3 Practical Ways to Improve Infrastructure Agility in Pharma

The COVID-19 pandemic has taught pharmaceutical and biotech companies a profound (and sometimes painful) lesson: A business can only succeed if it has a digital infrastructure that supports the momentum of operations and processes when work must be performed remotely. In weathering the storm of a global crisis, pharma companies have learned how critical it has become to fortify existing infrastructures, ensure secure connectivity, and facilitate real-time collaboration among workers, partners, and vendors. The lack of robust remote access and virtual business process management and monitoring capabilities spelled doom for many pharma organizations over the past year.

Adapting to Volatile Times

In an industry that prizes innovation, the way we approach work must continually evolve — especially if we hope to respond effectively when challenges arise. Activities pharma professionals once believed could only be performed in person have been revolutionized by the proliferation of enhanced virtual capabilities, according to industry analysis firm LNS Research.

“Now with digital technologies, work on the frontlines is being revolutionized once again with deeper connectivity between the workforce and overall industrial operations,” LNS Research analysts reported. “Connected worker technologies enable greater integration between people and systems across operations, extending capabilities to wherever work is performed.”⁽¹⁾

Evolving work models are prompting pharma companies to revamp the way they manage their workforces. Gartner surveys show that 74% of companies intend to move some previously on-site workers to permanently remote positions.⁽²⁾ The research firm also projects that half of all factory work will be done remotely by 2024.⁽³⁾

To prepare for the challenges the industry is facing in the wake of the pandemic — and the countless unforeseen hardships yet to come — industry leaders are shoring up their existing digital infrastructures.

One example of the ways digital infrastructures are reshaping the industry can be found in recent changes to clinical trials. Protocols were adjusted in a variety of ways, such as allowing electronic patient signatures and virtual research visits, to make cancer clinical trials safe and easy to access when conducted remotely during the pandemic. Such activities are reliant on digital infrastructures and were so effective that they are expected to remain in place long after the threat of COVID-19 has subsided.⁽⁴⁾ Advanced digital capabilities are triggering similar changes on the regulatory side of the industry. And although regulators are unlikely to ever move to a 100% remote model for regulatory inspections, the European Medicines Agency (EMA) has already been performing virtual audits and the U.S. Food and Drug Administration (FDA) has started to apply a hybrid approach in certain instances.⁽⁵⁾

New virtual tactics will continue to extend as far as the technological capabilities allow. And with those advancements, new regulatory policies are sure to be established to accommodate the changes.

3 Steps to a Digitally Empowered Pharma Workforce

Preparing for pharma’s future entails ensuring that a company’s digital infrastructure is not only capable of handling the ever-increasing amount of remote work that will be performed, but that it can also provide stakeholders and auditors with digital access to all information and systems relevant to compliance processes. If your organization has not already done so, there are three critical measures you should take to get ready for whatever business and compliance challenges the future might bring.

#1 - Digitize Manual Processes

Paper is the greatest enemy of productivity and connectivity. Even so, many pharma manufacturers that consider themselves to be on the digital forefront still use paper documents in critical production activities, such as batch record releases and work instructions. Process digitization enables a company to efficiently distribute up-to-date documents and information directly to a worker who needs it for the job at hand, wherever they may be working. As emerging technologies like artificial intelligence (AI) are changing the pharma landscape, digitization is also proving to be an essential step toward integrating advanced tools that will soon become commonplace in the industry.

#2 - Implement Solutions That Connect People With Processes

The aim of any technology you implement must be focused on meeting the needs of your workers. Talent goes unrealized when organizations fail to connect employees with tools that elevate their work. Proven solutions that digitize processes involving document control, batch record releases, employee training, and other compliance-critical activities make employees more productive and allow them to devote more attention to core functions. They also give companies a significant advantage over competitors that still rely on manual processes.

#3 - Strengthen Remote Connections

Knowing your weaknesses is the first step to overcoming them. Internal IT teams or trusted partners can help you evaluate the security of your existing systems and determine the actions that are needed to strengthen connections. Deloitte’s industry experts recommend that pharma companies should identify and mitigate any system security risks that may exist and allow for remote access via virtual private network (VPN) when possible.⁽⁶⁾

To learn more about process digitization and integration and the other forces shaping the evolving world of pharmaceuticals, download MasterControl’s latest industry trend brief.

References:

1. “Connected Worker: Connecting People and Systems to Transform Frontline Operations,” Pete Bussey, LNS Research, Feb. 21, 2020.
2. “Gartner CFO Survey Reveals 74% Intend to Shift Some Employees to Remote Work Permanently,” Gartner press release, Apr. 3, 2020.
3. “Factory Innovation Post-COVID-19,” Gartner for Supply Chain, Gartner, Inc., 2020.
4. “Responding to Coronavirus, Cancer Researchers Reimagine Clinical Trials,” NCI staff, National Cancer Institute blog, June 29, 2020.
5. “Adjusting to the FDA’s New Hybrid Audit and Inspection Model,” Steve Lynn, GxP Lifeline, Dec. 3, 2020.
6. “COVID-19 response for Pharma companies: Respond. Recover. Thrive.” Deloitte, 2020.