The key to good end-user training for eQuality Management Systems
We all know that training plays an important part in the Quality area. It is the responsibility of the Quality department to ensure that employees are properly trained to ensure all regulatory compliance. When you implement an electronic Quality Management System (eQMS), training is even more essential because effective training will guarantee that people are able to follow the processes to support the defined quality rules, which will assure product quality.
Key Factors when selecting an electronic Quality Management System
There are many approaches to achieve top-notch Quality Management for the pharmaceutical industry: paper or electronic, on-premise or hosted, and one-time purchase or a subscription model. Plenty of software suppliers have offerings pre-configured to support your quality processes. To wade through the different options available, the checklist here can provide some guidance or even new ideas to think about when implementing a system to help manage Quality records.
“Data Discernment – A simplified approach to strategic study and portfolio planning.”
Historically, clinical outsourcing has negated the need for small-to-midsize Sponsors to maintain their own in-house Clinical Trial Management System (CTMS) application. With the evolution of adaptive protocol design and the increased importance of capturing, synthesizing and operationalizing on-going data points over the course of a study – to drive protocol amendments, risk-based study management, or acquisition/divestiture decisions – many Sponsors want more involvement and control in their study data, regardless of the outsourcing model.
DIA Conference Summary ’21
This year‘s DIA Annual Conference seemed to focus on how the COVID-19 pandemic propelled forward the development and utilization of technology to support patients, from recruitment to trial execution.
Why Do You Need an Electronic Quality Management System (eQMS)?
This question is one of the most asked during my last 3 years practicing as a consultant in the life sciences industry. Here is how I respond to the most common objections, explaining the multiple benefits clients can take advantage of when working with an electronic Quality Management System (eQMS).
Managing CRO Sponsor Compliance in Veeva Vault Clinical
The main lesson learned from ourfirst blog post in this series on best practices with Veeva Vault Clinical – keep it simple. Know the work to be done in the environment, take ownership and roll out the “welcome mat“ for your users by configuring the application to reduce the noise and minimize the learning-curve confusion of unnecessary features.
Reducing the “noise” – How to tailor Veeva Vault Clinical to your individual needs
Have you ever bought a cool, new gadget with all the bells and whistles, only to find that you're not using it to it's full capabilities? Well, this is can be a challenge for Veeva Vault Clinical customers, as well! Vault customers often come to us with an out of the box environment with such a broad range of powerful features, that the system goes underutilized. Here's how we suggest to mitigate...
Building an Agile Object and Security Model – Step by Step
This blog post describes how to build an agile object model and enhance it with a solid security model that fits most of the companies needs and even supports future expansion.
AWS Sumerian as Quality Training – Digital Learning in the Enterprise
Employee further training is nowadays one of the key challenges various industries (education, energy, medicine & health, manufacturing, etc.) are facing. As opposed to the past, when all training took place on paper, today learning can and should take advantage of computer-based, interactive technologies - to put it simply: digital learning.
My journey through Life Sciences
My passion for Life Sciences began when I started my apprenticeship at an old-established pharmaceutical company based in Cologne as data processing specialist.
Keep Talking: Why Communication Is the Key to a Successful Project
The success of a project often comes down to one thing: communications. In our experience, far too many projects fail to meet milestones, miss objectives and goals, or end up costing far more than originally anticipated, simply because clear communications weren’t established right from the start of the project and carried through.
Veeva R&D Summit Puts Focus on Innovation and Best Practices
For those of us on the services side of the life sciences industry, connecting with industry clients and colleagues is crucial to ensure changing needs are addressed. The 2019 Veeva Global R&D Summit, held in Philadelphia from 8 to 10 September, was a golden opportunity to connect with industry leaders, hear about pain points and advances in areas such as regulatory information management (RIM), and share common objectives.