Forward-thinking organizations are automating systems so that, after initial implementation, regulatory bodies can be updated on progress quickly.

Pharmaceutical organizations are continuously striving to speed up innovation and reduce time to market throughout the drug discovery process.

Stuart Ward
Head of Business Analysis, IDBS

In an increasingly competitive market, many organizations are looking to use validated software to help them make that all-important difference—and it’s easy to see why: organizations can speed up efficiencies with regulatory compliance and decrease overall IT costs, all while helping scientists improve “good practice” (GxP) in their research. But these benefits only tell part of the story. What else is driving organizations to these validated solutions, and how can they implement them effectively?

Process Modernization

To safeguard patient safety and protect product quality, a range of regulations from organizations, such as the FDA, have been created in recent years—including regulations in software. Compliance is essential for the safety of the public, but can sometimes create headaches for pharmaceutical companies and slow down overall processes. Faced with the need to develop drug manufacturing capabilities quickly and cost effectively, regulatory compliance is being taken more seriously by organizations.

In the pharmaceutical, biotechnology, and even medical device industry, using validated systems used to be a manual and inefficient process, often plagued by delays and high costs. For most lab workers, the perception of validation is that it is a burden rather than a benefit, and compliance has been dogged with the usual inefficiencies associated with paper-based processes. However, recent developments in digital solutions have created numerous incentives for process modernization.

The creation of effective audit trails—in line with requirements from European bodies, FDA, and other industry authorities—saves time and effort. For software providers, capturing this data automatically can be used to increase efficiencies around ensuring the captured data is complete and correct. Meanwhile, forward-thinking organizations are automating systems so that, after initial implementation, regulatory bodies can be updated on progress quickly and provided with the necessary information in the required format.

To ensure automated data is captured smoothly and accurately, organizations need to modernize their pre-existing IT systems. While paperless validated systems have been available for over a decade, the pharmaceutical industry has come a long way from the basic functions of document management and sharing, as software now enables organizations to automate systems and workflows, and integrate with change management.

To fully realize the benefits of validated systems, firms must embrace the evolution of their core IT systems, including considering a move to the cloud.

Reaching for the Cloud

Most organizations are already using cloud-based services in some form or other—and the cultural changes needed to make the transition successful are far easier to navigate than they were just a few years ago. Although there is a school of thought that data should only be kept “in house,” generally, these concerns are not well founded.

The reality is that Software-as-a-Service (SaaS) providers running on a cloud infrastructure provide users and organizations with robust data security. These include access to resilient and monitored security systems, regular backups, the provision of test environments, and easily scalable servers to match system demands. A cloud model also means organizations can pay for what they use, and removes the need for customers to build, monitor, or upgrade the product—reducing the total cost of ownership.

For those pharmaceutical companies who require GxP systems, using a cloud solution will enhance and assist their validation experience, putting them in a better position for regulatory requirements and risk assessment decision-making. In fact, the benefits of this kind of solution include having a fully managed, documented, time-stamped and accredited trail of activity, and that parts of the validation process can be automated, meaning upgrade cycles of five-plus years is a thing of the past.

Embracing the Potential

The FDA, and other regulatory bodies, encourage the use of modern pharmaceutical development concepts, risk management, and quality systems at all stages of the manufacturing process lifecycle to ensure compliance. Implementing systems that can be easily validated improves an organization’s productivity and guarantees it remains compliant, while simultaneously cutting costs and increasing efficiencies.

A cloud-based approach offers an easy way to quickly access, and start benefiting from, software that can be used for regulatory purposes. With the potential to integrate the Software-as-a-Service model smoothly into a GxP regime and to scale up more easily, these solutions will continue to revolutionize compliance for research organizations.

We forget how much we rely on software to achieve our daily work. Taking advantage of the latest technological advances, and the potential of the cloud, will ensure scientific research organizations continue to beat expectations, and conform to existing or future regulations.

About the Author:

Stuart Ward has served as Head of Business Analysis at IDBS since the start of 2014. Prior to that, he was a Product Manager, Principal Consultant, and Team Leader responsible for the configuration, deployment, strategy, design, and delivery of IDBS’s E-Workbook Suite.