Chemical and Pharmaceutical Industry

Ensure End-to-End Compliance in the Process Industry

How integrated IT solutions for pharmaceutical and chemical companies improve productivity and security.

From Customer Specifications to Compliant Products

Pharmaceutical and chemical companies have a lot to take care of. Production control, formula management, warehousing, and logistics have to be coordinated throughout the enterprise. At the same time, these companies need to adhere to increasingly strict compliance regulations. Growing competition and rising customer expectations are compelling SMEs in particular to reduce inventory management costs and optimize lead times.

itelligence helps your organization prepare for the challenges of the digital future – regardless of which area of the process industry you operate in. Our industry-specific, integrated IT solutions for pharmaceutical and chemical companies support each and every step in your value chain. In this way, you can ensure that your processes are transparent, compliant, and cost effective.

Aspen Oss B.V.

itelligence knows the processes of pharmaceutical companies and, as an SAP specialist, can quickly implement the best practices in our sector, so that we meet requirements of regulators like the FDA.

Jeroen van den Broek, Manager Business Systems, Aspen Oss B.V.

In Focus: Compliance - from REACH to FDA to GMP

The chemical and pharmaceutical industry has some of the most stringent, yet least transparent, rules and regulations of any sector. Guidelines include those set out by REACH, the Food and Drug Administration (FDA), and Good Manufacturing Practices (GMP). Companies must pay as much attention to environmental and safety regulations as to documentation requirements.

This calls for integrated quality management, transparent formula management, and complete traceability of all goods and materials throughout their lifecycle. Achieving all this without costs skyrocketing is only possible with the right knowledge and integrated IT infrastructure.

The Internet of Things – New Opportunities for the Process Industry

For continuing success in the future, chemical and pharmaceutical companies need to make product development and production more efficient. Machine-to-machine communication and the digitization of processes allow businesses to better compete in the market. We help you to define your digital strategy and implement practical IoT scenarios.

3 Ways Innovative Chemical Companies Are Transforming Their Business

Not only is the chemicals industry confronted with an increasingly competitive market – volatile energy prices, regulatory requirements, lengthy product innovation cycles, and complex global supply chains make business even harder. Get to know Brian Everett’s innovative solution approach.

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Is Your Chemical or Pharmaceutical Company Facing the Following Challenges?

  • Are you finding it more and more difficult to adhere to increasingly strict compliance regulations such as documentation requirements?
  • Is your delivery chain complex and hard to monitor, to the extent that it causes problems in formula management and batch management?
  • Are unconnected, time-consuming production control processes holding you back?
  • Do you lack the transparency necessary to ensure comprehensive quality management and assess it in detail?

If so, you may need to rethink your processes. And that’s where we can help you.

Benefit from an Integrated Value Chain

Production Control

Many chemical, pharmaceutical, and cosmetics companies began automating their production processes long before “smart factory” was an established term. However, end-to-end integration into the SAP system in particular provides considerable potential for further optimization – especially from a financial perspective. Integrated batch management and quality checks are central to this.

In addition, many production steps require a digital signature. In some instances this is obligatory, while in others the guidelines give some leeway – and capitalizing on this can lead to financial savings. This calls for expertise that itelligence specialists have gained through their involvement in countless projects over many years and that they always keep up to date.

Packaging

Large-scale fraud cases have caused legislators around the world to take action. When it comes to product serialization, it is no longer enough to consider only the outer packaging – especially of pharmaceutical products.

Inner packaging also needs unique identifiers, such as serial numbers. For packaging types like blister packs, this can drive up costs. This is because applying a number to this kind of packaging can require laser technology, which is far more expensive than standard labeling.

But what are the mandatory processes? And where is it necessary to compromise? Those who can answer these questions can potentially save a lot of money.

Research and Development

For future-oriented companies, developing new products with the right properties and best possible cost structure has always been a key focus. Thanks to digitization in the form of collaboration between business partners during the development process, enterprises can achieve this with less risk and greater cost efficiency than ever before.

The prerequisite for this, however, is that research and development are closely integrated into the existing IT landscape and that processes run smoothly.

Production Safety

Minimizing risk to humans, products, and the environment is an every-day duty for chemical companies. In supporting this task, the processes and technologies enabled by the Internet of Things (IoT) can play a decisive role – by simplifying hazardous materials management, for example.

Furthermore, pressure sensors incorporated into chemical pipelines can detect when even minute quantities of hazardous substances are leaking. In this event, they turn off the devices and report the incident to the integrated IT system.

Track and Trace

Today, pharmaceutical companies have to prove that every drug produced reaches the end customer – the pharmacy – in its original condition. This means they have to ensure traceability in batch management, from production to delivery, and guarantee that all products remain within the correct temperature range.

And this is where the Internet of Things comes into play. In conjunction with temperature sensors and labeling, the IoT enables you to track a product throughout its lifecycle and test it in real time.

IT Validation

Companies in the pharmaceutical industry have to validate their IT systems in accordance with guidelines set out by the EU and the FDA. However, the majority of decision makers are unsure exactly which systems this applies to – and to what extent. This uncertainty results in unnecessary costs.

itelligence has used its considerable knowledge of the industry to develop a cost- and risk-optimized project approach that can lead to financial savings of up to 40 percent.

Our Industry Specialty

Cosmetics Industry

Like the chemical and pharmaceutical industry, legal regulations in the cosmetics industry are incredibly stringent – but they are also unique to the sector.

With many years’ experience in the industry and an IT solution tailored to its specific requirements, itelligence helps you overcome the increasing challenges of the digital age – from in-process product testing and sample management to maintaining a full audit trail.

Blood Plasma Industry

Our vast experience in the blood plasma industry led to the development of a Plasma Best Practices based on SAP ERP. In this Best Practices we combine proven SAP ERP technology with our industry specific solutions.

The consultants of our dedicated plasma team are familiar with the complex business processes and know how to work in strict GMP/ Validated environments.

Medical Technology

Medical technology companies need to focus more than ever on delivering faster and cheaper products that enhance patient health care. With our experience in GMP, FDA regulations, audit trail management and serial number packaging processes, we can help you focus on your core business and your customers, and spend less time and money on compliance.

From Risk Analysis to Training

Companies have to balance adhering to external regulations with the success of internal processes. They need to abide by the principle of “as much compliance as necessary; as little effort as possible.” For this, you need an IT partner who understands the industry and thinks consistently as well as economically: just like itelligence.

Stephan Limberg, Head of Industry Management for the Process Industry, itelligence AG

30–40% of the Costs Associated with IT Validation Are Avoidable

Implementing industry-specific regulations, laws, and guidelines on an IT level can quickly become expensive, as doing so means adapting standard processes.

With solutions specialized for the industry and a tried-and-tested project approach, we can help you reduce this expenditure. This allows you to support logistical processes, including serialization of packaging, without the need for further customization. It also enables you to integrate legally relevant processes such as those from REACH.

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Always in the need of meeting strict compliance regulations, our customer Sanquin is heavily reliant on valid, transparent data.

Learn how itelligence supported the producer of lifesaving medicines by implementing the SAP Global Batch Traceability solution. Now, Sanquin can analyze its batch genealogies quickly and accurately to ensure what is most important to the company: patient safety.

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By Goldfish, an itelligence Company

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