The last thing a pharmaceutical company wants to grapple with is a compliance violation or a security threat. When these challenges occur, they represent a frustrating distraction from the company’s core R&D mission. Even worse, the longer a company takes to resolve each issue, the bigger the hit to the company’s bottom line. Unfortunately, the pharmaceutical industry is incessantly hammered by risk and compliance management challenges. For example, the number of FDA Warning Letters issued to pharmaceutical companies more than quadrupled over a six-year period ending in 2020, according to a 2021 report from the U.S. Food and Drug Administration. The reality is that pharmaceutical companies are constantly battling issues pertaining to security, patient privacy and clinical trial regulatory compliance.
Compliance and Risk Management in the Pharmaceutical Industry
When it comes to risk and compliance management, pharmaceutical companies simply cannot fall off their wagon; the stakes are too high. The only viable way for pharmaceutical companies to gain the upper hand on this challenge is by investing in modern technology. Through digital transformation, pharmaceutical companies build the infrastructure and connectivity they need to comprehensively monitor risks and compliance violations, as well as to immediately mount an aggressive, comprehensive response that minimizes operational disruptions and financial and legal exposure. These modern technology solutions also require companies to develop workflows that impose standardization and quality control on key activities across the organization. Let’s explore five key ways that pharmaceutical companies can effectively use digital transformation to comprehensively manage compliance and risk across the organization:
Consolidate Multiple Disparate Systems
Most pharmaceutical companies have accumulated layer upon layer of systems and software and other tools. In the absence of master planning, these systems end up being disconnected from one another, and none are optimized to monitor risks and compliance issues. Consequently, pharmaceutical companies don’t have a holistic way to guard against risk and compliance violations. They maintain and update critical systems in an uncoordinated, one-off fashion and lack visibility into how these systems affect one another. Digital transformation focuses on helping organizations consolidate and unify their multiple disparate systems. Clunky, siloed legacy systems get replaced by a single, interconnected business ecosystem that is more powerful, more flexible and more scalable than anything that preceded it. Moreover, ongoing maintenance of the business ecosystem becomes much more streamlined as the organization taps into economies of scale and cost leveraging opportunities. Finally, the interconnected business ecosystem makes it much more feasible for pharmaceutical companies to collect, analyze and share data that is critical to understanding where their vulnerabilities lie.
Map Vulnerabilities to Business Systems and Workflows
Pharmaceutical companies face a wide range of vulnerabilities. Although not all of these vulnerabilities hold equal weight, the average company doesn’t have a systematic, structured way to prioritize and manage these vulnerabilities. Consequently, companies often end up taking an unfocused, haphazard approach to their risk and compliance management activities. Digital transformation gives pharmaceutical companies the tools they need to be able to understand vulnerabilities in relation to the company’s own systems and workflows. Highly visual vulnerability maps are used to help the company track every asset and resource it should be working to protect. Included on these maps are all of the monitoring and other activities being undertaken to provide this protection, plus alignment with the corresponding regulatory requirements. Moreover, these vulnerability management tools can help prioritize and focus resources on protecting and remediating the highest-value targets. These vulnerability maps also help the company develop long-term, more holistic strategies for minimizing downtimes and managing change requests, which can further reduce the overall level and types of vulnerabilities that the organization faces.
Over time, IT teams in pharmaceutical companies typically develop their own workflows and tracking systems for responding to and managing security incidents and compliance violations. These teams don’t necessarily follow best practices, making it difficult to holistically manage these issues and exposing the company to unnecessary risk. Through digital transformation, pharmaceutical companies can impose standardized, best-practices workflows for incident response. Best of all, built into these articulated workflows are numerous features that automate common tasks and steps. For example, when a critical vulnerability is identified, a request to approve an emergency patch can be automatically programmed to generate. Then, on the back end, once the patch has been applied, a follow-up vulnerability scan can be triggered to automatically initiate to verify the issue has been resolved. Through automation and standardization, IT teams’ time is no longer consumed by copious manual documentation and verification steps; instead, IT can devote more of its attention and resources to proactively managing high-priority threats and risks.
Enrich Cases with Relevant Threat Intelligence Data
When pharmaceutical companies identify a high-priority vulnerability, IT teams typically spend copious time manually researching this vulnerability, including searching knowledge-base articles and manuals on the topic. Not only is this process an inefficient use of time, but the case could begin to have real-life business impacts if not resolved immediately. Through digital transformation, pharmaceutical companies gain the toolset to automatically retrieve relevant threat intelligence and associate it with the case. These threat management tools can be configured to pull both intelligence data and write-ups from internal knowledge bases, third-party threat feeds, and other hand-selected feeds. When cases are enriched with relevant threat intelligence data, pharmaceutical companies can respond to incidents and risks with maximum authority and speed.
Streamline Evidence Management for Audits
Pharmaceutical companies invest significant resources preparing for compliance audits—not just in preparing the audit documentation itself, but also the underlying evidence that supports and backs up the documentation. This audit evidence comes from various teams across the organization. To be useful, pharmaceutical companies traditionally have been required to manually request the information from the appropriate teams, then manually process and link it to the proper financial documentation. Digital transformation streamlines audit evidence management by injecting standardization and automation into these workflows. Pharmaceutical companies use digital tools to facilitate making the initial requests for required documentation, then allow the teams submitting the information to upload it directly to the system. These digital workflows ensure the appropriate evidence for audits is available faster and with less chance of human error.
Managing risk and regulatory compliance is a complex, resource-intensive part of pharmaceutical company operations. While these challenges will never go away entirely, digital transformation can help pharmaceutical companies ease the burden—on the company’s workforce and on its bottom line. Through digital transformation, pharmaceutical companies can consolidate multiple disparate systems under one centralized business ecosystem, track vulnerabilities by systematically mapping them to business systems and workflows, require incident response workflows to follow best-practices standardization, automatically enrich cases with relevant threat intelligence data, and streamline the process of managing evidence to support audits.
Talk to Crossfuze
Crossfuze helps pharmaceutical companies to streamline and automate key processes involved with risk and compliance management. To learn more about Crossfuze’s approach to digital transformation in the pharmaceutical industry, please reach out to Crossfuze today. We look forward to working with you to stay on top of compliance and risk management in the pharmaceutical industry while minimizing time and cost.
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