Pharma & MedTech
Product and production safety thanks to compliance and ICT deployment
The tension between innovation capability and regulatory requirements presents the pharmaceutical and medtech industry with major challenges in terms of technologies and processes. Conventional IT tools and organizational forms are no longer sufficient to meet all requirements. Rather, this requires both industry-specific information technologies and innovative and integrated solutions that guarantee a high degree of security. Digital business models and focused innovation management pave the way for pharmaceutical and medical companies to engage more intensively and directly with patients and open up new, forward-looking business areas and platforms.
The new European Medical Device Regulation (MDR) is a topic that is currently occupying every medtech company. In order to meet the complex requirements of MDR, affected companies will have to be able to track the life cycle of their products along the entire supply chain. In addition to MDR-compliant processes for risk management, this also requires uncompromising quality assurance, which can only be achieved through optimized supplier management and close cooperation with distributors.
How we can assist you:
Our consultants have been working for many years in various mandates for pharmaceutical and medical companies. In addition to innovative technical solutions, they take care of efficient process design and agile handling of often complex projects. The approaches we pursue optimize flexibility, traceability, sustainability, quality and safety equally. In addition, our experts will support you in your operations, for example in the preparation or follow-up of audits and their results. As an independent and product-neutral partner, AWK's customers include renowned pharmaceutical and medical companies such as Novartis, Synthes, Vifor and Bayer. The range of services we offer combines expertise from the fields of project management, ICT consulting, cyber security, data analytics, digitization, compliance, merger & acquisition and divestiture.
Your contact person
Unique Device Identification (UDI) - Holistic View in the Context of Master Data Management
E-Paper (2021/05)
This paper illustrates a possible approach
to ensure that an overview and the required efficiency are maintained, from analysis, solution finding and implementation
to monitored operation.
Customer reference - Leading pharmaceutical company in Switzerland
Customer reference (2020/10)
Action plan for CIOs, CTOs and CDOs of Swiss industrial companies
E-Paper (2020/03)
CIOs, CTOs and CDOs are faced with major technical challenges. In our publication "Action Plan" we describe first steps how CIOs, CTOs and CDOs can tackle this challenge.
Resilience
AWK Focus (2019/10)
The buzzword "resilience" is omnipresent in the entrepreneurial context for one simple reason: the future is becoming increasingly difficult to predict in concrete terms. Resilience increases the resistance of companies to unknown and often negative events.
Data, data, data - Take advantage of the full potential
AWK Focus (2016/10)
Never before have organisations had more extensive and insightful data assets than today - and never before have the opportunities been better to exploit this potential to the full.
Mastering Compliance Requirements with Enterprise Content Management
AWK Focus (2015/06)
Companies and organisations are confronted with an increasing number of compliance requirements in a wide variety of areas. They have to control and verifiably document compliance with more and more laws, standards and regulations. The flood of regulations is followed by the flood of documents. Enterprise content management solutions are ideal for managing this as efficiently and reliably as possible.
Change successfully
Published
Computerweek (2015/03)
Change management has contributed significantly to stabilising IT operations in recent years. In times of digital transformation, new challenges and opportunities now await.
Integral Security
Published
Network industry symposium (2014/06)
Implementation in practice
Successful process optimization in practice
AWK KNOWLEDGE (2013/12)
Companies today are subject to constant change. Examples of change triggers are changes in the market, mergers, outsourcing or even new laws and industry standards. Therefore, the management of business processes is part of the everyday life of companies today.
Requirements Engineering - decisive for project success
AWK KNOWLEDGE (2013/09)
Wherever it is a question of turning a goal into reality by means of a project, one has to deal with requirements. It is important to take into account the relevant needs of all stakeholders and the given framework conditions and to document them in a meaningful way.
DLP: For the benefit of your company data
Published
Swiss IT Magazine (2013/09)
The unlawful leakage of critical business data can threaten the very existence of a company. Data loss prevention (DLP) in conjunction with the right processes is an important component of a holistic defence strategy.
Cyber security - current trends and protective measures
AWK Focus (2013/06)
More and more services are now offered and used via electronic channels. The importance of the internet for the state, the economy and society is constantly increasing and with it our dependence on the internet as a critical communication infrastructure.
Mine your data - A way to a better understanding of the company
AWK KNOWLEDGE (2013/03)
The amount of data in companies increases on average by 40% annually. This data is mostly only used within dedicated business applications. In addition to classic application data and unstructured document collections, machine-generated data from devices and systems has also increased significantly. In the context of social media and e-business, new types of tools for data analysis and interpretation have come onto the market in recent years that do not require a data warehouse.
The leverage effect of optimized data management
Published
ICT Communication (2013/02)
The optimal management and use of data plays an important role because it is a prerequisite for efficient business processes. The professional management of master data is therefore at the top of the agenda of many IT organisations.
Data centers - successful combination of Swiss strengths
AWK KNOWLEDGE (2012/09)
In many IT organisations, data centre building services and IT systems are operationally separated, with their own specialised service providers and separate service catalogues. The operation of building infrastructures is called facility management, the operation of IT infrastructures is called IT service management.
