Frequently Asked Questions

Where to start is one of the most challenging elements for pharmaceutical companies looking at digital transformation. Our approach at Westbourne is to conduct an assessment that includes your IT infrastructure, operation technology environment, and current workflows and processes. We'll then provide advice and recommendations on the next stages of your digital transformation journey with objectives that include minimising risks, establishing a foundation for future success, and delivering tangible results.

There are compliance risks with digital transformation just as there are compliance risks with any IT or infrastructure project in pharmaceutical organisations. However, not only can those risks be managed, you can also reduce overall compliance risks through digital transformation by modernising processes, increasing automation, integrating systems, and utilising new technologies.

Manual systems, whether digital or paper-based, can and do work well in pharmaceutical laboratories. However, they are resource-intensive and time-consuming. There is also a high risk of human error, plus it is easy for data  to be incomplete or become compromised or lost. Modernising your systems and processes will improve data accuracy, completeness, and availability, while also  reducing compliance risks and enabling you to reallocate your resources to more value-adding tasks.

There are a number of elements that ensure the successful implementation of optimised processes and new technologies. This includes getting a full understanding of your current processes and technologies. One of the most important elements, however, is engaging with laboratory staff throughout the entire process.

We have well-established processes and experienced managers who work closely with our engineers placed at clients sites. The engineers allocated to your facility will remain in constant communication with your team. They will also provide reports with information on IT system performance in addition to updates on regular tasks, ongoing projects, and new recommendations.

We strive to deliver the highest standards of service quality with a focus on the requirements of your business and a commitment to continuous improvement. There are two other areas that set us apart. The first is the fact our solutions are delivered by experienced and qualified engineers. The second is our expertise providing on-site ICT solutions to pharmaceutical industry customers.

In brief, CSA builds on traditional CSV processes. It shifts the focus away from documenting everything from scratch to an approach that is based on risks. This reduces the time involved in validating computer systems while also improving safety and quality. Documentation is still required, but there is a greater emphasis on computer systems that represent the highest risks to safety and quality.

Our validation engagements with pharmaceutical industry clients often involve a training element. This especially applies when we have created new or updated validation master plans, templates, and/or SOPs. All training will be tailored to your processes, workflows, and personnel.

Monitoring and reporting are crucial elements of our Global Service Desk solutions, so we will provide you with information on common metrics such as uptime, ticket volumes, and ticket response time. We also place significant emphasis on user experience to ensure users are as happy and productive as possible.

Reducing the number of tickets being submitted will make your IT function more efficient while also improving the experience of users. There are several strategies that we can use including conducting a health check of your IT infrastructure, providing staff with training, and taking a proactive approach to solution delivery where we seek to identify and rectify issues before they occur.

Automating integration with robust SOPs is the best starting point for avoiding data integrity issues in chromatographic integration. It's also important to identify the right method as the method is sometimes the problem rather than the integration. Automating calculations will also help ensure data integrity.

Most commonly used CDS platforms, including Empower CDS, offer a range of configuration options that can be adapted to meet your requirements. This includes implementing the CDS on a single workstation in your lab or on a network, with the latter option giving authorised users access to the CDS from multiple workstations in the lab and, potentially, elsewhere in the facility, at different company locations, and remotely. Implementation solutions can also often be either on-premises or in the cloud.

The simple answer is yes, although the reality lies in how the LIMS platform is implemented, managed, used, and supported. For example, many laboratories only use a percentage of the capabilities that are available because workflows haven't been adjusted and staff haven't been sufficiently trained. Your LIMS platform also needs to be properly configured to match your workflows and laboratory requirements.

Even at a basic level, implementing a modern LIMS platform in your laboratory will improve performance. However, you will maximise ROI by ensuring the implementation is properly managed and users have access to high-quality ongoing support.

Most laboratories, including small laboratories, can benefit from implementing a LIMS platform. A LIMS platform reduces the risk of human error, streamlines processes, and improves productivity. The key is getting a LIMS solution that can be adapted to your requirements. This involves selecting the right LIMS vendor and working with an integration and support partner who can configure and validate the LIMS installation and then provide your team with ongoing support.

There are a number of tasks performed by laboratory teams that can be categorised as non-scientific and/or non-laboratory work. Data collection and recording are two examples, in addition to ensuring data integrity. Performing these tasks manually takes up valuable time and resources, and creates significant scope for human error. Technologies and automation solutions free up resources for laboratory and scientific tasks while optimising compliance processes and eliminating the risk of human error.

Data integrity controls are about ensuring your organisation's data is accurate, consistent, and reliable, and they are essential for regulatory compliance. Following ALCOA+ principles is an effective approach to implementing data integrity controls. In ALCOA+, data should be:

• Attributable - the source of the data and the date and time should be recorded
• Legible - able to clearly read and understand the data
• Contemporaneous - data is recorded at the time an action takes place
• Original - data records should not be transcriptions or copies
• Accurate - data should reflect what happened and be free from errors and editing
• Complete - nothing should be deleted, missing, or lost
• Consistent - data should be chronological
• Enduring - data should always be available in the future
• Available - data should be accessible

Training has always been important to us at Westbourne, and we regularly train our technical resources to enhance their capabilities, adapt to new ways of working, and follow industry best practices.

We also identified a growing need in the pharmaceutical industry for staff with both scientific and technical skills, whether that is scientific staff with technical skills or technical staff with scientific skills. As a result, we established a Pharma Lab Apprenticeship initiative to enhance the scientific skills of our team, complementing our technical training initiatives.

Furthermore, we continue to expand our scientific and operational technology capabilities through recruitment.

Absolutely. While we offer unique solutions to pharmaceutical organisations, our managed services solutions can be adapted to meet your specific requirements. We have experience working with companies across a broad range of industries, and our quality standards are second to none.

Consistency is important when placing staffing resources, especially in highly regulated and demanding environments like those in the pharmaceutical industry. While we can’t make 100 percent guarantees, we will do everything we can to ensure staffing remains consistent.

We understand that staffing, skills, and resource requirements can change for a number of reasons. Therefore, we will work with you to adapt our services to suit your changing needs.

There are a number of areas we will look at to ensure your IT spend is as optimised as possible. This includes assessing licences and subscriptions you are currently paying for and negotiating with vendors wherever possible. We'll also look to implement technology solutions that will automate expensive manual processes, as well as developing strategies that take into account your needs tomorrow in addition to today.

We can tailor the level of support we provide according to your requirements. This can include anything from support in specific areas working alongside your team to managing the entire project from planning to delivery to post-implementation support.

We have extensive experience providing training to companies in the pharmaceutical industry, including on the Empower CDS platform, CSV processes, and technical skills. Furthermore, the solutions we provide aren't just theory as we also work directly with pharmaceutical companies providing managed services as well as global service desk, validation, and digital transformation solutions.

Yes, we'll tailor the training according to your needs as a business and the learners that will be involved. This could be beginner training for those with little knowledge of the subject, or more advanced refresher training. We can also provide training for staff with intermediate and advanced skills.