Insights
The latest thinking, advice, and expertise from the Westbourne team
A New (Science-Led) Approach to IT and Technical Support for the Pharmaceutical Industry
Digital transformation concepts and new technologies are changing the pharmaceutical industry, from individual processes in labs and on production lines to the way businesses operate. With technologies being at the center of these transformational changes, it is...
Westbourne is Now an Approved ValGenesis Partner
We are delighted to announce that we are now a ValGenesis partner. ValGenesis is the developer of a suite of digital validation and process lifecycle management tools used by pharmaceutical companies across the globe. John O'Sullivan, Westbourne Founder and CEO,...
Risk-Based Approach to Reviewing Data and Audit Trails in Empower 3
Audit trail data is essential for compliance, and it has operational benefits. Regulators, including the FDA and European regulators, publish guidance that outline the parameters for maintaining audit trail data. Systems like Empower 3 provide the required...
Identifying and Mitigating the Risks and Challenges of Pharmaceutical Digital Transformation
Digital transformation projects and initiatives deliver considerable benefits to companies in the pharmaceutical industry. Digital transformation modernizes operations, improves efficiency, reduces costs, and enhances patient safety and quality. Digital transformation...
Continuous Oversight: a Key Principle for Implementing AI in Pharmaceutical Manufacturing and Quality Control
Artificial Intelligence (AI) is one of the hottest topics in business right now as executives try to take advantage of the potential benefits. In many respects, the pharmaceutical industry is no different, with the potential of AI in R&D looking particularly...
Empower 3 Audit Trails and Logs Explained
In the context of the computerized systems used in GxP environments, audit trails are a chronological record that captures all actions and events related to data. As a result, audit trails are a key area of functionality in most laboratory applications, including...
17 Features You Need in a Global Service Desk
In today's digitally connected world, a global service desk is more than just a support function. It’s the backbone of seamless operations, uninterrupted service, and exceptional user experiences. Choosing the right global service desk provider is a pivotal decision...
A Complete Guide to Computer System Validation
Computer System Validation, or CSV, is a modern, risk-based methodology that confirms software used in pharmaceutical operations functions as intended. The risk-based approach is based on critical thinking. CSV has applied to the pharmaceutical industry for many...
Why Multidisciplinary Skills Are Essential in Pharma Lab and Manufacturing Operations
Very specific skills are required to successfully, safely, and profitably run a pharmaceutical manufacturing and laboratory operation. We are in an era of change, however. This means skills requirements are also changing, with multidisciplinary skills coming to the...
How On-Site IT Engineers Become Enablers in Your Organisation
There are many technical issues and tasks that can be supported by remote teams. Others, however, require the physical expertise of on-site IT engineers. On-site IT engineers shouldn't be viewed simply as resources performing specific functions. When set up properly,...
The GxP Implications of Windows 10 End-of-Life for Pharma Labs
Windows 10, the commonly used operating system in pharmaceutical laboratories, is reaching its end-of-life (EOL). The EOL deadline, imposed by Microsoft, has significant operational implications for companies in all sectors and industries. In the pharmaceutical...
Technology-Focused Scientific Career Progression Pathways in the Pharmaceutical Industry
The pharmaceutical industry is changing with the introduction of advanced methodologies and the greater use of new technologies. These changes are taking place in all parts of the pharmaceutical industry, including in laboratories and on the factory floor. As a...
Maximizing Pharmaceutical Digital Transformation ROI
Digital transformation is changing the way pharmaceutical companies run their businesses, manufacture products, and develop new therapies and treatments. These changes are positive, but it is essential that modernization initiatives are justified by maximizing ROI....
Understanding Process Validation in the Pharmaceutical Industry
Process validation is all about two essential requirements for manufacturing in the pharmaceutical industry: consistency and reliability. Deviations in the consistency or reliability of manufacturing processes result in sub-standard pharmaceutical products that can...
Digital Transformation Cybersecurity Considerations in the Pharmaceutical Industry
Companies in the pharmaceutical industry cannot stand still, so modernizing through digital transformation is essential. It is also a fact that companies in the pharmaceutical industry are high-value targets for malicious actors and cybercriminals. This cybersecurity...
Career Progression Pathways in the Pharmaceutical Industry for IT Engineers
IT engineers can work in a range of different industries – just about any industry you can think of, in fact. One of the most exciting and rewarding, however, is the pharmaceutical industry. Why? You can future-proof your career in the pharmaceutical industry. There...
IT Support On-Site – How to Choose the Right Solution for Your Business
Most businesses require some level of IT support, from full support to augmenting in-house technical teams. While there are different types and levels of IT support, most fall into two main categories: remote and on-site. In this blog, we are focusing on IT support...
The Convergence of Science and Technology Expertise in the Pharmaceutical Industry
Pharmaceutical laboratory and manufacturing operations are changing. The implementation of business process automation solutions and digital transformation initiatives are contributing significantly to these changes. Changing regulatory requirements, market demands,...
Digital Transformation in the Pharmaceutical Industry
Digital transformation in the pharmaceutical industry involves digitalizing processes in your laboratory and manufacturing operations. It is about more than digitizing elements of a process to enable work on a screen rather than on paper. That is part of it, but...
Case Study: Empower CDS Validation and Wider Validation Improvements
Introduction Pharmaceutical laboratory operations are becoming increasingly reliant on technology as new platforms are implemented, systems are integrated, and processes are automated. This digitalization drive is delivering a range of benefits, from quality and...
Ensuring GMP Compliance with Lab IT Infrastructure and Systems
Continuous improvement is an essential priority for pharmaceutical manufacturers. This push for continuous improvement is one of the reasons companies invest in their IT, including lab IT infrastructure and systems. As a result, more and more processes and workflows...
Virtualization in a nutshell
Traditionally, IT infrastructure was physical, i.e., physical servers in an on-site server room, physical desktops on each lab technician’s desk/workstation, etc. Virtualization technologies create virtual representations of these previously physical IT infrastructure...
Audit Trails in Lab Environments – Overview and Best Practices
Audit trails are an essential component of regulatory compliance in the pharmaceutical sector. They are also crucial for ensuring patient safety as well as delivering a range of other benefits. There are two main types of audit trails that apply to pharmaceutical...
Pharmaceutical Digital Transformation
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Pharma Lab and Manufacturing
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On-Site ICT
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Validation
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Global Service Desk
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