Equipment Qualification in Pharma

Displays the title of the Pharma IT Insight as well as a background image showing an example of Pharmaceutical Manufacturing Equipment that could be validated.

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 in Pharma with Martin Rother Breyen

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!

3 Key Take Aways from the New GAMP5 Second Edition

Banner Image showing a snapshot of the crowd and Sion Wyn, Editor of the GAMP5 Second Edition at an event hosted by the Pharma IT Academy

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.​

Increased disclosure of clinical trial documents following the EU Clinical Trials Regulation (CTR)

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.

Choosing the Right Expression System for Heterologous Protein Production

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.

Top 5 Considerations for Ensuring CTR Readiness

An image of a clinical scientist in a lab setting, overlaid with the text "5 Considerations for Ensuring EU CTR Readiness"

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.

Automated Testing of IT Systems in GxP environments with Selenium

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.

What is DevOps? Understanding Cloud Computing and Infrastructure as Code (IaC)

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.

Importance of European Pharmacopeia Monitoring for Lab GMP Compliance

Importance of European Pharmacopeia Monitoring for GMP Compliance

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.

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