the results with exact precision.
  • Manufacturers can scale up their production and optimize processes for enhanced efficiency and reduced operational costs.
  • With the help of the right Enterprise Resource Planning (ERP) platforms and Supply Chain Management (SCM), manufactures can automate various processes, get real-time updates about inventories and can effectively manage coordination between multiple stakeholders.
  • Digital innovations in the chemical industry can also help with better waste management and track environment health and safety data integrated into their ERP.

With the list of incentives being so persuasive, why are new technologies in the chemical industry met with apprehension? The answer lies in the conservative way of functioning within a chemical company coupled with varying safety regulations and guidelines worldwide. Let us have a look at some of the challenges in digital transformation within the chemical industry.

End-to-end Digitization: Challenges in the Chemical Industry

1.Where to begin?Many chemical companies struggle to strategize their digitization journey. Defining the companies’ goals and aligning them with the right technologies requires expert consulting and a clear vision from the C-suite executives. Often diving the digital transformation without a plan or the expertise leads to bottlenecks and unforeseen issues.

2.Upskilling of the Employees Newer technologies require training, practicing for error-free implementation and seamless operation. Upskilling employees from different functions to harness agility benefits from digital technologies can be a massive task for chemical companies. There are also issues related to training costs and addressing the behavioral resistance when it comes to change management.

3.Digitization in Silos Digitization in chemicals often happens in silos, given the multi-faceted, vast nature of a chemical manufacturing and distribution setup. However, when different functions or departments implement digital technologies without a centrally guided plan, the results will be different than what was expected from the technology. Multiple issues related to data discrepancies, systems incompatibility and process inefficiencies have been reported when the system is implemented without the right methodology.

So how should chemical industries look at end-to-end digitization? First of all, it’s important to remember that there’s no one-size-fits-all solution for every organization. Every chemical company needs to chalk out its roadmap when it comes to the adoption of digital technologies. However, certain industry best practices can help chemical companies make the journey towards digital transformation a smooth one.

Best Practices for Digitization:

1.Aligning Transformation Goals with Digital Technologies: Is your goal to improve your chemical manufacturing processes? Are you looking to digitize the entire supply chain? Is your focus more on customer relationship management? Answering these questions is an important step towards defining your goals to align them with the technologies. Organizations should also prioritize the goals to devise a phase-wise transformation plan for your chemical company.

2.Be Flexible and Dynamic: Any transformation comes with challenges that can potentially turn into dead-ends or cost-intensive pitfalls. During such scenarios, the digital transformation strategy needs to be flexible enough to pivot if required. This will leave room for accumulating changes without affecting the overall plan of digital transformation, the timeline and eventual outcome.

Figure: 1End-to-end Digital Transformation in Chemical Industry: Bird’s Eye View

End-to-end Digital Transformation in Chemical Industry

3.Get Experts Onboard: Any company wide change requires experts who are qualified to drive change. The same holds for end-to-end digital transformation in chemical manufacturing. Getting expert consultants onboard will make the transformation process smooth and open doors to newer possibilities.

4.Be prepared for issues: Many digitally mature companies understand the issues that need to be reviewed and fixed when a new system is implemented. It is essential to keep track of issues as they occur due to data and process inefficiencies. Anticipating the risks through a risk analysis and a mitigation plan will help companies reduce the pain of post-go-live issues.

5.Go for a Phased Implementation Plan: Even though the eventual goal is end-to-end digital transformation, chemical companies should opt for a phased implementation plan. This helps in detailed planning for every phase and also prevents the process from becoming too overwhelming.

Business Scenario

Mitsubishi Chemical Holdings has expanded efforts to use measured data to operate its plants. The company has developed and is now using Real-time DB, a remote monitoring system across its chemical plants. “By using this system, Mitsubishi Chemical can analyze operating conditions when there are technical problems and also improve day-to-day plant operations,” says Masanori Karatsu, senior managing corporate executive officer at Mitsubishi Chemical Holdings. The company is evaluating digital technologies and IIOT in other areas, including working with customers on product and new businesses development.

Such a centrally planned and phased approach has been adopted across many chemical companies.

To sum it up, end-to-end digital transformation in a chemical company would require planning and an execution strategy. Despite short-term disruptions, this change would bolster the manufacturing processes and enhance profitability in the long run.

Key Takeaways

  • Chemical companies have fierce market competition and digital technology for chemical companies can eliminate process and data inefficiencies that ultimately lead to better customer retention and stay ahead of competitors.
  • A planned, phase-wise approach would help chemical companies get the most for their buck when going agile. Users need to be change agents instead of being change averse.

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Top 5 reasons why ERP Transformation drives business success

Top 5 reasons why ERP Transformation drives business success 700 500 Xcelpros Team

Introduction

Have you seen a dip in your ERP system performance? Is your system breaking down every now and then? Is your current ERP able to support your rapidly growing business? As business transactions increase with time, you may notice spikes in system inefficiencies. You cannot expect to improve the company’s overall productivity with a legacy system that is barely functioning and outdated. You cannot report actionable insights while dealing with bad data and inefficient processes. By now, you have enough indications that your business is outgrowing the current ERP system. However, like most companies, you probably hesitate to transform your ERP, as there is an inherent fear about the cost of transformation and the company’s inability to accept change.

Three-fourths of ERP transformation projects fail to stay on schedule or within budget, and two-thirds have a negative return on investment.Source: Mckinsey

Interestingly enough, the above stat also forces companies that desperately need an ERP change to be better planned and prepared for the transformation. Companies that cannot transform quickly soon become irrelevant.

The only thing harder than transformation is, failing to transform.

ERP transformation SWOT

Many industry insights have proved that the rate of failure is significantly higher when organizations are unable to embrace change. There are various reasons to move on from your existing legacy systems. Read on to know more about the five reasons you need an ERP transformation.

1.Your current ERP system does not have systemic collaboration capabilities Most old-age ERP systems run in silos and process transactions independently for each department. Some don’t even have cross-functional capabilities. This can pose an issue when you are trying to eliminate inefficient business processes. Archaic ERP systems rely on manual/paper-based methods for inter or intra-departmental collaboration. You rely on your team’s verbal communication and expect them to be on top of their tasks, especially while handing them off to other departments. Most of the process inefficiencies arise due to poor communication. For example, your manufacturing and finance departments interact manually or through paper. As the volume of work orders goes up, the teams quickly lose track of operations that need to be verified and closed out. These delays can cause inventory inaccuracies and bad data.

Figure: 1A real life manual production process prior to transformation

Production Process before ERP Transformation

Notice the number of failure points in the above figure. Now imagine many of these failure points across different production scenarios. While some organizations are very good at tracking manual communication, the onus is always on the team to communicate effectively and move work orders forward. Secure, streamlined, efficient collaboration is the focus of most modern-day companies. Businesses that want to succeed will empower their team to collaborate from anywhere effectively.

2.Your ERP system does not have embedded advanced analytics and BI dashboards Most Agile companies prefer Analytics and BI dashboards within their operational ERP systems. Organizations with profitability as their primary objective always favor tracking efficiencies and inefficiencies. Success or failure depends on the ability to respond to aberrations instantly. BI applications are separate from an operational ERP system by design. A powerful BI application collates data and provides analytical insights. Integrating an obsolescent ERP to a standalone analytics application is cumbersome and does not offer real-time analytical reports. You may lose the capability of embedding a quick and easy BI dashboard onto your ERP that provides real-time progress reporting.

Ultimately, the more visibility you have of operations, the better equipped you are to make accurate business decisions. Once you notice an inability to report actionable insights, it is time to move on to a new ERP with better systemic capabilities and real-time reporting.

3.Your ERP system cannot leverage the power of AI and process automation It is a known fact that various industries have embraced AI to enhance their ability to predict user behavior. The prediction criteria include historical data, continuously improving processes, day-in-the-life activities, and adaptability to process improvements. On a similar token, many modern companies have adopted process automation to increase overall operational efficiency. AI and process automation are not just fancy technologies for larger companies. They are active enhancers that also help small and midsize companies to grow their businesses. Without your ERP integrated into AI, the system will not have the capability of continuous learning-to-enhance productivity. If you are still on an out-of-date ERP system, the chances are that you cannot leverage the power of Artificial Intelligence and process automation. When combined with advanced analytics, AI improves your supply chain’s end-to-end visibility and predicts possible disruptions before they occur. It now calls for a business decision if you are willing to decommission a legacy system that cannot utilize AI’s potential and plan your move to a modern platform.

4.Your current ERP system is less secure and more susceptible to data breaches Companies that are functioning on legacy systems tend to be more vulnerable to security threats and data breaches. You may not have the ability to protect your data and audit ‘who did what’ in the system. Most businesses store sensitive information like customer pricing, credit card numbers, employee records, company’s intellectual property, formulations, etc. If you are on an aged ERP, it may be challenging to ensure data privacy and security. Losing Information can be daunting, especially if you have no secure backups of data. How do you ensure that unauthorized access has not occurred and your information is not compromised?

Responsible companies do not risk customer information. They agree that short term pain and cost of an ERP transformation will any day benefit them, eventually leading them to long-term business gains.

5.Your current ERP system is not Agile and cannot accommodate incremental business needs An interesting question to ask yourself is if your technology can adapt to business process changes without customizing the system and violating industry best practices? Antiquated ERP systems are equivalent to following age-old processes. Enough research is done on this subject to help companies move away from outdated business practices and procedures. Companies are now choosing to be more nimble with changing times and stay afloat in a highly competitive market. Many companies within your sector may have already made the shift to newer, agile technologies – giving them the potential to outrun you in competition. Agile companies have the flexibility to function with higher efficiency, better ways to interact with customers/business partners, manage tasks smartly, and optimize resource utilization.

Research shows that agile organizations have a 70 percent chance of being in the top quartile of organizational health, the best indicator of long-term performance.Source: Mckinsey

As market dynamics change, the way you run your business should adjust accordingly. If you want to move out of working exhaustively, it is high time your company transforms towards being agile.

Why do companies move slowly to initiate the ERP implementation?

Below are a few hindrances that stop companies from moving forward with a technology transformation that will drive organizational change –

  1. 1.Cost of the changeover.
  2. 2.Businesses have difficulty following an implementation methodology that may challenge their current way of functioning.
  3. 3.Companies don’t have an internal change agent who can set end-user expectations, make tough decisions that may impact job descriptions and trigger a reorganization.

How do you overcome these challenges to move forward?

  1. 1.Have a set budget. Take a crawl, walk and run approach to the transformation.
    1. a. Crawl – Lift and Shift. Map your current business processes and convert them to the new system.
    2. b. Walk – Stabilize in the new environment, including handling issues, fixing them and maximize business operations.
    3. c. Run – Leverage all the additional optimization features on the application to boost the business.
  2. 2.Agree to a methodology that works for your company and doesn’t create too much resistance to convert.
  3. 3.Look for the right internal champion who understands the business and can manage user expectations effectively, especially when it comes to business changes that make users uncomfortable.

Final Thoughts

  • If you cannot move out of an old ERP system, your business challenges will continue to persist – further increasing sunk costs and lost time in the battle of quality vs. efficiency vs. cost of transformation.
  • Chalk out your organizational goals for the next five years to clarify why you should transform your business into a modern – agile ERP system and list your transformational goals.
  • Prioritize your ERP transformation into different phases by starting with lift and shift – to move your core business functions into the new system, and eventually implementing process optimization to utilize the real power of your new ERP.

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Rapid ERP Implementation

Rapid Implementation of ERP Systems- Benefits & Challenges

Rapid Implementation of ERP Systems- Benefits & Challenges 700 500 Xcelpros Team

At a Glance

  • ERP implementations are transitioning from being just a business choice to a necessity. Companies are now seeking ways for faster, smoother, and more economical implementation strategies.
  • An expedited ERP implementation strategy involves rapid methods that bring must-have features from legacy systems into a newer, agile and modern system.
  • Enterprises face many issues with rapid implementation, such as stringent scope, change management, limited customization options, etc.
  • Latest technologies and methodologies can make rapid ERP implementation a possibility for companies that want a higher ROI on their technology investments.

95%

of respondents improved some or all of their business processes after implementing a new ERP.

Source: Panorama Consulting

If enterprises were asked about their ERP implementation strategies a decade ago, the responses would vary widely. Many were skeptical, some were eager yet unsure and almost all who were positive, opted for steady onboarding into the new ERP. The continuing implementation model meant that employees were trained at a slow pace in the ERP, customizations were done as per requirements, and the budget was spread out. However, in the current day changeover to a new ERP is quicker making enterprises be agile and dynamic. Companies are lot more informed about the various technologies in the market and all they need is to plan the right time for the implementation and choose the right partner.

According to the report published by Allied Market Research, the global ERP software market accounted for $35.81 billion in 2018 and is anticipated to reach $78.41 billion by 2026, growing at a CAGR of 10.2% during the study period.

Many organizations are now opting for a cloud-based, rapid ERP implementation method, as they understand the benefits of the approach. The new decade demands companies to be more adaptable with a workforce that can quickly adjust to changes. In the past decade, companies that tried to get their employees be more nimble faced many challenges. Workforce could not promptly understand the market’s changing needs and adjust accordingly. They were usually overwhelmed, confused and unmotivated to move quickly. However, the new-age has limited choice to stay stuck in the same method of functioning, as many companies have already transformed to agile ERPs. The initial changeover may be painful but is necessary. Companies have to provide the right technology platform and help employees adjust to the new system. Once employee training and onboarding to the new system is done, they become accustomed to a continuous improvement procedure that drives growth.

The benefits of an expedited reorganization through quick ERP changeover makes enterprises go with a rapid transformation methodology.

Figure: 1Benefits of Rapid ERP Implementation

Benefits of Rapid ERP Implementation

Why do companies move slowly when it comes to deciding on a new ERP? CIOs look for some general points such as ERP system with proven business benefits, technology roadmap for the future, company’s ability to move into a new ERP rapidly, etc.

Challenges in Rapid ERP Implementation:

1.Reduced Scope of Customization: Any ERP system that is suitable for a rapid implementation has templates for users to easily fill data, and tools that can easily help users move to the new system. This eliminates the need for customized codes and also simplifies the use of the tool. Some companies may find this method constricting, especially when they intend to customize the application to fit their current business processes. Predefined templates allow companies to go with out-of-the-box functionality. The newer system may follow all industry best practices out-of-the-box and may restrict you from overly customizing the system to fit your historical business practices. To remove the discomfort of user adoption to the new system, companies customize the system and make it look like the old system. Rapid implementations restrict customizations, creating some change management issues. 

65%

of new implementation budgets go above plan due to customizing the ERP system during the project.

2.Challenges in Faster Change Management: Rapid ERP implementation process requires setting up a system that can manage end-to-end processes. The system however should be designed to scale and accommodate updates or future releases without too much effort. An expedited change management timeline can be tough on users especially if they are unable to adapt quickly. Aligning all the stakeholders, making them privy to the to-be changes, avoiding communication gaps, managing resistance, and sticking to the budget are some of the challenges organizations face when moving to an agile cloud-based ERP.

3.Data Migration Challenges: Moving from legacy to ERP requires collation, classification, and systematic migration of legacy data. In the case of rapid ERP, moving to the cloud requires thorough data scrubbing within a limited time to ensure that data is accurate. To avoid a drain on budget, companies engage an internal resources to clean up legacy data. The data migration process goes smoothly when data is cleaner and in the right format.

4.Managing expectations: Lastly, companies often look at an ERP as their be-all-end-all solution. Rapid ERP tools are made with reduced implementation time as a primary objective. There can be certain discrepancies in managing expectations with stakeholders. A proper internal champion or change agent who can spearhead the transformation can make the transformation easy on the company. Furthermore, managing employees’ psychological resistance and expectations can also be a hurdle for companies in the initial period of implementation, especially if the company has been on the legacy system for many years. An implementation needs an internal change agent who knows how to set user expectations and take a tough stance on situations, especially the ones that can spiral the implementation out of control. Without an internal champion, no matter how good your implementation partner is, you will see a drain on budget, time and a continuous blame that will make your project a failure.

With these challenges ahead, how are the systems integrators ensuring that companies can still benefit from rapid ERP implementations? The answer lies in setting the right expectations with the customer and leveraging the native tool kits of the ERP. For example, Microsoft Dynamics 365 Finance & Operations comes loaded with features that can give companies worth their money. The reliability, industry-standard templates, relevant functionality, and more such hallmarks make Dynamics 365 the go-to solution for faster cloud-based ERP implementations.

Microsoft Dynamics 365 Finance & Operations also enables step-by-step e-learning for its applications like the Task Recorder Resources that can run as a guide for users to learn the functions. With this app, users can record business processes for various scenarios and replay them as a guide. The feature speeds up change management and removes the user’s discomfort of not knowing the system.

The bottom line is that rapid ERP implementations are highly successful when companies go with native functionality and leverage the strength of the base system, rather than customizing the system. At least for the initial lift and shift, it is always recommended to stick with out-of-the-box functionality. Today, the digital era requires enterprises to become agile while leveraging newer technologies like cloud, process automation, etc. Rapid ERP implementations are a start to help a company become more nimble and adjust to market conditions quickly. So it is not always about ‘this is what I am used to doing’, it is about ‘what do I need to do differently to be successful’. We cannot avoid change and resisting the change will only push your company’s progress further. Companies will need to help their employees understand the benefits of going rapid so that the implementation and execution can be done on time and within the allocated budget.

Key Takeaways

  • Organizations need to be aware of challenges about rapid ERP implementation and be prepared with strategies to overcome these challenges.
  • It is crucial to remember that rapid ERP is highly beneficial to contain project costs and onboard users quicker into the new system. However, the chosen ERP should be able to handle most if not all organization’s needs.
  • Choosing the right tool for rapid ERP implementation is ‘half battle won’ for companies in their journey towards becoming agile.

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Role of electronic signatures in pharmaceutical quality control banner

The Role of Electronic Signatures in Pharmaceutical Quality Control

The Role of Electronic Signatures in Pharmaceutical Quality Control 700 500 Xcelpros Team

Introduction

Many life-sciences companies struggle to ensure stakeholders’ revenue growth due to low performing, paper based systems. Furthermore, they deal with challenges related to operational efficiency, productivity, product quality, return on investments, and compliance-related issues. Another key challenge is managing humongous data in paper systems or disintegrated systems that are hard to access, analyze, and report. If any of these challenges ring a bell, your primary focus should be on redefining your current business proesses and standard operating procedures. Rapidly growing companies are quickly revisiting their business process and procedures as the industry is evolving. They are moving towards simple, agile and powerful electronic business management systems to stay ahead of competition. Your ability to grow the business is directly related to your openness to change.

A cross-functional pharmaceutical organization has departments such as Procurement, Receiving, Quality, Inventory, and Shipping that may be disjointed. Business processes tend to be more reactive when visibility of operations is low. Rapidly growing companies embrace a paperless environment to improve operational efficiency, cut down costs, meet regulatory standards, and, most importantly, maintain complete visibility. Switching to a system with electronic signatures can help cope up with evolving quality conditions, and make your company more relevant in the current market conditions.

Life sciences companies need digital systems to support their core business procedures and follow the right implementation practices to pass all computer systems validation requirements. Having electronic signatures embedded in their ERP system will be a major benefit to pharmaceutical companies. It provides the additional validation and visibility of authorized personnel who approve the movement or release of inventory after passing quality control.

Most modern pharmaceutical companies are moving towards electronic signatures to track their business activities. This eliminates manual circumvention of any activities or violation of procedures.

The global e-signature market is expected to grow at a CAGR of 34.7% during the forecast period, to reach $9,073.1 million by 2023.

The following are a few processes considered for computer systems validation:

  1. 1.Purchasing – Raw materials and packaging materials purchased from approved suppliers.
  2. 2.Receiving – Incoming inventory received with the right paperwork requires validation by a supervisor of the receiving department or a Quality manager.
  3. 3.Batch Production – While verification of raw materials consumption, operations, and yields.
  4. 4.Quality – This is an absolute requirement for inventory on hold, waiting for batch quality testing before releasing material for consumption or shipments.

Figure: 1 Electronic signature in Microsoft Dynamics 365 Finance and Operations – Production order release function

Electronic signature in Microsoft Dynamics 365 Finance and Operations

One of the primary FDA regulations called ‘Title 21 Code of Federal Regulations (CFR) Part 11’ states that “Persons may use electronic records instead of paper records or electronic signatures in place of traditional signatures, in whole or in part, provided that the requirements of this part met, and that a docket stating a company’s intent submitted to the FDA.

The transition from a paper-based quality management documentation to a comprehensive digital record system is not simple; it involves an array of challenges. Below are a few:

1.Poor Data Management: Data is a key component of a CFR 21 part 11 compliant system. Poorly managed and stored data can cause havoc when an auditor comes to your doorstep. How intuitive you want the Digital systems ultimately depends on how well the data is stored in the system. Information that is all over the place without a proper structure will only increase more audit and compliance issues. It is a good practice to conduct a periodic data review to ensure that all of the necessary steps are executed within different departments or when interacting with 3rd party systems.

2.Managing Digital Signatures With companies’ transitioning to digital systems, regulatory agencies have formulated several policies to safeguard electronic signatures. Poor document control is a significant reason for companies’ failure of regulatory audits. A ‘hard to audit’ digital system opens it up to more manual documentation changes by end-users. Companies need to have robust security control with hierarchical approval procedures to preserve electronic information and avoid regulatory penalties. It is hence imperative that your ERP system has the necessary infrastructure to manage electronic signatures at different steps. These acceptable electronic signatures can then easily be audited and reported.

3.Mitigating Quality Management Issues The purpose of implementing an electronic signature software is to grow collaboration across departments in your company, and not just in quality control. How your end users adapt to quality management processes plays a crucial role in realizing a software’s true potential. The digital system helps generate faster resolutions to pending requests by auto-reminding end users. Adopting good documentation practices in the pharmaceutical industry is essential to drive away quality management issues to make your company more stable, reliable and growth-oriented.

4.Changing Complacent Corporate Culture electing an intuitive, easy-to-use system and overall organizational change management are two critical parameters to ensure a swift transition to a digital system. It is essential to make end-users understand the workflow benefits of digital document management systems. If issues get ignored before the transition to a more compliant system, the legacy system’s inefficiencies will transfer over to the new system. Even though there could be initial resistance to switch to such a controlled system, the long-term benefits will outweigh the short-term user adaption issue. Being prepared and setting an expectation of what the change will be like and the type of issues to expect will be the first step to help users understand that the changeover may feel difficult at first but ultimately will help them be more successful.

Companies, therefore, require a digital system that demonstrates both regulatory and functional electronic signature compliance. A system that

  • helps in customizing levels of authentication
  • provides scalability and flexibility to customize workflows
  • supports bulk approval of all artifacts which are duly reviewed and signed off from a regulatory perspective
  • supports test management processes such as test plan, test lab, etc.
  • provides detailed audit trails for stakeholders and regulatory organizations.

Figure: 2Microsoft Dynamics 365 Finance and Operations – Quality control transaction with digital signatures

Microsoft Dynamics 365 Finance and Operations

Below are some common requirements for electronic signature within a Pharmaceutical ERP system:

  1. 1.The employee should have the appropriate security role in the system to create an electronic signature.
  2. 2.The employee has to be individually recognized by the system with their signature.
  3. 3.The employee should have a certificate on the system that is used to generate the electronic signature.
  4. 4.The signature should be able to detect if there were any susceptible violations.
  5. 5.If a signature violation occurs, it should be easily audited.

Electronic signatures can be possible with different levels of security, which allows you to verify a user, data and attest a signature on certain set processes. Only those individuals with access to view the transactions and have the ability to sign off electronically will be able to create the signature. The system will have a log to track the individual, the associated transaction event, date and time of the signature.

Microsoft Dynamics 365 Finance and Operations (F&O) is a CFR 21 Part 11 compliant system that gives you the ability to record an electronic signature on different Quality-driven transactions. F&O maintains the necessary audits of approvers authorized with a secure certificate from the system. The certificate provides you with an encrypted key using a password only accessible to the user. The system allows users only with the appropriate security credentials to access the transactions and once all the verification is done, lets the authorized personnel create a signature on the transaction.

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