What are qualification and validation

Qualification and validation are two words we use a lot in GMP, and sometimes we interchange them. This blog explains the difference between these two terms and introduces how qualification and validation help ensure compliance in the pharmaceutical industry. And just for fun, we’ll add in calibration and verification as well! Are you ready? On […]

Checklist: Transitioning from CSV to CSA

If you are starting your preparation, aim to be proactive and develop a strategy on how to transition your current CSV framework to a CSA and focus on quality assurance, patient and product safety, and data integrity. Per system, start to inventory and understand all of the following: Understand your current business and processes, resources, […]

Download our free GxP compliance checklist!

Do you want to assess whether your organisation is meeting GxP requirements? Use the below checklist and find out whether GxP fundamentals are well-established in your business and where you can still improve. If you need support, we look forward to getting in touch and finding out how we can assist in defining mitigating actions. […]

How To Write Good Technical Documents (or how to shop for groceries successfully).

Technical documents, we’ve all seen them, and many of us might have already discovered how deliciously awful they can be. This blog focuses on improving your technical writing skills for formal / technical documents like policies, standard operating procedures, and work instructions. What better way to explain technical writing tips than to look into our […]

How To Design An Aseptic Processing Isolator

This article focuses on using the 6M tool as a support of the design of an aseptic isolator. The objective is to provide a generic assessment of the machine requirements to ensure that all key aspects are taken into account, and common mistakes are avoided. Thus answering the question: How to design an aseptic processing […]

Project Management Tools in the Pharmaceutical Industry

This article focuses Project Management Tools in the Pharmaceutical Industry and shares insight into their use. The goal is not to provide a full detailed tutorial for each tool but to show their purpose and good practices for their use. And, don’t forget to download our set of free Project Management Tools here. Projects are […]