A Swiss-based international consultancy with a focus on SAP ERP/IT projects and csv support in the Pharmaceutical, Medical device and Chemical industries...
Our exclusive focus on key business processes across the Pharmaceuticals, Biotechnology / Biopharmaceuticals, Medical device / Scientific instruments and Chemicals industries makes us a valuable partner for your IT projects.
Whether these are complex Divestment scenarios, smart tailor-made SAP ERP product solution integrations, Track&Trace implementations or Computer Systems Validation our consultants have deep and extensive understanding of the specific business needs and requirements so they are able to propose and implement the most feasible, robust and viable solution.
Whether these are complex Divestment scenarios, smart tailor-made SAP ERP product solution integrations, Track&Trace implementations or Computer Systems Validation our consultants have deep and extensive understanding of the specific business needs and requirements so they are able to propose and implement the most feasible, robust and viable solution.
International Project Experience
With offices conveniently located in Europe , we are able to accommodate all time zones and have so far supported multiple projects around the globe – both national and international in nature. Supporting the divestment of sites, core or local systems implementations, as well as Validation activities for producing organizations, laboratories and the authorities is our main focus.
i(nsight)2b
i(nsight)2b will bring you insights and news about implementation strategies, CSV methodologies and interesting insights around new technologies, platfroms and more. Here we will share our latest insights from within the Pharma, Biotech, and IT industries.
Rethink-TMRW_Insight
Rethink: TMRW
An annual summit about the future of track and trace solutions and holistic digital supply chains. Powered by our partner Movilitas we support this conference 10-11 Oct 2022 in Frankfur...
Read MoreGxP and Scrum Insight
GxP and Scrum in the Pharmaceutical Industry
In the pharmaceutical industry, which is highly regulated, strict rules apply in all its sectors, including the computer system projects. Such rules are ...
Read MoreComputer System Validation and Climate Change
Recently, many businesses have made serious commitments to address their own actions to contribute to climate change. Focusing on sustainability in business models and corporate governance can give bu...
Read MoreValidation for the Cloud Insight
The pharmaceutical sector's information technology requirements are following industry trends, forcing a transition to cloud computing. But how does this affect your validation efforts? Click here to
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Read MoreThe Pharma Industry is turning to blockchain technology – are you prepared?
We covered the recent emergence of Blockchain technology as well as the challenges it presents to the validation activities, but can this technology transform a more “traditional” organization like a ...
Read Moreinterviewing2b: Regular V Model Computer System Validation, is this still feasible?
Computer system validation has been getting increasingly complex and with a growing number of details required, while often the validation effort overshoots the implementation or development work spen...
Read MoreBlockchain technology & Computer System Validation – what is the impact?
Blockchain technology was introduced over a decade ago, and now it is not only used for cryptocurrency platforms, but it has also evolved into something more significant with the ability to change the...
Read MorePaperless Computer System Validation (CSV)
In the regulated industries there is the saying “what is not documented is not done”. And in numerous regulated industry organizations, the de facto method of documenting the work being done is almost...
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