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Quality Management

Understanding the Basics of Quality Management Systems
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Understanding the Basics of Quality Management Systems (QMS)
Understanding the Basics of Quality Management Systems (QMS) 750 501 Xcelpros Team

Introduction to QMS

In our last post, we talked about the main principles of TQM, or Total Quality Management, which serve as the groundwork for modern Quality Management Systems (QMS). Today, Quality Management Systems have become the norm, often completely replacing the traditional Total Quality Management approach. The TQM process shares some common goals with QMS, but there are some distinct underlying principles.

Modern organizations have evolving needs, and a modern QMS prioritizes newer principles, such as organizational agility and transparency. QMS content and design also vary based on specific business requirements. While the components of a QMS may vary widely from organization to organization, there are some key elements which remain essential to any effective system.

Simply put, a QMS is a set of policies, procedures, and processes required to plan and execute an area of business. These systems influence an organization’s ability to meet customer needs and regulatory requirements. Therefore, an effective QMS focuses on streamlining processes, reducing errors, and increasing customer satisfaction.

Structures of Quality Management Systems

While the exact structure of a QMS can differ between organizations, certain standards must be met for it to be considered a true QMS. ISO 9001:2015 is the international standard for quality management systems (QMS), and it outlines requirements for organizations to establish, implement, maintain, and continually improve a Quality Management System.

The key requirements for a QMS, according to ISO 9001:2015, include:

  1. 1. Scope
    1. a. Define the scope of the QMS, including the products, services, and processes it covers.
  2. 2. Normative References
    1. a. Identify relevant standards and documents used as references for implementing the QMS.
  3. 3. Terms and Definitions
    1. a. Provide clear definitions of terms used within the QMS.
  4. 4. Context of the Organization
    1. a. Understand the internal and external factors that can impact the organization’s ability to achieve its objectives.
    2. b. Identify interested parties and their requirements.
  5. 5. Leadership
    1. a. Top management’s commitment to the QMS.
    2. b. Establish a quality policy and communicate it.
    3. c. Assign roles and responsibilities within the organization.
  6. 6. Planning
    1. a. Set quality objectives in line with the organization’s goals.
    2. b. Develop plans to achieve those objectives.
  7. 7. Support
    1. a. Provide necessary resources for the QMS.
    2. b. Ensure competent personnel.
    3. c. Establish communication processes.
    4. d. Manage documented information (policies, procedures, records).
  8. 8. Operation
    1. a. Plan and control operational processes.
    2. b. Establish controls for product/service requirements.
    3. c. Determine criteria for monitoring and measurement.
    4. d. Implement processes to address risks and opportunities.
  9. 9. Performance Evaluation
    1. a. Monitor, measure, analyze, and evaluate the QMS.
    2. b. Assess customer satisfaction.
    3. c. Conduct internal audits and management reviews.
  10. 10. Improvement
    1. a. Continually improve the effectiveness of the QMS.
    2. b. Correct nonconformities and take corrective/preventive actions.
    3. c. Enhance processes based on evaluation and analysis.

Figure 1:Key Features of a Quality Management System based on ISO:9001

Key Features of a Quality Management System based on ISO:9001

Revolutionizing Quality Management

Nowadays, advanced software and modern tools continue to saturate every facet of the business world. It should come as no surprise then, that more quality management / quality assurance professionals are pushing for the newest wave of QMS software solutions. Taking this approach enables them to optimize their business processes, elevating their performance to new heights. According to Harvard Business Review, companies with highly developed Quality Management Systems spend, on average, $350m less annually fixing internal mistakes than companies with poorly developed Quality Management Systems.

Implementing a Quality Management System (QMS) requires a strategic approach and commitment from all levels of an organization. An article from McKinsey states, “Quality is a value-added partner and coach that helps integrate compliance into regular operations while enabling speed and effectiveness.” With the right implementation partner, a QMS can significantly contribute to a company’s success- they are essential tools for enhancing customer satisfaction, increasing operational efficiency, and ensuring compliance with regulations.

However, these systems are not a one-size-fits-all solution; ideally, a QMS is tailored to the specific needs and circumstances of the organization it is designed for. By incorporating essential components and features for the specific business, developing an effective solution becomes a more straightforward operation.

Integrated QMS Solutions for Dynamics 365

As a Microsoft Cloud Solution Provider (CSP), XcelPros provides implementations, services, and licensing for Microsoft products. To ensure we continue providing the best possible services for our customers, we regularly review our implementations of Dynamics 365 Finance and Supply Chain Management. Over time, we recognized a trend in the growing need for QMS features which integrate directly with Dynamics, as we found most of our customers were stuck using third-party QMS solutions. This was especially true of clients in highly regulated industries, including pharmaceuticals, chemicals, medical devices, and manufacturing (CMO, CRO).

In response to these findings, we developed our own line of QMS solutions that integrate fully with Microsoft Dynamics 365, eliminating the need for third-party solutions (not only pricey, but also not very user-friendly). First, Integrated Quality Management, or iQM, makes it easy to manage complaints, CAPA, and deviations centrally within Dynamics. Integrated SOP Management (iSM) offers comprehensive functionality for authoring, maintaining, and distributing Standard Operating Procedures (SOPs). Finally, with chemical and pharmaceutical companies in mind, we created Integrated Chemical Management. iCM offers complete functionality for SDS management, label management, and DEA customer management.

For companies without a system in place for managing complaints, deviations, and/or corrective actions and preventative actions (CAPA), iQM may be the perfect solution for you. Companies who are managing labels or safety data sheets (SDS) manually or need a better system for DEA customer management will find that iCM is just the solution you have been looking for. If you don’t yet have a way to manage internal SOPs digitally, Integrated SOP Management (iSM) offers everything you need. These products work great individually, or you can choose to bundle them all into a convenient package for maximum benefit.

Final Thoughts on Quality Management Systems

Your business may already have a solution in place for managing SOPs, labels and SDS, complaints, deviations, or any of the other features mentioned above. If that’s the case, is your QMS setup for managing those issues digitally and integrated with your organizational software?

Until now, even if you were using Microsoft Dynamics 365 as your ERP, it’s unlikely that your QMS was seamlessly integrated. Chances are, your QMS is a separate system, held together by an aging string of code that’s almost as old as your organization. Or, perhaps you are still using manual processes (which is more common than you may think). Whatever the circumstances may be, XcelPros can help make your processes more efficient. Modernizing products and processes is the best way to stay in compliance with any regulatory standards your business may be held to, and to keep customers coming back for reliable, consistent, and high-quality products.

Stay tuned for our next post, which will provide more detail about XcelPros’ QMS applications and how they can help your company.

If you are ready to put a new QMS into place now, there’s no reason to delay – Schedule Demo

The Key Principles of Total Quality Management
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The Key Principles of Total Quality Management (TQM)
The Key Principles of Total Quality Management (TQM) 700 525 Xcelpros Team

Introduction to Total Quality Management (TQM)

Total quality management is a strategic, customer-focused approach to improving businesses through customer satisfaction. The idea of Total Quality Management, or TQM, came to life in the 1950s but didn’t gain significant traction till the early 1980s. It laid the groundwork for many modern methodologies we see today, such as Six Sigma and Lean. Additionally, principles found in the ISO 9001, the globally recognized Quality Management System (QMS) standard, can also be attributed to the development of TQM.

The significance of Total Quality Management lies in its ability to offer a flexible framework for implementing efficient productivity and quality initiatives to improve customer satisfaction across all business operations. Implementing TQM isn’t a one-time process, but a systematic approach to find and eliminate all forms of waste and inefficiency in a company’s operations and guide the focus towards customer needs and satisfaction.

This article will guide you through the key principles of total quality management and how to utilize them successfully within your organization.

The 8 Key Principles of Total Quality Management

Figure 1:The 8 Principles of Total Quality Management (TQM)

The 8 Principles of Total Quality Management

Principle 1: Customer-Focused

Principle 1, Part I: Understanding Customer Needs

  • Conducting market research to understand the needs and wants of the customers
  • Creating products or services that meet or exceed customer expectations
  • Regularly collecting customer feedback and using it to improve products or services

Principle 1, Part II: Customer Satisfaction

  • Providing high-quality products or services that satisfy customer needs
  • Offering excellent customer service and support
  • Building strong relationships with customers to increase their loyalty

Principle 2: Total Employee Involvement

  • Encouraging all employees to participate in improving processes, products, and services
  • Providing training and development opportunities to all employees
  • Recognizing and rewarding employees for their contributions to the improvement efforts

Principle 3: Process-Centered

  • Identifying key processes and improving them continuously
  • Using statistical data to measure and analyze the performance of the processes
  • Implementing new processes or modifying existing ones to achieve better results

Principle 4: Integrated System

  • Developing a system that integrates all the activities and processes of the organization
  • Ensuring that all the parts of the system work together effectively and efficiently
  • Continuously monitoring and adjusting the system to improve its performance

Principle 5: Strategic and Systematic Approach

  • Developing a strategic plan that aligns with the organization’s mission, vision, and goals
  • Implementing the plan systematically and monitoring its progress regularly
  • Making necessary adjustments to the plan based on the results of the monitoring

Principle 6: Continual Improvement

  • Making continual improvement a part of the organization’s culture
  • Encouraging all employees to look for ways to improve their work processes
  • Regularly reviewing and improving the organization’s systems, processes, and performance

Principle 7: Fact-Based Decision Making

  • Making decisions based on factual data and analysis, not on assumptions or guesses
  • Collecting and analyzing data regularly to support decision-making
  • Using statistical methods to identify trends, problems, and opportunities for improvement

Principle 8: Communications

  • Communicating the organization’s mission, vision, goals, and plans to all employees
  • Encouraging open and honest communication among all levels of the organization
  • Providing regular updates on the progress of the improvement efforts

The eight TQM principles provide a framework for improving an organization’s performance by focusing on customer satisfaction, employee involvement, process improvement, and fact-based decision-making. Implementing these principles is a good way for organizations to increase their competitiveness and achieve their strategic goals.

Total Quality Management – Conclusion

The way we do business has changed significantly over the last few years. This has left a lasting impact on business requirements for quality management, compliance, and regulatory standards. While Total Quality Management (TQM) has always been a major factor, new terms, concepts, and methods for quality management are capturing our attention and shaping the way we think about quality.

Next time, we will explore a new method which commonly comes in the form of a business intelligence platform, the Quality Management System (QMS). We will discuss exactly what a Quality Management System is and how QMS’ are completely replacing TQM in some organizations.

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Also read: Quality Management and Control – Best Practices (xcelpros.com)

CAPA vs Non-Conformances: Key Differences in Quality Management
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CAPA vs. Non-Conformances: Key Differences in Quality Management
CAPA vs. Non-Conformances: Key Differences in Quality Management 700 500 Xcelpros Team

For our partner industries, quality management has become crucial to ensure products and processes meet customer requirements and regulatory standards. Corrective and Preventive Actions (CAPA) and non-conformances are two essential concepts for quality management. They are often used interchangeably, but actually have some distinct differences. In this article, we explore the key differences between CAPA and non-conformances, their scope, documentation requirements, and severity. A good understanding of the differences between these concepts can give organizations a better opportunity to implement effective quality management practices, preventing issues and ensuring customer satisfaction.

Concepts, Defined

Non-Conformance:

Non-conformance is a term used to describe any instance where a product or process does not meet specified requirements or standards. It indicates that something has gone wrong or deviated from the expected outcome. Non-conformances can occur in any phase of the product lifecycle, from design to production and distribution.

When a non-conformance is identified, it must be addressed to prevent its recurrence. This may involve reworking the product, taking corrective action to fix the issue, or stopping production altogether. In some cases, a non-conformance can be considered acceptable if it does not affect the product’s safety, quality, or functionality.

Corrective and Preventive Actions (CAPA):

On the other hand, CAPA is a more proactive approach to quality management. Corrective and Preventive Actions involve identifying the root cause of a problem and implementing measures to prevent it from happening again. It is a systematic and structured process that can includes things such as:

  • We are identifying and documenting the problem or non-conformance.
  • We are investigating the root cause of the problem.
  • We are developing and implementing corrective actions to address the immediate issue.
  • We are developing and implementing preventive actions to prevent recurrence of the issue.

This process of continuous improvement aims to identify and eliminate the underlying causes of problems, rather than just addressing the symptoms. It is a critical component of many quality management systems, such as the QMS principles defined by ISO 9001, ensuring that products and processes meet customer requirements and comply with regulatory standards.

According to a report by the American Society for Quality, organizations that use CAPA report higher levels of customer satisfaction, with 84% of respondents reporting that their CAPA processes led to improved customer satisfaction.

Key Differences Between CAPA and Non-Conformances:

Reactive vs. Proactive Approach:

Non-conformances are reactive in nature and focus on fixing a problem that has already occurred. CAPA, on the other hand, is a proactive approach that aims to prevent problems from occurring in the first place.

Scope:

Non-conformances are usually specific to a particular product or process, while CAPA has a broader scope that encompasses the entire quality management system.

Documentation:

Non-conformances are usually documented in a non-conformance report, while CAPA requires more extensive documentation, including investigation reports, corrective action plans, and preventive action plans.

Severity:

Non-conformances may be minor or significant, depending on their impact on the product or process. CAPA, however, is typically reserved for critical issues that have the potential to cause substantial harm or result in a significant recall.

Companies should not use non-conformances instead of CAPA, as both concepts serve different purposes in quality management. Non-conformances are reactive and focus on fixing a problem that has already occurred, while CAPA takes a proactive approach and aims to prevent problems from occurring in the first place.

Using only non-conformances would mean that an organization is only addressing the immediate issues as they arise, without taking steps to prevent similar problems from happening in the future. This could result in more cases and increased costs for reworking, fixing, or recalling products.

CAPA, on the other hand, is a more comprehensive approach that addresses immediate issues and aims to prevent their recurrence through root cause analysis and implementation of preventive measures. Implementing CAPA can help organizations improve their quality management system and reduce the risk of future non-conformances, leading to improved customer satisfaction and lower costs.

Really, companies should use both non-conformances and CAPA in their quality management system to ensure that they’re addressing both immediate and long-term issues and continuously improving their processes.

Use Cases: Failure to Implement Effective CAPA Processes

Here are a few examples of companies that faced quality management issues when they did not use CAPA and relied only on non-conformances:

Johnson & Johnson:

In 2010, Johnson & Johnson’s subsidiary, DePuy Orthopedics, recalled two hip implant models due to high failure rates. The company had only used non-conformance reports to address the issue but failed to implement CAPA processes to identify and address the root causes of the problem. As a result, the issue persisted for several years and led to costly lawsuits and damage to the company’s reputation.

Volkswagen:

In 2015, Volkswagen was found to have cheated on emissions tests by installing software in its diesel engines that could detect when the car was being tested and reduce emissions accordingly. The company initially used non-conformance reports to address the issue but failed to implement effective CAPA processes to prevent the issue from recurring. As a result, the company faced significant financial losses, damage to its reputation, and legal challenges.

Boeing:

In 2018, Boeing’s 737 Max airplane was involved in two deadly crashes that were linked to a software issue. The company had initially used non-conformance reports to address the issue but failed to implement effective CAPA processes to identify and address the problem’s root causes. As a result, the issue persisted, leading to significant financial losses, damage to the company’s reputation, and regulatory scrutiny

These use cases highlight the importance of implementing effective CAPA processes in quality management to prevent recurring issues and ensure compliance with regulatory requirements.

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Implementing a Corrective and Preventive Action (CAPA) System with Non-Conformances

To implement an effective CAPA system and address non-conformances, the first step is analyzing your current quality management system to identify areas for improvement.

  • Create a comprehensive CAPA plan outlining steps for corrective action and preventing future non-conformances.
  • Train employees on the CAPA system and their role in reporting non-conformances, establish a process for tracking and monitoring CAPA activities, and encourage a culture of continuous improvement.
  • Regularly communicate progress to stakeholders and conduct audits to ensure quality standards and regulations compliance.
  • Use performance metrics to identify trends and areas for improvement and make informed decisions about future process enhancements.

Following these steps, you can improve your quality management system and ensure your organization operates more efficiently and effectively.

Several key stakeholders would be impacted by the implementation of a CAPA system and the management of non-conformances. These include:

  • Customers: Customers may be impacted by non-conformance in the products or services they receive. A robust CAPA system can identify and resolve any issues quickly, improving customer satisfaction and loyalty.
  • Employees: Employees involved in the production or delivery of products or services may be impacted by non-conformance. A well-implemented CAPA system can help prevent these issues and improve overall quality, reducing the workload and stress on employees.
  • Management: Management teams oversee the quality of products and services and ensure compliance with regulations and standards. Effective CAPA management can ensure these responsibilities are met and provide valuable data for making informed decisions.
  • Regulators: Regulatory bodies may be interested in the CAPA system and non-conformance management processes to ensure industry standards and regulations compliance.
  • Shareholders: Shareholders may be impacted by non-conformance if they result in financial losses or damage to the company’s reputation. An effective CAPA system can help to prevent these issues and maintain the company’s financial health and reputation.

Conclusion

Quality management is critical to ensuring customer satisfaction and compliance with regulatory standards. Non-conformances and CAPA are essential concepts in quality management with distinct differences in approach, scope, documentation, and severity.

While non-conformances focus on addressing immediate issues, CAPA takes a proactive approach to prevent problems from occurring in the first place. Companies that rely solely on non-conformances without implementing effective CAPA processes risk facing significant financial losses, damage to reputation, and legal challenges.

In the future, organizations must use non-conformances and CAPA in their quality management systems to address immediate and long-term issues continuously and improve their processes. When you understand the differences, your organization can implement effective quality management practices that prevent problems and ensure customer satisfaction.

The importance of pharmacovigilance during a pandemic banner
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The Importance of Pharmacovigilance During a Pandemic
The Importance of Pharmacovigilance During a Pandemic 700 500 Xcelpros Team

At a Glance

  • The World Health Organization (WHO) emphasizes providing the most effective drugs that do not cause severe adverse effects.
  • Understand adverse effects and how to prevent them by assessing the right chemicals, quantities and processes in medical vaccine manufacturing.
  • Digital solutions and services are designed to help scientists and pharmaceutical company decision-makers detect, assess, understand and prevent adverse effects from their medicines.
  • Starting now, pharmaceutical companies are placing a greater emphasis on drug quality checks to avoid mistakes caused by rushing the production process.

Introduction

Today, most people are familiar with terms like “clinical trials,” “safety assessment tests for vaccines” and “FDA approvals” because of COVID-19 media coverage over the last few years. While these terms have always been a part of any pharma and biotech manufacturing companies’ quality assurance program, the ongoing pandemic has made them part of everyday conversation.

People often wonder why it takes so long for a drug or vaccine to get approved for mass use, and rightfully so. The answer however, lies in the principles of pharmacovigilance, also known as drug quality control.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Source: The World Health Organization

The Primary Goals of Pharmacovigilance Guidelines

The goals of a typical pharmaceutical quality control program include:

  • Assessing a drug’s short-term and long-term adverse effects and any harm the drug might cause a patient.
  • Continuously collating and monitoring a particular drug’s safety data.
  • Assessing the risks and rewards of the drug to make a guided decision on the administration of the drug.
  • Communicating adverse drug reactions (ADRs) data between health professionals and clinical researchers while maintaining transparency at all levels.
  • Preventing the distribution and administration of unsafe drugs by medical bodies and drug companies.

All pharmaceutical companies require a team of professionals to carry on this constant quality check of their drugs. This team can include scientists, clinicians, biochemists, physicians and medical writers. The team’s job is to collect, collate, analyze and assess the safety profile of every drug.

This task requires constant alertness and unprecedented agility for an accurate and quick response. In today’s market, manual data reviews are no longer adequate. Combining finely tuned digital tools and well-trained employees is the best way to protect patients from severe injury or death.

A drug maker’s automated quality control program should be smart enough to help collect, analyze and check data. The software equipped with artificial intelligence can check a drug’s composition, verify safety profile mapping and perform other crucial steps required for necessary quality checks.

Pharmaceutical companies need to follow a wide range of procedures to ensure their pharmacovigilance is up to government and industry standards in order to remain compliant.

“The scope of the problem of poor-quality drugs transcends national borders because the manufacturing and supply chain of medical products thrives in an international market.” Elizabeth Ndichu, MD, and Kevin Schulman, MD

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To comply with new quality standards and still meet today’s demands for fast-track drug development and clinical trials, pharmaceutical and biotechnology firms need to strictly adhere to the process of end-to-end pharmacovigilance.

  • Carrying out detailed patient surveys for different age groups, countries and health conditions
  • Using consultants and experts to manage its quality control program
  • Using software such as Microsoft Dynamics 365 for the pharmaceutical industry to help ensure error-free data maintenance, analysis and report generation
  • Keeping all stakeholders in loop at all times to avoid any errors
  • Maintaining records of their quality control policies and procedures. These records are required for medicines plus other products such as cosmetics, nutritional supplements and dietary products
  • Formulating a plan for intervention, mitigation, assessment and resolution in the event of drug quality issues

Figure 1:Digital Ecosystem: Pharmacovigilance

Digital Ecosystem: Pharmacovigilance

Pharmaceutical companies need to take an agile approach toward pharmacovigilance. Leveraging technology for streamlining safety procedures and quality checks is no longer a matter of convenience but a necessity.

Solutions like Microsoft Dynamics 365 Finance and Supply Chain Management provide Quality Control functionality. Each of these computer programs has methods to collect, track and report quality test results. This software is a comprehensive solution that makes it easy to leverage technology to streamline quality check operations.

These solutions can pave the way towards regulatory compliance, stringent component mapping and monitoring of a drug’s safety profile. It reduces manual intervention by employees, allowing individual case safety reports (ICSRs) to be performed easily.

Microsoft Dynamics modules can be used by different departments by the likes of clinical researchers, scientists, medical writers, physicians, medical representatives and government drug governing bodies. These solutions for monitoring drug safety are considered one of the best investments a company can make today.

Key Takeaways

  • Technologically-enhanced pharmacovigilance is the need of the hour for today’s pharmaceutical companies.
  • The pharmaceutical sector continues to evolve on a large scale. This change requires gathering medicinal data at a global level to map drug safety.
  • Forming a blueprint to follow the pharmacological journey is a critical step for any pharma and biotech company.

References: Pharmacovigilance: Regulation and Prequalification

Best Practices in Quality Management and Control
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Quality Management and Control – Best Practices
Quality Management and Control – Best Practices 700 500 Xcelpros Team

Introduction to Quality Management and Control

Reducing the amount of defective products saves manufacturers money. Cutting raw materials waste, using labor and equipment more efficiently, and reducing returns from unhappy customers are all ways to save money when product defects are reduced. Boosting quality control in manufacturing can also lead to an enhanced customer experience, supercharging your brand while lowering the need for extra raw materials to replace anything wasted.

Three ways any industry can improve quality control include:

  1. 1. Reducing human mistakes by automating repetitive actions. Automation also improves accuracy and increases visibility. Combined with internet of things (IoT) sensors, automation creates data that can be analyzed for hidden incremental improvements.
  2. 2. Inspecting, testing, and comparing products to defined standards. Products that meet those standards are shipped. Those that don’t are recycled. Adding computerized sensors in the inspection and quality control phase also provides an opportunity for insights into ways to create and build quality control standard operating procedures (SOPs).
  3. 3. Tracking inventory from the material supplier through warehouses and production to the end customer’s door. Accurate labeling lets manufacturers trace everything from essential ingredients to sub-assemblies and completed products. Using barcodes combined with automated and hand-held scanners provides a third data entry point into your firm’s network, ensuring most of what goes in comes out as salable products.

Using these three quality control methods in production can help your company create an efficient production cycle that reduces machine downtime, defects, and waste rework. The result is better merchandise and less waste, benefiting customers and manufacturers alike.

Quality Control Starts with Quality Planning

For many, focusing on quality control, or QC, means creating an efficient, consistent manufacturing process that gives the same results every time the process is repeated. The only way to ensure this consistency is with a well-formulated quality plan.

As a manufacturer or company who uses contract manufacturers, you likely focus on two critical elements: quality and cost. The best way to deliver the highest quality at the lowest cost is to start with quality planning. The American Society for Quality defines quality plans as “a document or set of documents that describe the standards, quality practices, resources and processes pertinent to a specific product, service or project.”

A quality plan for manufacturing ensures:

  • Conformance to your customer’s requirements, which may include meeting government standards.
  • Verification of your own standards while confirming your internal procedures work as expected.
  • Tracking the motions of every product, from the moment raw materials or sub-assemblies enter your premises, to their delivery at your customer’s door.
  • Consistent results via ensuring the quality methods in production work as designed and as expected.
  • Deficiencies in worker training are identified, allowing them to be corrected.
  • Insights into ways to further enhance your quality control standard operating procedures (SOPs).

The major components of a quality plan which must be stated and defined:

  • Responsibility for distribution, in terms of which manager or department confirms each step in the process so the end result aligns with the company’s goals.
  • Process steps and individual procedures for each step in the overall production process.
  • Testing requirements and the amount of government oversight vary by industry. For example, medicines or chemicals have significantly more regulations to comply with than furniture, for example.
  • Methods for tracking changes and modifications, regardless of the cause.
  • Quality process measurement in terms of value provided by the quality plan.

The final and most essential components of a quality plan are standards: What practices and procedures must be followed in your quality plan so that manufacturing meets requirements, customer’s needs, and government compliance requirements?

The Value of Standard Operating Procedures (SOPs)

A key part of quality control in manufacturing is having standard operating procedures (SOPs) that are easily replicated. Each step in each procedure making up the entire production process is checked, re-checked, and confirmed by those designated to follow that specific SOP. The final test is completed by having a new hire follow said procedure and reviewing their results. When the results from a new hire are able to meet set production quality control standards, the SOP can be considered a success. When the results do not meet set production quality control standards, the fault lies with the SOP document, not the worker.

According to the U.S. National Library of Medicine at the National Institute of Health, Standard Operating Procedures (SOPs) create a structured approach to work and guarantee consistent execution of tasks by all individuals involved. Well-crafted SOPs play a critical role in maintaining Good Clinical Practice (GCP), preventing errors, reducing waste, and avoiding unnecessary rework. On the other hand, poorly articulated SOPs can lead to misinformation and confusion.

These documents must be user-friendly and written in a way that is easy to follow and leaves little room for errors. Preventing errors via SOPs improves quality, reduces waste, and when written with input from people involved in the actual manufacturing process, boosts efficiency.

The Role of Quality Assurance

In manufacturing, quality assurance (QA) encompasses the practices that manufacturers employ within a quality management system to uphold expected levels of consistent quality for the items they create.

When paired with quality control, quality assurance works to ensure customers receive products that meet specific standards, in terms of defects and tolerances. QA is a proactive method that works via employee training, defining processes in written SOPs, and selecting the right tools for each job. QC looks at the results from QA and determines if a product passes or fails.

Effective quality control and quality assurance plans, combined with quality auditors ensuring standards are met, results in cost savings, boosted efficiency, and boosted customer satisfaction.

Figure 1: The Role of Quality Assurance

The Role of Quality Assurance is to boost customer satisfaction and efficiency and provide cost savings.

The Role of Quality Assurance

  • Cost savings in terms reduced waste
  • Using equipment more effectively boosts efficiency

Quality management standards vary by the industry, though one of the most common is ISO 9000. A set of international quality standards, ISO 9000 covers many different industries and approaches.

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Quality Management Systems

A Quality Management System (QMS) is a structured framework that captures the essence of how things get done right. It’s all about documenting processes, procedures, and responsibilities, with the ultimate goal of achieving quality policies and objectives. By coordinating and directing an organization’s activities, the QMS plays a vital role in meeting customer needs, fulfilling regulatory requirements, and always striving to be better, faster, and more efficient.

An effective QMS helps manufacturing companies:

  • Define production processes
  • Reduce waste
  • Prevent mistakes
  • Lower costs
  • Engage staff
  • Set an organization-wide direction
  • Communicate a readiness to customers that it wants to produce consistent results

In today’s digital world, QMS doesn’t stand alone in a silo: it’s part of a company’s overarching software linking QA and QC to inventory, sales and other departments. One example of a versatile QMS is called Integrated Chemical Management (iCM), which integrates fully with Microsoft’s flagship enterprise resource planning (ERP) solutions Microsoft Dynamics 365 Finance, Supply Chain Management, and Business Central. When integrated with Dynamics 365, iCM  provides a scalable, easy to use overarching quality management tool that helps with on time delivery (OTD) for products, under budget.

When merged with internet of things (IoT) sensors on production machines, Integrated Chemical Management (iCM) and Dynamics 365 manage and massage data. Among the results are ways to make incremental quality improvements that boost long-term overall quality scores, resulting in more sales and customer satisfaction.

Summary – Quality Management

For any company, producing higher-quality products takes forethought, patience, and serious effort. This means having a documented quality management plans that include step-by-step directions for every procedure and every part of the production process.

When it comes to manufacturing, an effective quality management plan looks at quality assurance and quality control, examining and testing various stages of the production process to ensure everything meets your demanding standards, boost efficiency, and reduce wasteful practices.

Helping measure these results is a modern quality management system like Integrated Quality Management (iQM) from XcelPros, which integrates fully with Microsoft Dynamics 365 Finance and Supply Chain Management. When used as part of an overall ERP software plan, iQM helps companies find ways to improve quality while reducing costs. This leads to an overall effect is a boost in profitability, helping power additional growth and granting ROI.

Taking the time to plan how to function in these uncertain times is essential. Using software tools such as Microsoft Dynamics 365 Finance, Supply Chain Management, or Business Central will help companies continue to operate successfully in rapidly changing conditions.

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Also read: The Key Principles of Total Quality Management (TQM)

Challenges in Pharmaceutical Supply Chain due to Covid-19
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Pharmaceutical Supply Chain Challenges due to Covid-19
Pharmaceutical Supply Chain Challenges due to Covid-19 700 500 Xcelpros Team

Introduction

Even while the United States and much of the world continues to vaccinate and protect its citizens from COVID-19, new variants of the disease continue to pop up around the world. Since its arrival, not only have millions of lives been lost and affected, problems caused by the disease continue to wreak havoc on the pharmaceutical supply chain.

As of May 2021, Google states nearly 3.4 million dead in 220 countries and territories worldwide, including over 587,000 in the US alone

Some of the more prominent short-term effects cited in a July, 2020 article on Springer include

  • Demand changes leading to shortages caused by panic-buying oral home-care medications
  • Supply shortages of active pharmaceutical ingredients (APIs) and finished products, especially those coming from China and India
  • Shifting communications and promotions to telecommunication and tele-health, resulting in a 70 – 80 percent drop in visits to physician offices and clinics
  • Change in the focus of research and development programs to dealing with COVID-19

More Long-lasting effects include:

  • Delayed approvals for non COVID-related pharmaceutical products, partially caused by the closure or semi-closure of regulatory agencies
  • Self-sufficiency and lower demand for APIs and finished products made in China and India caused by delays in manufacturing and disruption to shipping and logistics
  • Organization growth impacted by economic slow-downs around the globe
  • Ethical issues from poorly researched clinical therapies and products
  • Drastic change in consumer use of cleaning and health products

By the Numbers

  • 2x increase in investigational treatments in the U.S.
  • 100% – 700% increase in the use of medicines to treat COVID-19 in U.S. hospitals (January-July 2020)
  • Upwards of 24 million excess prescriptions have been written in the U.S. alone, for things like hypertension, mental health issues, respiratory problems, diabetes, and anxiety.
  • 156 clinical trials for COVID-19 in the Middle East and 140 in the EU
  • 70%-80% reduction in patient visits to doctors’ offices in the EU
  • 23% of patient interactions in the EU are now being done online

Source: Springer.com

Supply Chain Effects

A recent report by Deloitte about the impact of COVID on the pharmaceutical industry includes a look at Supply Chain Management. The report cites a number of key risks to be aware of in different functional areas, including the following

Procurement

  • Quality checks of received materials. Mitigation measures include increasing warehouse space for quarantining shipments from China.
  • Shortages of raw materials, APIs and solvents due to dependency, inadequate materials to complete BOMS/batch size processing. Prevented by boosting stocks of critical inventory, evaluating alternate sourcing of impacted materials and using government support policies when looking at investments in production plants.
  • Shutdowns of vendor plants. Solved only by identifying shutdowns from remote (i.e., Asian) sources and pressure testing supply chains for various scenarios.

Planning

  • Expiration of materials and monitoring for reassessments and quality certificates where the solution is submitting studies to the FDA with the longest agreeable expiration date.
  • Shutdowns from contract manufacturers, requiring sufficient communication regarding their ability to deliver products.
  • Additional quality control checks for contamination issues. This can be mitigated by having quality control personnel on-site and thorough sanitizing of all in-bound products, employees and equipment.
  • Contamination after final packaging. Requiring the disinfecting of shipments before delivery, possibly with photographic proof.

Transportation and logistics

  • Non-availability of local transportation to move raw materials and finished goods. Can be solved by locating alternate partners and getting approval to move essential drugs should a lockdown occur.
  • Contamination issues related to transportation or vehicles. Requires the disinfecting of all vehicles, plans for properly storing temperature-sensitive products in assigned warehouse space.

Export

  • Contractual compliance. This can be mitigated by ensuring the person collecting the order is aware of any regulatory restrictions.
  • Contractual terms with domestic and export customers. Preventing this requires seeking advice from insurance brokers and engaging early with clients to determine what could work if supply chain or personnel issues occur.

Figure: 1Pharmaceutical Supply Chain Areas Affected by Covid-19

Supply Chain Effects

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Lasting Effects

The effects from COVID have caused businesses to do whatever necessary to stay competitive, such as the repurposing of disposable components from single use systems to use in COVID-specific programs at the expense of other critical efforts. This is just one of the continuing effects on the supply chain cited by Contract Pharma in a recent COVID-19 Impact Report, as well as the following pointed out by other executives in the industry.

  • Kay Schmidt of Catalent said finding vaccines and target therapies for Covid-19 has boosted demand for their services. The increased demand, “has led to greater collaboration and innovation between partners, regulators and throughout supply chains to meet key milestones”. This boost to business requires additional planning and communication to ensure resource allocation for multiple programs.
  • James Rogers of Sterling said, “The impact of the global pandemic has exposed the fragility of the pharmaceutical supply chain.” He predicts that supply chain resilience and reliability will be given the same importance as price when developing future supply strategies.
  • Danita Broyles of U.S. Pharmacopeia is quoted by Contract Pharma as saying, “the decrease in on-site inspections has the potential to increase quality risks to the global supply chain,” adding pressure to manufacturers and suppliers to ensure the quality of their products.
  • Ben Wylie of ChargePoint Technology said that, “many governments are now pushing the industry to rethink its model to safeguard drug production.” He cited a program in India to reduce reliance on China for critical drugs and APIs.

Final Thoughts: The Impact of COVID-19 on Regulatory Practices

COVID-19 will continue to have an ongoing impact on regulations in the areas of clinical study trial design, clinical trial study development and post-clinical trial regulatory submissions, Dr. Ronan Brown of IQVIA wrote in an article on European Pharmaceutical Review.

Among the changes forced on drug manufacturers includes a more decentralized approach to collecting patient information and rapid access to regulators, Dr. Brown said. This includes pre-investigational new drug meetings with the FDA now granted in less than 30 days. The FDA has also taken steps to accelerate the review and start of new studies.

Flagging potential obstacles and safety concerns during these early meetings lets pharmaceutical companies move faster into human trials, he explained.

Decentralized clinical trials, which he expects will ultimately cost about the same as the traditional versions, will offer greater diversity in terms of patient cohorts along with increased mobility and convenience.

mistakes that slow the growth of a chemical manufacturing company
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Mistakes that slow the growth of a chemical company
Mistakes that slow the growth of a chemical company 700 500 Xcelpros Team

7 Quotes

Companies need to grow if they wish to flourish and prosper. There are many quotes already related to business growth you might have heard before, including:

  • “Conformity is the jailer of freedom and the enemy of growth,” President John F. Kennedy
  • When you stop growing, you start dying,” author William S. Burroughs
  • “Every problem is a gift —without problems we would not grow,” motivational speaker and author Anthony Robbins
  • “Out of your vulnerabilities will come your strength,” neurologist Sigmund Freud
  • “Strength and growth come only through continuous effort and struggle,” author Napoleon Hill
  • “The only way you are going to have success is to have lots of failures first,” Google co-founder Sergey Brin
  • “The journey of a thousand miles begins with a single step,” Chinese philosopher Lao Tzu

Introduction

What do you consider growth for your business? How this is measured is up to each individual organization. Data points that highlight company growth includes:

  • Sales
  • Revenue
  • Profits
  • Company Value
  • Number of customers
  • Number of Employees

The next question to ask is, “Are you growing in a way that is sustainable and lets you achieve all of your company’s goals?” As they grow, companies can make several mistakes that doom their opportunities for growth.

According to Growthink, the most common growth-related mistakes are:

  1. 1.Ignoring the Ansoff Matrix—also known as the Product/Market Expansion Grid—that details ways to increase sales.

Figure: 1Ansoff Matrix: Product-Market Expansion Grid

Ansoff Matrix: Product-Market Expansion Grid

  1. 2.Failing to conduct market research, such as a SWAT (strengths, weaknesses, opportunities and threats) assessment.
  2. 3.Developing weak financial models showing the impact of each growth opportunity.
  3. 4.Forgetting what worked in the past for your company.
  4. 5.Starting at the wrong place and lacking a clear vision of where you want to go.
  5. 6.Lacking focus, which can occur when a company lacks a clear growth plan.
  6. 7.Ignoring the human factor by not having the right people.

Chemical Industry Mistakes

The previous items apply to all companies wanting to grow, regardless of industry. The heavily regulated pharmaceutical and chemical industries face additional challenges when they want to grow.

According to Global Safety Management, these unique challenges include:

  1. 8.Ignoring jurisdictional regulations.
  2. 9.Costly errors from operations.
  3. 10.Failing to evolve into an intelligent enterprise.
  4. 11.Delivering products, not business outcomes.

Ignored regulations often result in hefty fines. For example, if your pharmaceutical company sells its products in Europe, and then decides to expand into the U.S., not following FDA labeling regulations is a major no-no. Violating Section 21 of the Federal Food Drug and Cosmetic Act (aka, title 21, section 331) mislabeling a prescription drug for interstate commerce is expensive. Penalties include prison sentences up to 10 years, fines of up to $250,000 and civil penalties up to $10 million, the law firm of Wallin & Klarich states.

Problems often result from manufacturing errors and omissions. Many of these can be traced to the supply chain. For example, inaccurate inventory counts lead to starting a production run only to discover a key ingredient is missing, stopping production.

Evolving by using available technology as a way of moving forward can be done when company leaders are looking toward the future. Tools exist today—such as the Industrial Internet of Things (IIoT) coupled with modern enterprise resource planning (ERP) software—to let small and medium-sized businesses grow. They also let larger companies get even bigger.

Having total control over your inventory and an ever-changing grasp of your supply chain lets you reduce raw materials and shipping costs while still delivering products on time.

Translation Errors Can Prove Fatal

The final error in our “devils’ dozen” is:

  1. 12.Translation Mistakes.

Let’s face it: many American chemical manufacturers purchase materials from suppliers outside the U.S. and ship finished products overseas. That means labels must not only be in the languages used by your customers and others in the supply chain, they must also meet safety regulations at their destination.

If, for example, a formula using imperial measurements (i.e., pounds and ounces) is incorrectly translated into its metric equivalent or instructions are unclear, the resulting product may fail safety and purity tests. Poorly translated labels could cause regulators to deny a shipment until the products are relabeled correctly. Translation errors could even result in a large batch failing its tests, wasting the materials, time and equipment.

“If the mistakes are severe enough, the resulting chemical combinations could be dangerous or deadly for staff members who follow mistranslated instructions to the letter,” GLTaC states.

Under terms of the European Chemicals Agency’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) act of 2006, dossiers are required on each substance produced or imported weighing more than one metric ton.

“Inaccurate information due to translation mistakes could result in regulatory action by the European Chemicals Agency that could prove financially crippling,” GLTaC, a translation services provider, warns.

Technology Helps Reduce Mistakes

ERP software like Microsoft Dynamics 365, especially when paired with something like Xcelpros’ Integrated Chemical Management (iCM), helps companies better manage their growth.

Figure: 2Integrated Chemical Management with Microsoft Dynamics 365 Supply Chain Management

Integrated Chemical Management with Microsoft Dynamics 365 Supply Chain Management

ERPs can work with IIoT sensors, gathering large quantities of data. Dynamics 365 Finance helps turn the raw numbers into actionable data. Using this data, and the charts and graphs created from it, executives can spot areas operating inefficiently. For example, machines are down and staff is doing make-work while waiting for earlier cycles to complete.

Having access to real-time numbers lets these leaders know where changes can occur, boosting overall production.

iCM helps chemical companies hit their growth targets. It integrates seamlessly into D365’s Finance module, providing impeccable security. Among iCM’s value propositions are:

  • Built-in labeling and safety data sheets (SDS)
  • Fully integrated SDS management
  • Real-time SDS data sheets are consistent and compliant with Global Harmonization System requirements

These SDS features reduce the total cost of ownership (TCO) by removing the need to maintain product safety documentation and data in-house.

iCM becomes the repository of record for all regulatory data while making it accessible to authorized D365 users. It also integrates SDS authoring at the formula/item level, embedding workflows for authoring and approvals.

Xcelpros’ product adds to one of D365’s many strengths: its labeling prowess. The Supply Chain Management module lets companies track products from the moment raw materials arrive in their warehouse to the instant a customer receives them. iCM builds on the existing technology, further focusing on the chemical industry.

For example, iCM becomes the system of record for all labels, integrating them into operational workflows like production and shipping. To learn more, download the iCM brochure.

Figure: 3Translation Service Process in Dynamics 365

Translation Service Process in Dynamics 365

Customers using D365 also have access to the Dynamics 365 Translation Service (DTS). Hosted in Microsoft Dynamics Lifecycle Services (LCS), it uses a machine translation system to maximize translation output quality. It also recycles linguistic assets from D365 and partners, such as Xcelpros. DTS is compatible with D365 Finance, Commerce and CRM modules among others.

Summary

Chemical companies face potential mistakes common to all growing businesses. In addition, they also face certain hurdles that other industries do not. Regulation is a major issue for chemical companies, especially those who rely on raw materials and finished products made outside the U.S. or shipped overseas.

Taking advantage of technology like Microsoft Dynamics 365 and Xcelpros’ unique Integrated Chemical Management software can help prevent these mistakes and let executives continuously grow their companies.

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References: Distribution Of Mislabeled Products In Interstate Commerce

ERP in the Oil and Gas Industry
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ERP Solutions to Rev Up Oil and Gas Industry
ERP Solutions to Rev Up Oil and Gas Industry 700 500 Xcelpros Team

At a Glance

The Oil and Gas Industry is highly dynamic and volatile. Wars, politics and environmental concerns are some of the stressors affecting a capital-intensive industry. Centralized software that manages the nuances and intricacies will boost each company’s financial performance.

Enterprise Resource Planning (ERP) systems, which are becoming more common in many other industries, help to integrate all related tasks. One of the best examples is inventory and finance, letting companies know what they have and how much it’s costing them. ERPs help create a performance standard, letting companies set goals and use real-time data to know if they’re achieving them. Effective ERP solutions easily integrate tasks, manage risks, localize financial accounting and ensure quality checks.

Introduction

A slang term for crude oil is “black gold” because of its value. Oil is a pillar of the world economy, with prices playing a major role in determining the cost of goods and services around the globe. The industry’s size, complexity and high operating costs all demand organized management. Executives need to know where each asset sits in the pipeline. They need accurate, detailed data for planning and budgeting plus inventory and distribution.

Integrating ERP in the Oil and Gas Industry

More and more oil companies and refineries are starting to embrace ERP software solutions. Why? Because it addresses real-time business operations. Areas that benefit the most include:

  • Obtaining raw materials
  • Monitoring production
  • Managing inventory including spills, waste and burn-off
  • Tracking handling equipment

One major challenge facing oil companies is their broad distribution. For example, they can have production facilities in the Middle East and refineries in the United States, Europe and China. This means they have to maintain distribution routes almost everywhere.

Oil companies have an intricate supply chain that never stops working. This can add undue stress to both employees and equipment.

ERP software lets companies monitor operations from anywhere. They can know now, not in a week, the status of an oil field in Saudi Arabia or a tanker going through the Panama Canal. Modern ERPs help identify different ways to improve efficiency while boosting flexibility.

5 Key Reasons to Add an ERP

ERP solutions are the most viable option for improving production and overall management. Traditional companies in the Oil and Gas industry stand to gain significant advantages when they implement a modern ERP solution, including:

Figure: 1Key Reasons to Add an ERP

Key Reasons to Add an ERP

  1. 1.Ease of Integration: ERP solutions are designed to be stable, easily scalable and flexible. They function on-site and with cloud systems. ERP systems especially shine in asset planning and budgeting lifecycles. ERP solutions such as Microsoft Dynamics 365 easily integrate with a suite of related third-party programs. Instead of having a plant’s production department using one system and inventory management using something else, the entire operation is integrated into a single system. By having departments talk to each other, business meets its productivity standards, regulatory requirements and other deadlines.
  2. 2.Effective Risk Management: Risk management is a vital component of everyday business activities in the oil and gas sector. Geopolitical pressures, environmental concerns, social activities, asset damage, cost overruns for high-value construction projects, fines for non-compliance, cyber threats and protecting personnel: they all impact daily operations. Integrated ERP solutions let management identify potential risks. You can detect risks before they become expensive problems. Companies can balance and manage multiple operations simultaneously, ensuring they all run smoothly. By seeing how the supply chain functions in real-time, companies can prepare emergency contingency plans.
  3. 3.Efficient Project Management: A key advantage to ERP software such as Microsoft Dynamics 365 Supply Chain Management is its ability to manage complex supply chains regardless of their locations. An effective ERP helps manage both offshore and onshore operations, streamlining procedures driving basic business goals, helping to move raw materials to new markets. As individual shipments move from wells to refineries, ERP software lets companies adhere to regulations in every country and state along the way.
  4. 4.Localizing Financial Accounting: Oil and gas companies are aware of the huge capital investments, long lead times and unfavorable environments needed to extract and process their raw materials. Exploration and production frequently involve joint ventures to share the costs. Once the product is pulled from the ground, these companies face multiple regulations, compliances, currency risks, commodity pricing and other challenges as they move it from the wells to refineries and then to consumers. Efficient ERP solutions keep track of the regulations, taxes and fees in each region. They provide detailed financial records at every step.
  5. 4.Quality Control: Robust ERP solutions also integrate state-of-the-art engineering utilities matched with high-end total quality management (TQM) functionality. The result is a 360 degree view of quality issues, helping to address problems more quickly.

5 Features to Look for in an ERP Solution

Now that you’re aware of some possible uses, it’s equally important to make sure these five features are in whatever ERP solution you choose. The Oil and Gas sector’s sensitivities create unique requirements from its ERP solutions. These following features continue to be increasingly related to real-time operations and complex business compliance issues.

  1. 1.Asset Control: Managing all assets—such as locating new resources, acquiring them, and then refining the products—is vital for efficient operations. When you’re trying to find the best ERP System for an Oil and Gas Company, you’ll want to make sure it defines and tracks your assets, monitors their usage and availability, manages all documents, integrates mobile apps and data, and submits reports.
  2. 2.Agile QA Processing: Quality assurance is the key to constant improvement, especially in the oil and gas sector. Finding more efficient ways to convert raw materials into finished products helps offset research and development costs.
  3. 3.System Integration: Integrating existing software is often a key decision point in getting an ERP up and running quickly. It’s critical to make sure that whatever ERP solution you choose meshes with the software your employees use daily, otherwise you may face delays while work-arounds are developed. The perfect ERP solution creates superior analytics using real-time data from different sources. This will include workflows and service calls.
  4. 4.Standardizing Data Processes: The Oil and Gas industry is heavily impacted by precise management of workflows and global market analysis. Effective ERP solutions use a standard data storage method. Using this method, companies can balance multiple projects no matter where they occur: upstream (exploration and drilling), midstream (transportation, storage and processing) or downstream (refining crude oil and purifying natural gas).
  5. 4.Compliance: Many ERP solutions fail to deliver when it comes to overseeing complex compliance issues. Not being accurate often causes problems over time. Effectively managing different government regulations—such as when a pipeline crosses national or state borders—is a key benefit of a robust ERP solution.

Final Thoughts

The best ERP solution for companies in the Oil and Gas sector is one that:

Companies that navigate smoote implementations often start training almost from Day One. Training employees early gets their buy-in and lets people learn how D365 can make their work lives easier.

  • Integrates with a company’s current third-party software
  • Tracks inventory, plans capital projects and creates emergency plans
  • Streamlines the data into a unified flow
  • Collects data from diverse systems scattered around the globe
  • Allows the data to be used by any division
  • Integrates information from devices equipped with industrial internet of things (IIoT) sensors
  • Aligns with your company’s requirements to ensure minimal waste and deliver the best results

Expect nothing less than perfection. Having the right ERP solution will help you achieve just that.

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