Microsoft Word is a widely utilized tool for creating and editing regulatory documents. However, its full potential is often overlooked. In this Insight, Principal Medical Writer Katja Heinemeier provides 5 Microsoft Word Hacks for regulatory writers to increase writing speed & efficiency.

In this Insight, Jakob Juul Rasmussen highlights the recently released EMA Guideline on computerised systems and electronic data in clinical trials. The Insight includes a high-level overview of what’s included in the new guidance and background context for its adoption.

Equipment Qualification is critical in the pharmaceutical industry. In this Pharma IT Insight, Rojan Demirtas provides a high-level description of the equipment qualification process, the expertise required to do it successfully, and the biggest challenge facing the life sciences industry’s ability to do so.

Omnichannel Marketing is a key trend within the commercial pharma space. For this Insight, we sat down with Director of Commercial & Medical Systems, Martin Rother Breyen, to learn more about what it is, why it matters, and how to use it!

The Pharma IT Academy recently hosted Sion Wyn for an exclusive event highlighting the new GAMP5 Second Edition. In this Insight, we recap the event and provide 3 Key Takeaways.​

The Pharma IT Academy recently hosted Sion Wyn for an exclusive event highlighting the new GAMP5 Second Edition. In this Insight, we recap the event and provide 3 Key Takeaways.​

From January 31st, 2023, it will be mandatory to use Clinical Trials Information System (CTIS) for the submission of clinical trial applications (CTAs) and for documents related to the maintenance of the clinical trial authorisation for clinical trials in Europe. In this insight, Principal Consultant Lena Brahe briefly describes the CTIS, and then focuses on the Investigator’s Brochure and explains the implications sponsors should be aware of following the requirement for public disclosure of information submitted to CTIS.

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.