Martin Willer provides a guide to choosing the right expression system for heterologous protein production. Every expression system comes with a unique profile of strengths and weaknesses that should be considered, including both qualitative and quantitative parameters. This includes the factors you should consider and why it is important to plan your documentation process from the very start.

The EU’s new Clinical Trials Regulation (CTR) is now live! This Insight briefly describes the purpose of the new regulation and shares 5 important considerations for clinical trial sponors.

Testing and validation are a central component of ensuring the security and continuity of computerized systems. For this reason, automation of testing efforts is an important aspect of an overall automation strategy. This Insight outlines the benefits of test automation and discusses how Selenium can be used to automate processes, like regression tests in Veeva, which have traditionally been done manually.

DevOps has become a bit of a buzzword, its use in practice is often too vague. To demystify the topic, this Insight examines DevOps from a technical perspective. By viewing the concept through the lens of Cloud Computing and Infrastructure as Code (IaC), a fuzzy DevOps concept becomes much more clear.

Ensuring compliance with the European Pharmacopeia (Ph. Eur.) is a cornerstone of European GMP compliance. This Insight highlights the importance of monitor coming changes in the pharmacopeias, and highlights the latest revised general monograph 2.2.46 Chromatographic Separation Techniques.

Pharma IT Consultant Sara Hamilton discusses the important highlights of two reports published in late 2021 which are relevant and informative for improving compliance in pharmacovigilance.

Stig Ragborg highlights why you may want to take a step back to take the right leap forward in your Digitalization for Labs of the Future (LoTF) process. Keep reading to learn more about what you should consider during this process and why you shouldn’t overlook the basics.

Pharma IT Partner, Jakob Juul Rasmussen, highlights the client case of Ascelia Pharma which recently went live on the Pharma IT Cloud EDMS+QMS platform – a secure, and fully GxP-compliant EDMS+QMS solution.

Senior Consultant, Martin Blædel, highlights the latest changes in the guidance on quality of water for pharmaceutical use, as well as their implications for pharmaceutical manufacturing.

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.

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.

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.

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.

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.

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

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.