You are planning complex, ambitious projects and need capable support for the definition, planning, execution, control or close out? Then we can help you. Everybody can start a project, but finishing it correctly is more difficult. We provide you with our project expertise, if you have concrete questions or need assistance. Does your project gets out of control or you do you try to rescue what is left? We will get your project in shape again. Just ask us - we help you.
Expect more from your agile project management - we simplify projects and cut them into wise milestones. We take care especially to the requirements, because the more complex requirements are to be fulfilled for the interested parties, the more complicated and detailed the planning and execution are combined with higher costs. We will check with you the pros and cons and develop with you a strategic planning, which is balanced concerning the requirements. After planning we will perform as well the project management during the basic and detail design and execution. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
With Blockchain Technology the pharmaceutical and medical device industries are provided with a unique chance of improving overall compliance and regulators are getting the complete and immutable traceability of products and processes. The pharmaceutical and now as well the medical device industry are heavily regulated, because first of all it is a question of trust in the protection of patients. Where no trust is, one has to proof that everything is cGMP conform. With the new Blockchain technology the status quo can be changed to a point, where regulators can trust and rely upon always available lifecycle data from pharmaceutical and medical device products, production, distribution and logistics. All generated data is accurate, verifiable, secured through encryption, automatically written into the blockchain layer, so all information is always recorded. Blockchain is providing all these abilities regarding compliance and business aspects. This can be illustrated in use case examples:
Due to the U.S. Drug Supply Chain Security Act (DSCSA) supply chain security has recently gained attention in order to battle the counterfeit drug problem. Counterfeit drugs are drugs that do not contain the active ingredients they are supposed to and consequently can harm patients. The supply chain in the
pharmaceutical industry is complex, with drugs changing ownership from manufacturers to distributors, repackagers, and wholesalers before reaching the customer. Using the immutable Blockchain technology can increase trust and transparency, with customers, doctors or patients being able to track pharmaceutical products throughout the complete supply chain.
The pharmaceutical production process of a film coated tablet can be verified using blockchain token for proving each operational step with the necessary process parameters, including calibration verification and engineering or qualification / validation of documents, if needed. With Blockchain technology it is possible to collect all process data live within production for all different steps in order to prove the cGMP compliance of the overall production, storage, packaging and distribution at each point in time.
Today, most documentation is still paper-based or based on electronic files. But there is not yet an electronic link between the cGMP requirement and its proof. By linking requirement documents, process execution documentation and personal signatures with digital fingerprints on a Blockchain, everything is tied together under one single point of entry. Blockchain technology provides on common data access interface for inserting and extracting data, applicable in all corporate areas and divisions, regulating authorities and auditors, making all data access easier and all processes holistically traceable. Auditors can directly see a complete chain between requirements and their implementation in the production process to be correctly verified. This will build a deeper trust into the overall qualification and validation activities.
The very same strict and secure documentation mechanisms can be used for drug development activities, from technical trial, clinical studies as well as pharmacovigilance, providing a deep transparency inside the drug development system.
ARXUM Business GmbH, located in Zug, crypto valley Switzerland, provides the blockchain based system solution to set the scattered businesses in the pharmaceutical industry on a blockchain basis, down to the granular level of linking production machines
to smart contracts on the Blockchain.
ARXUM uses Blockchain technology to integrate data from diversified sources in the pharmaceutical & medical device industry. A prescription or a manufacturing order is created as Ricardian smart contract on the Blockchain. All manufacturing peers, such as clients, manufacturers, suppliers, transport agents and providers of digital services, gain fine-controlled access to relevant production data.
Blockchain technology provides for immutable traceability on several levels:
The global ARXUM Production Protocol is one single standard to connect all manufacturing players to a protected Blockchain infrastructure, providing end to end
visibility on all relevant production events. Practitioners, manufacturers, material providers, transport agents, payers and insurances, as well as internal stakeholders such as engineering, maintenance and operations have discriminated access to the same data on the blockchain. All data is securely stored with digital fingerprints and protected against manipulation. This provides secure product identification, immutable traceability and a complete audit trail for internal or external regulators.
ARXUM provides the ARXUM Connection Box (ACB), a cyber-secure IoT gateway for production machines which directly communicates with the Blockchain, thereby eliminating potential manual manipulation. Further, existing IT infrastructure is connected to the ARXUM Production Protocol through a programming interface (API) towards ERP systems or
manufacturing execution systems. Based on the ARXUM Production Protocol, the ARXUM Production Network provides
several, distributed applications to the different stakeholders to access the production and product data. Data is stored in different distributed ledgers, such as for prescriptions, production events and processing data, transport & end deliveries, product data or regulatory requirements.
The distributed ledgers are accessible for various purposes, such as post processing analysis, predictive engineering & maintenance. Various digital services can be integrated:
LEANspiration Consulting GmbH, located in Stein, Switzerland, provides the regulatory background and experience in CSV to bring true value through regulatory preparation, systems validation and system performance qualification. In the pharmaceutical and medical device industry every tool needs to be controlled and verified. Due to years of experience in the introduction of new technologies LEANspiration cares for the regulatory fit of the ARXUM solution. This generates true value through regulatory preparation, systems validation and system performance qualification, including supplier qualification documentation for the hard- and software of ARXUM.
LEANspiration & ARXUM together provide the future oriented, secure and effective solution for the pharmaceutical and medical device industry. A new standard based on Blockchain technology, enabling a fully digitalized connection between end practitioners, patients, manufacturers and their suppliers down to machine level.
Contact LEANspiration: +41 (0) 79 393 30 05, firstname.lastname@example.org
Do you want to acquire and built-up new markets, new customers, new segments or introduce new products and services? We provide services and products in the area of Business Development for organizations, which leads to new markets, new customers, new market segments and the introduction of new products and services. Improving your sales and revenue is our priority number one.
You need help from outside? We come gladly to you and coach you. We help you with your problematic and search with you for viable solutions, which will help you practically. In case you need us longer as predicted, this won't be a problem - we always find satisfying solutions. We are glad to help you with analysis, reports, presentations and case scenarios analysis. We propose as well coaching sessions, where you will already work practically on your issue. During the coaching, we will guide you directly to the problems and solutions, which are needed. We support you for complex issues and teach you the required know-how and how you can analyze and present it. Throughout the process or complex issue, you have to master, we support and guide you. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
Data Integrity is the accuracy and consistency of data over the whole life cycle. It is a very important topic, which needs to be addressed and covered well in order not to loose data, nor unauthorized access is granted and more. We can provide you with our standard solutions regarding Data Integrity.
Main problems to be addressed for all data inside an organization are:
US FDA definition of ALCOA:
We help you to overcome all the problems regarding data integrity. We analyze your status quo and map your road to take for data integrity. Start today - our digital world does not wait. Just get in touch with us - we welcome your proactive approach.
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance to ensure that a food or drug product is safe for human consumption.
All GMP guidelines follow a few basic principles:
You are driven to achieve a higher productivity and being leaner than before. This is possible through the reduction of waste and unnecessary repetitions or delay times. When we are screening with you your process then we focus on the target and the actual situation and everything which is not intended will be reviewed. We are using lean tools, in case the problems are not obvious. There is no need using oversized measures, when common sense is sufficient. Most problems can be solved easily skipping the complicated stuff.
In case there is an accumulation or anomaly respectively a lack of discipline, we will search for the cause and solve the root cause. Oftentimes the customer view is ignored, but in the end the customer is only paying for value. The customer focus is important and shows to the business management, what is not part of the product or the service. In case it is passively related to produce value, it has to be resized to the correct size. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
If you are searching competent consulting for your process reorganization or optimization? Then you are at the right place. We help you to renew your process landscape and adapt it to future challenges. Due to our experience in business process re-engineering, we can analyze your processes fast and efficient and optimizing them. We validate your processes and check the performance. According to the task, we analyze, evaluate optimizations and implement these with you. Ask us - we help you.
We deliver outstanding Qualification / Validation services and products for the pharmaceutical and medical device industry according to cGMP standards. Quality Coordination and Agile Project Management of your life science projects are our core competency. What value does your project has without the necessary quality behind it? We strongly focus on quality solutions in the pharmaceutical and medical device industry. Our clients expect the best and we deliver it. Performance Qualifications of up to 300 pages speaks of the focus to detail we care for our clients and their processes. We prepare and bring your critical product Launches to success. Our focus is that you can operate your facilities and equipments to the best degree possible form a GxP standpoint to a productivity and LEAN view. We deliver Qualification and Validation services for Solids, Steriles, Biologics and Bio-similars. We focus on first time right, because you will always be faster and more economically with this approach, especially in the life science sector.
Our services in the field of Qualification / Validation:
You are searching competent consultancy for the development, reorganization or optimization of your quality management system (QMS)? Then you are right here. We help to renew and adapt your QMS to the future. You want a proactive QMS and need help or want an audit as check of your actual QMS performance. Ask us - we help you.
The new issue of the ISO9001:2015 has to be implemented, which focusses explicit on the improvement and usage of knowledge and risk management in your company. Knowledge sources and storage should be marked in the inputs and outputs of your processes. Everybody sees directly the responsible person for each process step and which inputs he needs and which outputs he generates. The whole process gets more transparent, who is doing what and when. All interested parties should be documented with their requirements towards the company including how the company will handle these requirements. The new issue has showed the sincerity how quality management is implemented and certified in companies is not enough, though ending the quality show and demanding real effort regarding quality. A lot of companies are understanding under quality some kind of alibi system for the deception of their customers only in mind "get me that certificate", this you should never do. Trust yourself and do it right first time. Offer first more quality and then lower costs - not the other way round and then wondering why there is no quality anymore. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
Implement a Quality Management System (QMS)
If you want to implement a Quality Management System (QMS) in your organization and need a thorough basis of good business practice, we propose you our standard swim lane processes of good business practice for your organization. We deliver you our Quality Management System standard for the fast implementation of a working Quality Management System in your organization. You can adapt the processes to your specific needs and internal requirements on your own. We support you a well in the establishment of your standard operating procedures, guidelines and forms. In case you would need help from our consults for these tasks, please contact us for these purposes.
Our offer for your Quality Management System (QMS):
Just ask us for further information, we are pleased to help you.
Focus your quality management on the most important aspects in the easiest form and simplify the life of your staff, instead to make it more complicate. Orient yourself after your staff and improve continuously the processes, making everything easier and smoother. Only through relentless optimization you can reach a high degree of quality and customer satisfaction at lower costs. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
The Supply Chain Management (SCM for short) is a management approach in which all flows of products, raw materials and components are recorded in a process-oriented manner.
The goal of the SCM is the optimization of resources. This objective requires the consistent mapping of all material and production flows, from order or production to delivery.
As a rule, this creates cross-company transparency. Economic decisions are supported, information data is available in real time.
A good supply chain management represents the key function in the enterprise. For this purpose it must necessarily be integrated by an outstanding network integration. If this is the case all areas can be related to each other and the overall view of all areas is guaranteed.
These include transport, warehouse and production management, as well as order management. Procurement, distribution and production planning are based on these areas. This in turn is based on network and demand planning.
A good SCM increases customer satisfaction, quickly adapts to changing markets, lowers inventory, simplifies goods flow and reduces delivery times.
Using the example of the fashion industry, where there is fierce competition and customer requirements change very quickly, the meaningfulness of a supply chain management can be presented very well. Narrow profit margins of retailers are putting a constant pressure on manufacturers. If you want to offer an excellent service here, you must have an excellent SCM.
In the worldwide supply chain of the fashion industry, above all speed, transparency and flexibility are required. With a good SCM, this is not a problem. Since all processes and departments can be analyzed in real time and displayed in a complete overview, the needs of the customers can be identified in good time and successfully operated. The manufacturer is maximally flexible and can offer the customer a highly transparent processing with fast delivery time.
In addition, the market is monitored using the supply chain management system. It is possible to react immediately to changes in requirements due to new or simply changed customer requirements and delivery routes. In the best case scenario, the manufacturer recognizes customer needs before the customer himself, thus offering innovations that ensure customer satisfaction and loyalty.
The fashion industry is very fast paced. Not only that there are four collections per year, the fashion trends sometimes change outside of the collections very quickly. A good SCM analyzes the current market situation and compares with historical data. On this basis, a prediction of the market trend is possible. Production and warehouse management can be prepared for future requirements at an early stage.
Artificial Intelligence is a mega trend with an increasing importance for companies. Our world becomes much more intelligent through intelligent programs, but only as predefined by humans. The question of our future will be what is intelligent, but rather what enables us making our daily life easier, faster and more competent as status quo. Intelligent daily life algorithms are just the beginning, because the recognition of relevant data and it's clustering is the prerequisite for a successful artificial intelligence. More and more easy and semi-intelligent, automated tasks will be fully automated with artificial intelligence. Start now - we support you.
See your vision transforming into reality. We realize what others cannot see, through organizational changes with a structured, systematic approach. We concentrate us, how change management can be seen as a chance and implement it accordingly. We guarantee you success, if you see structural corrections as inevitable and we will support you. The reduction on the vision, the values and the concrete facts, on which the transformation is based, are pillars next to an adjusted communication. Let changes and enhancements arise, who have to deal with them daily. We transform your approach and ask us, what can we do that these developments come form internally and not top down.
In case you are still inside the industrialization or post industrialization age and are not yet arrived in the digital world, we help you to transform your business model in the digital age parallel to your actual business. Be thrilled to reach new digital customer groups and make a mark that you shape your business towards future digital generations. We show your company, what advantages it can collect due to artificial intelligence and big data. Differ your company due to the fact that you have a digital strategy. Digitalize your whole company and we don't speak of island solutions, but rather develop early on your own digital business model. Connect your company and supply chain with the blockchain technology.
A working and tested emergency management system is a crucial business foundation for a running company. Your staff cannot work productively, if indispensable systems or processes malfunction or even fail. For preventing this or reducing the probability, you have to check your systems and processes for these risks, optimize them and generate emergency plans, which will start automatically. This will increase your reliability. If you manage your organization always at the limit, you must detect system faults and correct them. Most companies are not prepared for all eventuality and therefore force is missing in case a major breakdown is caused. Start today and make your company more resilient. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
A lot of new ideas won't come through or are implemented non satisfactory, because they are not competent coached and incubated. You have to build new business models at minimal level, test and mature them with a few customers, before you can grow them with a lot of customers. Later the focus lies on sales, whereas additional functionality wished from customers have to be implemented in parallel. Here, the team and its share in that start-up are the main factors. You have to keep costs really, really low, because new business models generate nearly no gain due to the small market penetration during the incubation phase. There is a difference between copy-cats and disruptive, innovative business models. To develop and built up a disruptive and innovative business model is more interesting, because you have the advantage of being first and having no or significant less competitors. In case you need help, just ask us - there is always a way. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
See the future before you, how your products and services define a new, higher level. We lift you in the innovative world with new possibilities. Enjoy being a part of shaping the future. Nothing is more exiting than creating the new status quo and to see how competition is copying your success recipe and that you are becoming better from this exchange. No, true innovation is nothing for weak and passive people, but always worth the pain. A lot of company internal ideas are stuck, because the potential is not used or the team behind cannot be put together. Behind each innovation there are people, who are burning for innovation and creating what anybody has reached before. Now is the moment to let off old ideas and business models and to focus on new, future gain drivers with your own talents. We lead the world of innovation and demand being an innovation driver. Only through real breakthroughs our world reaches higher levels. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
You need asap an interims CEO or similar, due to a problem - we propose you competently what you are seeking. We assume the work of your last CEO and optimize your existing business model, increase liquidity and perform cost optimizations. In case needed, we reorganize the company. Your are seeking intelligent solutions, then you are right here. We develop your company further, so that it can be taken over safely after a crisis or a leadership change. We optimize your human-resource allocation and implement cost accounting and budget planning in your company - always looking to enhance the business model. Starting new technologies for future gains with minimal resources is an art, where we do our best. We introduce an efficient claims management and control it regularly. We use modern key performance indicators, which are reflecting the reality, which can be used for efficient decision making. In case a modern decision management system does not yet exist, we will implement it, so that you can make your decisions based on numbers, data and facts - we let the gut feeling for you. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
A efficient and effective knowledge management, which is integrating itself seamlessly in the company culture, is still a wish in many companies. Subject Matter Experts inside the company play a crucial role. A lot of tasks are easily done, because the SME has enough knowledge and instructs best case others. We build structured processes for a successful company knowledge management and check the effectiveness. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
If you are searching a new generation of leadership concept, due to the always faster pace of company change, then we will check for the required changes in your company, plan and execute them with you. For the new, digital oriented talents, we are developing a new corporate culture. Leadership is not a word, but rather your future: Develop your own leaders with a new training concept and improve your gains and the satisfaction of your talents. The actual fluctuation will be significantly less.
Human resources development is a permanent process, which we examine with you, in order to find growth potential and realize it. This will lead to a staff who has the necessary competence and knowledge for a more productive work.
Always higher expectations on data protection, quality, safety, environmental and risk management system requirements, as well as agency regulatory makes our world a safer place, but not necessarily the company management easier and more efficient as it should be. It is in the hands of the business management to optimize and implement high efficiency. We show you, which rules are valid for you and how you can best optimize your resources in order to concentrate on the most important.
We enable you with a new look from outside on your brand and product management, as well as your price and sales policy for future trends. We define new brand and product renewal and nostalgic products for you. If you think your customer management and press could be more modern, efficient and more striking, than we help you finding the necessary improvements, to implement them and save the benefits for you. We rejuvenate and optimize your marketing - watch out for new trends and customer groups. Tie your customers from tomorrow already today with your company, brand or product. Ask what your customers really expect from you in the time of the digital change and examine your customer groups better. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
Rejoice yourself on our accompanying expertise for your restructurings and reorganizations in your company. We lead for you necessary cost cuts and process optimizations through and present you the facts prior and later. With our expertise we develop your organization organically or growth driven further and being state-of-the-art.
In case you prepare your company on your succession, but would rather want that the company is ready in terms of its numbers, data and facts, we support you.
We identify the necessary organizational performance improvements in the course of an IPO. We optimize long-term your KPI's and built up a new basis of trust, in order that your company will be regarded as solid with growth potential by your stakeholders.
In case you are not satisfied with your operational KPI's, we will conduct a detailed KPI analysis and show your potentials and realize them with you. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
We analyze your existing production planning and find bottle necks, weak points, supply problems and communication errors. Based on this analysis, we develop deep going optimizations, restructurings, workplace analysis, lean management and develop a newly and optimized production planning. The resulting productivity growth are your personal competitive advantage.
If you need urgent standardization - we will execute these and show you the resulting advantages.
A lot of companies loose a lot of money and time in the research and development, because of the underlying creative process behind, but mostly on the consequences of the non-standardization and non-systematization. We help you with a systematic and standardization approach for the efficiency increase and optimization of your creative process and develop, test and implement it. Through these measures we can reduce your time till commercialization of your products or services significantly and increasing the return. Often is the overall research and development process not appropriately organized, we aim to short the steps in-between the research and development phases as well.
Mostly your developments needs more time, because the time is wasted (non-value-added) or underused (not using the full potential).
A risk management system acc. ISO 31000 is required or you need an efficient risk management in your company - then we can help you. Risk management can be very efficient, in case you concentrate on the most critical points and start only with the less critical, after successful solution of the first ones. We help you defining the necessary corrective measures, in case you need support. We are your management consulting and provide you with the specialists to this topic. Ask us: LEANspiration Consulting - your management consulting.
Envision with us your future. Where do the market will develop itself, which trends are growing, why has your competitor more success? Deal with all these interesting topics and define your business model for the future. Define new business areas or transform your existing business model - we will accompany you from the start till the end. Trust your talents inside your company - we will listen to them and evaluate the optimum for your company. Define your strategic growth and future targets using profound analysis. When you buy a company or sell a business area, you will find with us the necessary expertise and companionship.
Increase the workplace satisfaction and digitalize it. Learn new approaches and change yourself the workplace. New generations see modern technology as a must and not facultative. Face the challenges! Set the focus on integration and transform your organization, so that it is growing together to a global operative unit. Trough a more optimal connection you will be able to drive a global business model as other successful companies already do. Many regional business models doesn't lead to the wished efficient level and the demand on a global company.
Push the technology development in your company and implement systems of strategic relevance for the market leadership of your business model. We will develop technology platforms of tomorrow with you, which will generate a big part of your future gains and will be a solid fundament.
Become agile and be ahead of competition, because you foresee the actual market development, trends and new cycles and adapt your business model accordingly to the new reality. Put yourself to the future winners and not to the losers.
Growth through fusions are complex in the integration of the bought company and need a careful planning, execution and close-out. Mostly buying companies are totally overloaded with such once in the time transformations. We know how you can reach it easier, though different products, requirements, languages, IT systems and regulatory requirements etc. Go with your company during fusions on the fast lane and not on the emergency lane. In case you have problems with actual fusions, we are ready to support you.
KPI's are only facts, if you did the correct strategic planning and execution, then you have valid data.
Possessing a technology leadership gives you a quasi monopoly. This is why it is very interesting and lucrative. We show you how you can reach it. Technology transfers are the little brother of the technology leadership and help you to define trends and being first player.