It’s easy to see why pharma is one of the most highly regulated industries. According to BMJ, more than 237 million medication errors are made in England every year, resulting in losses exceeding £98 million and over 1,700 lives. With the widespread misuse of medications, it’s particularly important for pharma companies to follow regulations that ensure their drugs are safe for public use.
The need for such exact compliance means that companies face the challenging task of satisfying a number of regulations across all aspects of their business. On top of the saturated regulations that govern the industry, compliance is also constantly changing as the industry grows. With increasing regulatory mandates, intense pressure on pricing, and ever-adapting technological advancements, pharma companies must change their compliance processes to align with their business strategy, accelerate speed to market, and improve customer satisfaction.
Organisations have long relied on manual processes to ensure compliance, largely due to the complex nature of operations in the pharmaceutical industry. Sufficient compliance demands that companies must cover a number of areas, including human resources, foreign corruption, patient assistance programs, regulatory bodies reports, and communication with patients and healthcare professionals. Between the need for specialised expertise in each of these areas and the dependence on several distinct parts within an organisation, it can be challenging for pharma companies to stay ahead of regulations and deliver their products to the market quickly.
On the other hand, digital transformation can help pharma business leaders stay ahead of regulations and streamline the process. Here are a few ways technology can support regulatory compliance in the pharmaceutical industry.
According to Gartner, 40 percent of a pharma company’s IT budget is spent on regulatory compliance. Like businesses in other industries, pharma companies must implement automation in their processes to cut down on costs and facilitate more efficient operations. By replacing many of the manual tasks professionals must normally prioritise due to regulation, pharmaceutical companies can not only be more efficient, but also respond more proactively to changing compliance rules.
One of the most important things automation can help with is the coordination of data across various functions and departments. As teams work closer together, they are able to share and reuse critical data without potentially mishandling or losing it. The protection and management of data are not only essential to the success of R&D development stages but will also ensure that pharma companies remain compliant and gain approval from regulatory organisations as quickly as possible.
Similarly, manual and repetitive tasks related to regulation—such as reviews, documentation, and submissions—can weigh down the drug approval process. Automation allows these tasks to be completed by bots with oversight from professionals, allowing pharma companies to spend more time on completing strategic tasks, developing new capabilities, and allocating resources where they most need it. Instead of rushing to respond to threats to compliance after hearing from the FDA, business leaders can distribute resources to teams who proactively make compliance a priority in all of their decisions. And in the competitive pharmaceutical market, every small change in efficiency can make your company stand out from the competition.
Pharma operations require collaboration between all areas of a company, and many of them are limited by manual processes and disparate systems. For example, compliance officers have long had to maintain paper records of the operations, employee compliance training, and policies within their company in case of a situation in which they had to prove they had remained compliant throughout the development process. These traditional processes can lead to a variety of potential roadblocks, from losing important documents to forgetting to document the training of employees. They have also made it difficult for other teams who need access to the same information to access it, leading to slower and less efficient operations.
By using one platform to consolidate all systems and processes, however, compliance officers no longer have to worry about misplacing important information. With the use of a single cloud platform, business leaders can simplify the management of large clinical trials, share important information across teams and locations, and integrate existing systems to ensure data is reliable and reusable—regardless of its source.
Not only does the consolidation of data make research and development processes run smoother and help companies deliver quality products, but it also ensures and proves compliance with regulatory requirements whenever necessary. In the event that your company makes a mistake in following regulations, it is essential to have as much proof that you have followed compliant protocol as possible. By using a single platform, you ensure that this information does not get lost and is easily accessible in the case of an emergency.
Compliance can vary significantly between industries. The pharma industry has its own challenges, and companies need solutions that target their specific roadblocks. Rather than using a wide range of generic technologies to solve their problems, pharma companies need to search for industry-specific solutions that allow them to coordinate their processes, store important data, and streamline the R&D process—all under one platform. The more industry-specific your solution is, the more capable it will be at addressing your problems and providing long-lasting success.
The Now Platform addresses the industry-specific challenges that pharma companies face. By consolidating multiple systems into one platform, driving more effective collaboration across involved parties, and removing relevant roadblocks, this solution allows companies to shorten the development cycle and accelerate speed to market. Throughout R&D development, pharma businesses can rely on the Now Platform to shorten the development cycle and help them remain compliant. Additionally, ServiceNow exemplifies constant improvement, which means the Now Platform will continuously innovate to provide the best solutions for the pharma industry.
Crossfuze and ServiceNow deliver tailored transformational solutions for optimised digital processes. We strive to help pharma companies drive efficiency within their organisations with Pharma 4.0 operations. With compliant, customised solutions, we ensure that every company maintains compliance throughout the R&D development process. For digital transformation that lasts, reach out to us at LetsTalk@Crossfuze.com.