The Latest Update on WFI and Sub-Visible Particles

The regulatory environment surrounding the pharmaceutical industry is constantly evolving. In this insight, Pharma IT’s Director of Chemistry, Manufacturing, and Control (CMC), Torben Elhauge, highlights two significant Pharmaeuropa developments you should be aware of.

Validation of IT Systems Used in Clinical Trials

Regarding the outsourcing of clinical trials, the relationship between sponsors and their Contract/Clinical Research Organisations (CROs) is a complex one. This insight, provides a useful tool that can be used as a guide for sponsors looking to ensure a CRO’s IT Systems are compliant.

RPA in Pharma: Use-cases and Value

In this article, you will learn how RPA technology can be used in the Pharmaceutical and Biotech industries to drive value, optimize processes, and reduce risks. Furthermore, we will also provide examples of use-cases and show how you can get started with RPA quickly and efficiently.

Ensuring IT Compliance for Outsourced Clinical Trials

Since sponsors of clinical trials are ultimately responsible for the validation and provisioning of adequate documentation for computerized systems, thinking about computer system validation early on is a great way to ensure compliance and mitigate risk. In this Insight, we share 3 tips on optimal initial steps when conducting audits and approvals of CROs.

Interview on the Future of CSV with Jeppe Amossen

Computer System Validation (CSV) is currently undergoing rapid change – not least due to the advent of large-scale automation. We’ve had the chance to ask Senior Consultant Jeppe Resen Amossen about the future of CSV and Test Automation, including risks, benefits, and potentials.

Only 128 days until EU MDR: Here’s Five tips on how to get ready

Pharma IT Insights Only 128 days until EU MDR: Here’s five tips on how to get ready By Per Andersen January 19, 2021 Pharma IT Insights Only 128 days until EU MDR: Here’s Five tips on how to get ready By Per Andersen January 19, 2020 ← Back to insights Share on email Share on …

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Software as a Medical Device

Software is increasingly becoming the go-to method for diagnosing illnesses and monitoring health, creating challenges concerning new and updated legislation such as the EU MDR.

Automated UI Testing

Automation of User Interface (UI) testing has matured significantly in recent years, and through the use of no-code tools, UI test automation is now accessible for a broader audience.

Why Devops and SAP ATTP should go hand in hand

Since 2016 all pharmaceutical companies have implemented solutions to support Serialisation requirements from different markets.  I have been involved in implementations at 3 different clients. The question i receive most often is how to transition from a successful implementation to a more stable operation of SAP ATTP, without keeping the project team around indefinitely. I …

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Will IDMP submissions become mandatory in Q4 2022?

The EMA SPOR (ISO IDMP) Task Force is continuously working on implementing the ISO IDMP standard. According to the EMA Substance and products data management services page the following apply: Product and substance data preparatory phase is ongoing and started after the launch of the RMS and OMS in 2017 Next phase is the “Product …

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