As the uncertainty of COVID-19 continues, life sciences organizations must face the bleak reality that this is a new environment that they need to operate in for at least the next 12 months. The COVID-19 global pandemic has permanently changed how we work.
As we hear mixed messages from government officials about getting back to business as usual, companies must evolve and incorporate new ways of operating. One thing is sure, COVID-19 has forced companies to change how they do business to survive. External variables have changed dramatically, and internal systems and processes need to be transformed to address these new variables.
For most companies connecting in-person will continue to be a challenge, and for global companies, an even more significant problem. Travel continues to be restricted in the US and, although some European borders are opening, it is unclear what travel itself will entail. Picture wiping down airline seats and tables with Clorox wipes, lengthy immigration processes, extraordinarily long lines standing 6 feet apart, and other new requirements that make travel burdensome.
The workforce has transitioned to work from home, and many believe that this is not merely a temporary solution, but now a new way of working indefinitely. Paper-based processes that existed "under the IT radar" are becoming more evident and need urgent digital solutions. Old manual processes that relied on a "high-touch" approach and bureaucratic workflows are now forced to be nimble and digital. The situation demands it.
For instance, clinical trials need to be re-engineered. New patient enrollment was down 65% worldwide and 67% in the US in March. Individuals in high COVID-19 impacted areas are less willing to go into a physical site due to the risk of exposure. Deploying virtual visits and virtualizing study elements such as consent, randomization, and remote data capture could help. Technology, cloud-based solutions, and even simple tactical solutions like electronic signature applications can certainly help.
Accelerating your move to the cloud
With most of the workforce working from home, IT departments had to quickly provision new laptops and other IT equipment and ensure their VPNs were adequately secured. Further, they had to make sure they could handle the increased traffic and provide enough access for employees to do their jobs remotely. Traditional hardware-based VPNs require ordering equipment to upgrade, and some of that equipment has experienced shortage and out-of-stock challenges. Additionally, the increased remote access and security controls can impact performance, creating more IT challenges.
Companies that haven't moved to the cloud are now quickly accelerating their digital transformation IT roadmaps to move to the cloud and implement various SaaS-based applications to maintain business continuity. There are countless cloud vendor and SaaS applications to choose from, but not all vendors understand the requirements of regulated GxP environments. USDM has selected a community of vendors that understand the life sciences landscape
and the intricate nuances of GxP workflows to help you with your vendor selection process. Whether you are looking for a public cloud infrastructure solution from companies like Microsoft
, Google, or Amazon, or you are looking for business platforms or applications for critical business functions like Oracle
, or DocuSign
, USDM can help.
Another benefit of moving to the cloud is enabling faster collaboration, both internally and externally. The cloud allows for data sharing and interoperability within an organization's internal systems or among partners to improve collaboration. There has been increased collaboration in the life sciences to find a cure for COVID. One example is a collaboration between Takeda and their peers, coined COVIg-19 Plasma Alliance. They are developing a treatment based on the plasma of patients who have recovered from COVID-19. They are working on developing a drug made by purifying antibodies from donated plasma. This type of collaboration is critical to innovation, and faster innovation means a better chance to find a cure. Digital transformation is no longer a cliche buzzword. Compliance and regulations and the difficulty to change organizationally cannot be used as excuses anymore. Life science companies have to transform. This is a 'digital selection' age (akin to natural selection). Life science companies must evolve their business processes or perish.
Compliance and regulatory impediments are also breaking away. For example, the FDA is also endorsing a more modern approach to computer system validation with their upcoming new guidance - Computer Software Assurance
scheduled to release this September. This new guidance supports cloud technologies, automation, and enables life sciences companies to "take credit" for prior assurance activity and upstream and downstream risk controls like vendor qualifications. This translates to a significantly less burdensome documentation requirement in your validation processes and more focus on product quality and testing that can benefit from innovative cloud software testing practices. Why is this important? You can make meaningful changes to your business process with the best of breed cloud companies and accelerate your business process without exposing yourself to regulatory headaches or burdensome compliance overhead.
A simple tactical problem and solution: No more paper signatures
Life science companies are heavily reliant on GxP business processes that require records to be signed. Even today, in 2020, many of these are using handwritten wet signatures. Working from home makes getting signatures the old way, very time intensive and, in some cases, virtually impossible. In some cases, you may need to get numerous signatures in various countries and time zones. If it happens to be a GxP record, that record needs to be signed with an electronic signature that is Part 11 compliant
and archived in a controlled location. A tool like DocuSign plus its Part 11 add-on module
that has been validated can get you started. However, it is not as simple as rolling out a validated eSignature solution and releasing it to the company. Once available, users could take a GxP record and route for signature and forget about it. Once signatures are complete, it will arrive back in their email inbox. What is the percentage of time that they remember to move the electronically signed document to the right controlled location? How often will they create another document and route it for signature, forgetting about the first? What happens during an agency inspection if multiple versions are found?
This scenario highlights the need for a clear plan for which GxP documents will be routed for signature, how that will work, and how to get the signed document to the ultimate controlled repository every time. In the best case, there should be a technical solution that ensures form fields are pre-populated with accurate information; the right, approved signatories are selected and then seamlessly get uploaded to the right spot. Otherwise, an SOP should outline the manual process for regular reviews of DocuSign to ensure there are not any duplicates or unsigned or incomplete documents.
The key to a successful eSignature engagement is planning. Start by figuring out the GxP use cases that need signatures. As part of any eSignature effort, working with your teams to define the entire process is vital. Can some of the elements on the document be pre-populated by another system? Should the eSignature be automatically uploaded to the controlled repository? Get some preliminary time estimates of the AS-IS and TO-BE process to show the business value to automate the effort potentially. Rank and prioritize the opportunities to automate parts of the process. Often, starting with some quick and easy GxP documents provides the project team with some wins to get some early success. Then, move on to the more complex use cases that require automation and customization that take more effort and time to complete.
Another important factor is user adoption through an organizational change management program. What kind of communication is being circulated to gain awareness about the initiative? It is critical to share important details about why the change is happening and what is in it for them (time saved is a big one). Make sure you communicate the training plan. Do you have SOPs by a business process that outlines which controlled repository to save the GxP record? Have you spent the time to address potential resistances to the initiative (e.g., regulatory impediments, compliance impediments, and resistance to change existing process)?
COVID has fundamentally changed how life science companies operate. With a mostly remote workforce, paper-based processes, and cumbersome, manual workflows must be eliminated. There is a high degree of pressure on life science CIOs and CISOs to build secure cloud-based systems with nimble workflows across various business units, partners, etc. GxP systems and business processes have to go CLOUD to survive. One thing is clear; there will be no quick fix to the COVID-19 global pandemic. The silver lining in all this - if planned correctly - we can use the cloud to help increase our productivity during these times and, after all of this is behind us, we will have eliminated wasteful processes and bureaucracy and achieved more streamlined operations and a more balanced work-life.
to discuss your vendor options and gain insight into what vendors have GxP-ready solutions, with continuous cloud compliance built-in to manage ongoing updates.
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About the Author
is Head of People and Co-Founder of USDM Life Sciences. Vega focuses on recruiting the best people, developing USDM's talent, and cultivating the company culture where everyone is connected, inspired, and empowered to make an impact on our customers' sites. Vega's commitment to innovation in business and people has helped curate the best and brightest talent in the life sciences industry for USDM and our customers. She has been supporting life sciences companies building powerful teams for 20 years. She holds a BA in Political Science with International Relations emphasis and French Literature from the University of California, Santa Barbara, and an MBA from the University of Southern California.