Vaccinating the world: The important role of cloud QMS

Sophie Willink Date published: Dec 09, 20

Digital technology has rapidly enhanced and streamlined business processes for many organisations, yet quality management functions are often slow to move away from manual process to a cloud QMS. Many quality management functions still rely on traditional spreadsheets or even manual, paper-based systems. This approach to quality management is not only lacking in competitive edge, but it can actually hinder an organisation’s efficiency. Using paper-based systems for core business processes such as document management, audit management, incident reporting and project management often results in repetition of work, lack of ownership and inefficient use of time.

Moving away from these tired manual processes to a cloud-based quality management system should be a priority for business leaders. Cloud QMS has considerable business benefits for every organisation that operates within a highly regulated industry and is an integral aspect of operational excellence.

Without the implementation of cloud QMS, establishing global visibility and collaboration would not be possible. Here, we examine the timely example of the key role it played in supporting vaccine trials to ultimately find a way out of the global Covid-19 pandemic.

Cloud based quality management systems and the Covid-19 vaccine

Many of the organisations that Ideagen support are involved in the response to the COVID-19 pandemic, giving us an insight into their need for highly efficient business processes and integrity of data.

To date, the pandemic has resulted in over a million deaths and caused global economies to standstill. Ending this unprecedented global crisis depends on the rapid development and deployment of effective vaccines.  

The fastest time period a vaccine has ever previously been developed in was four years – most can take 10-15. Full utilisation of cutting-edge technology was required to speed this process up to under a year, without sacrificing quality in any way. Moving away from traditional manual systems to a cloud QMS allowed scientists to collaborate internationally, ensure data integrity, and maintain quality and adherence to regulatory standards at each stage of the process. This rapid global response would not have been possible using traditional document and quality management systems, nor would it have been scalable to the significant extent that is required.

We look at some of the compelling benefits the utilisation of modernising document management and cloud QMS will have provided:

Secure document collaboration

Secure document collaboration is a key aspect in facilitating speed and scale, and supports the process by allowing organisations to:

• Complete large-scale reviews of regulatory documents in less time
• Produce high-quality content for emergency use authorisations, investigations, and submissions
• Have tighter control over personally and commercially sensitive data
• Collaborate in real-time with 3^rd parties in a secure environment
• Audit the history of a document’s lifecycle to support QMS processes

Maintaining quality in the race for a Covid-19 vaccine:

Cloud QMS supported – and will continue to support – the response at each stage of the vaccine process:

Clinical trials:

• Ensure patient safety through clinical trials
• Streamline the clinical trial process to decrease costs and burden
• Provide a consistent quality framework making it quicker and easier for regulatory authorities to evaluate and measure
• Fewer study delays to accelerate the products’ time to market

Manufacture:

• Increase visibility across the supply chain
• Easier internal communication
• Improved ability to solve repeated quality issues
• Compliance with industry standards
• Improved product assessment

Deployment:

• Support safety in airports as they get ready to receive and store large quantities of the vaccine
• Ensure unity across the entire supply chain
• Assessment of equipment (e.g. sterile needles) for health professionals to administer vaccines to entire nations
• Also ensure their compliance with regulatory standards

At this moment in time, the leading vaccine producers have either just received regulatory approval or are at the point of applying for regulatory approval. This is an essential step that ensures the vaccines work correctly and are safe to use. However, it is critical that this step does not dramatically slow the vaccine’s time to market – and it does not have to.

The UK was the first country in the world to approve a Covid-19 vaccine for public use, made possible by the “rolling review” throughout the trial. Given all of the leading organisations’ commitment to using cloud QMS throughout the clinical process, the regulatory board’s job will be eased with full access to high quality data, demonstrable compliance to regulations throughout and comprehensive audit tracking.

For organisations that have not already embraced a modernised approach to QMS, the unprecedented results seen in response to the Covid-19 pandemic should demonstrate the remarkable achievements that can be possible with the correct tools in place.

Find out more about how Ideagen’s cloud QMS can support your organisation to increase its business efficiency and improve organisational performance.