From Customer Specifications to Compliant Products
Life sciences, pharmaceutical and chemical companies are challenged to not only be at the forefront of innovation, but to follow closely controlled processes to develop and manufacture products that meet the strictest quality standards. Production control, formula management, warehousing, and logistics have to be coordinated throughout the enterprise and they need to adhere to increasingly strict compliance regulations. Add to this growing competition and rising customer expectations, and organisations are compelled to reduce inventory management costs and optimise lead times.
itelligence helps organisations 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 life sciences, 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.
A Selection of our Life Sciences, Chemicals and Pharmaceutical Customers
Aspen Oss B.V.
itelligence knows the processes of pharmaceutical companies and, as an SAP specialist, can quickly implement the best practices to meet the stringent requirements of the industry.
Jeroen van den Broek, Manager Business Systems, Aspen Oss B.V.
In Focus: Compliance from MHRA and REACH to the FDA
The life sciences, chemical and pharmaceutical industry has some of the most stringent, yet least transparent, rules and regulations of any sector. Guidelines from REACH, the Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) ensure companies balance the requirements of internal quality with external regulatory compliance. This calls for integrated quality management, transparent formula management, and complete traceability of all goods and materials throughout their life-cycle.
Are you 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.
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Download the white paper nowBenefit 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 optimisation – 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 capitalising 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.
Packaging
Large-scale fraud cases have caused legislators around the world to take action. When it comes to product serialisation, 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 digitisation 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
Minimising 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.
Our Specialties in the Chemical and Pharmaceutical Industry
Gain Visibility and Process Efficiency with SAP S/4HANA
The SAP S/4HANA digital core provides organisations with an intelligent ERP platform and the opportunity to re-imagine core business processes;
- Drive sustainable growth and innovation: Designing, executing and capturing experiments in a closed loop process leveraging history lab data and knowledge base
- Gain visibility into business operations at any time: Enabling real-time financial close for faster, more accurate, and more collaborative decision making
- Introduce digitally-driven Manufacturing: Allowing for event driven adjustments of production plans/schedules, and establishing predictive models for asset maintenance and product quality
- Ensure agile and responsive Order Fulfilment: Capturing demand in real-time via sensors, run “ad-hoc” S&OP simulations or via automatically fulfil and deliver orders according to safe and sustainable practices
- Increase your margins through real-time Price and Order Management: Simulating prices and margins anytime, anywhere and at any level of granularity, and integrate real-time pricing quotes with available to promise commitments
- Take Workforce Safety and Efficiency to another Level: By fully digitising relevant documentation and by tracking and tracing workers exposure to hazards (via sensors), work and security authorisation and location
The Internet of Things – New Opportunities for the Process Industry
For continuing success, life sciences, chemical and pharmaceutical companies need to make product development and production more efficient. Machine-to-machine communication and the digitisation of processes allow businesses to better compete in the market. We help you to define your digital strategy and implement practical IoT scenarios.
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 specialised 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 serialisation of packaging, without the need for further customisation. It also enables you to integrate legally relevant processes such as those from REACH.
Towards a Connected Future with SAP GBT
Our customer Sanquin is heavily reliant on valid, transparent data to meet strict compliance regulations. Learn how itelligence supported the producer of lifesaving medicines by implementing the SAP Global Batch Traceability solution. Now, Sanquin can analyse its batch genealogies quickly and accurately to ensure what is most important to the company: patient safety.
More Useful Insights into the Chemicals and Pharmaceuticals Industry
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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