Life Sciences & Chemicals

Ensure End-to-End Compliance in Life Sicences & Chemicals

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 pharmaceutical and chemical 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 Pharmaceutical and Chemical Industry

For continuing success in the future, pharmaceutical and chemical 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.

Solution for the Pharmaceutical industry

it.lifesciences for pharmaceuticals – Our expertise for the pharmaceutical industry

Optimize your process results and comply with international laws and regulations. it.lifesciences is based on standard SAP software and handles all standard financial, commercial and logistic processes without a hitch. The SAP functionality is supplemented with industry-specific processes designed for purchasing, planning and production, as well as sales, management and quality control of the total chain.

Find out more about this solution.

Is Your Pharmaceutical or Chemical 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 supply 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

Serialization

Serialization within the pharmaceutical industry, the international regulations and complex logistics drive the need for excellent IT solutions and knowledge. ATTP (Advanced Track & Trace for Pharmaceuticals) fulfills your Serialization requirements . This innovative serialization and unit-tracking tool enables medicine-producing companies to validate their products, integrate their business processes and collaborate with regulators and business partners. The SAP Advanced Track and Trace for Pharmaceuticals application supports effective compliance with global pharmaceutical serialization requirements. With this solution, life sciences companies can help ensure patient safety.

Read more in our Serialization Factsheet

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.

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.

Our Specialties in the Chemical and Pharmaceutical Industry

Blood Plasma Industry

Since 1997 we support the Blood Plasma industry with our services. Our experiences over the years, led to the development of a Plasma Best Practice based on SAP. The consultants of our dedicated plasma team are familiar with the complex business processes and know how to work in strict GMP/ Validated environments. We are proud to say: ‘we speak the language of the customer’. This applies to all of our experienced consultants.

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.

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.

Strictly regulated, yet flexible

The dynamics within the pharmaceutical industry are at odds with strict regulations. Our industry-specific solutions enable customers to demonstrably comply with legislation, but also provide the necessary flexibility to respond quickly to continuously changing market conditions.

Frans Nieuweboer, Director Life Sciences & Chemicals, itelligence Benelux

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.

Validation is one of the fundamentals for patient protection. itelligence helps you with our experience in Computer System Validation. Risk Based Compliance focuses on identifying the actual risks for the patient, the product and the data integrity. Savings on validation costs can increase enormously by focusing on the real risks. In many cases, it makes the processes more transparent and therefore more effective.

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.

How Our Customers Benefit from Us

DuPont, Copenhagen, Denmark

The BPC training project at DuPont in Copenhagen was executed as a 30 day BPC trial, where the EPM team members at the former Danish-owned company Danisco received training in the BPC software.

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Amminex, Søborg, Denmark

Usually, companies need to adapt existing processes to the ERP system, but the Danish start-up company Amminex lets SAP set the standard from the get-go.

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Cheminova, Harboøre, Denmark

Cheminova’s bottling lines operate around the clock and the group is active in many parts of the world. Thus, the stability of the ERP system’s operations 24 hours a day is crucial for the company.

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SVZ International B.V., Breda, Netherlands

SVZ, frontrunner in the food industry for more than 150 years, strives to offer highest quality in production and supply of purees, juices, and concentrates made from freshly picked fruits and vegetables.

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Synthon B.V., Nijmegen, Netherlands

The innovative industry leader Synthon, located in Nijmegen, produces high-quality generic medicines, biosimilars, as well as new biological and chemical entities.

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Sanquin, Amsterdam, Netherlands

Sanquin is responsible for safe and efficient blood supply in the Netherlands on a not-for-profit basis. Sanquin also develops and produces pharmaceutical products, conducts high-quality scientific research, and develops and performs a multitude of diagnostic services.

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Amminex, Søborg, Denmark

SAP ERP combined with a BusinessObjects platform is part of the Amminex preparation for global expansion. The environment consists of SAP BusinessObjects Planning & Consolidation, and itelligence has implemented thesolution, which the Amminex Management uses today to follow up on economy and time.

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Cipla Europe NV, Antwerp, Belgium

Headquartered in Antwerp, Belgium, Cipla Europe is a leading global provider of medicinal products, such as respiratory, HIV, vaccines, over-the-counter medicines, active pharmaceutical ingredients, plain generics, and hospital products.

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Aspen Oss B.V., Oss, Netherlands

Based in the Netherlands, Aspen Oss B.V. provides the world with vital pharmaceutical products, such as steroid hormones, Heparin Sodium, peptid and alkaloid products.

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Dr. August Wolff GmbH & Co. KG Arzneimittel

Dr. August Wolff, headquartered in Bielefeld, has been researching, developing, and marketing pharmaceutical products for over 100 years. The company has specialized on dermatological and gynecological products, medical products as well as cosmetics.

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Customer video Bilthoven Biologicals (BBIO) & itelligence

Bilthoven Biologicals (BBIO) was looking for a state of the art solution to simply their application landscape by reducing the number of applications and improving the support for existing business processes. BBIO now has a fully transparent logistics chain thanks to the implementation of SAP S/4HANA.

Watch our video

Towards a Connected Future with SAP GBT

With SAP Global Batch Traceability, Sanquin now has the ability to integrate all the batch relevant data, using internal and external sources and get a direct overview of the supply chain from a logistical and quality perspective. This continuous ‘situational awareness’ will in the end protect their product, their brand and more importantly their patients.

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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.

Download the whitepaper

More Useful Insights into the Pharmaceuticals and Chemical Industry

The right formula for your pharmaceutical challenges

itelligence adds value for pharmaceutical companies and producers of medical devices with its unique combination of knowledge of the sector, legislation and IT.

Watch our video

Well Prepared for the Growing Digital Economy?

Our expert, Brain Everett, recommends: “Seize the opportunities; significant value will be created in the form of improved supply chains, greater agility, and enhanced customer experience.”

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The Innovation Challenge of Digital Transformation and what it Means for the Chemical Industry

Make the most of digital transformation as a key driver for global success and true business value. Be a disrupter, not the disrupted.

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Are You Still Struggling with Strict Compliance Rules in the “World of Beauty”?

Our solution it.lifescience for cosmetics covers all production compliance requirements. Close process gaps and keep up with regulations.

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Eager to Find the Right Formula for Pharmaceutical Challenges?

it.lifescience combines security with enhanced functionality for all pharma processes. Comply with regulations in a cost-effective way.

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Speak to Us Today

Are you searching for answers or would like to receive more information on the chemical and pharmaceutical industry? Do you want more detailed advice from our expert or wish to book one of our chemical and pharmaceutical sector workshops?

Just contact us – we will be glad to help you.

Your contact: Frans Nieuweboer Director Life Sciences & Chemicals +31 40-296 86 00

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