How Secure Is the Cloud for Pharma Manufacturers?

16 out of the top 20 pharma companies leverage cloud technology to accelerate drug production. And as of 2022, 57% of businesses are moving operations to cloud-based software solutions.

But what’s the reason behind this mass cloud migration? And more importantly, can the cloud really deliver on its promise to safely streamline operations?

In this article, we’ll explore how the cloud works and how secure it is for pharma companies.

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SaaS for Pharma: An Overview

What is SaaS?

Software as a service, also known as SaaS, is defined as “a way of delivering applications over the internet as a service.” As opposed to purchasing servers and installing software ad hoc, and needing to maintain and update it, SaaS allows users to access the systems they need via any device with an internet connection.

Examples of SaaS include Gmail, Netflix, Salesforce, and Slack. As opposed to “owning” the software, it’s available to users on a subscription basis (typically, monthly or annually). The cost includes access to the software, support, and rolling updates.

Not only does this save money, as purchasing software and systems outright is expensive, it also offers users benefits including greater speed and accessibility.

How is SaaS used in pharma?

SaaS is used in the pharmaceutical industry to optimize drug development and manufacturing. Digital, SaaS-based solutions such as manufacturing execution systems and laboratory execution systems allow pharma professionals to collaborate more effectively across sites and teams, capture and transcribe processes in real time, and accelerate the entire production lifecycle.

Currently, SaaS is used most frequently for front-end operations in pharma, such as CRM and clinical trial management. While it’s especially well-adopted in this area, it is picking up traction in back-end operations as well, such as manufacturing and quality control.

Cloud vs On-Prem Software

Setting aside specific use cases and capabilities, the primary differences between cloud and on-premise software relate to the ownership, location, and upkeep of the systems.

What is cloud software?

Cloud-based Saas solutions are hosted online, meaning the associated data is available from anywhere, anytime — as long as there’s an internet connection.

On the cloud, users can access these solutions via a licensing agreement that provides them with instant access to the solution once it’s activated. Additionally, the software updates, maintenance, and support are handled through the licensing company.

Take Netflix, for example. Once you set up your account, you can log in from anywhere and start streaming movies. You don’t need specialized equipment or anything in-house (aside from a connection to the internet).

What is on-prem software?

In contrast to cloud software, on-premise software lives onsite and requires specialized hardware, installation, and training before it can be utilized.

The upfront capital investment is a lot higher than cloud-based SaaS solutions because of these factors. Additionally, maintenance fees and support are not typically covered. As such, any issues that arise often result in additional costs.

For on-prem solutions, all aspects of the setup from the initial deployment to the ongoing maintenance are handled in-house. Companies that leverage on-prem solutions have full control over their systems, including who has access to what — and when. These solutions operate independently of external factors, meaning they don’t rely on an internet connection to run, and are instead accessed via specific company devices.

Although accessibility is limited because the data is only accessible via select company devices, companies do maintain full control over their on-prem systems. Additionally, when onsite, these systems can be used without a connection to the internet because they aren’t cloud-based.

Hybrid vs Public Cloud: What’s the Difference?

Whether it’s a video streaming service, data storage provider, or SaaS solution designed to streamline operations and reduce costs — hybrid cloud and public cloud solutions both aim to serve a similar purpose: to make life easier.

But there are also key differences between the two, especially as they relate to data accessibility and usability. In this section, we’ll review the top differences between hybrid and public cloud solutions.

What does hybrid cloud mean?

The hybrid cloud combines privately stored data with the public cloud. This approach enables companies to get the best of both worlds — they can share data, on demand, between sites and teams while still maintaining their in-house solutions.

In this way, hybrid cloud software provides a workaround to lifting and shifting an entire system in a full cloud migration.

What does public cloud mean?

As the name suggests, the public cloud provides users with access to various resources and software solutions via the public internet.

The costs of public cloud software range from free to subscription or usage based. There are no hardware requirements (except for having access to a device with an internet connection), and the software can be implemented immediately once the subscription begins.

How Secure Is the Cloud for Pharma?

So, how secure is the cloud for pharmaceutical manufacturing? To answer this question, we’ll consider three key elements of cloud security: access, compliance, and motivation.

In other words, how easy pharmaceutical cloud software is to breach, how well it can maintain compliance with evolving FDA regulations, and the reasons behind these security risks.

Cloud security consideration #1: Access

Let’s start with access levels. The connection between cloud servers and a user’s browser is encrypted, which means the flow of data between the two is scrambled and coded to prevent unauthorized access. These servers are also monitored continuously to protect the cloud from cyber attacks and security breaches.

However, this process isn’t absolute. Security breaches do happen from time to time, which is why it’s important to stay aware of potential threats and vulnerabilities.

Arun Tomar, Apprentice’s Director of Engineering – Cloud Infrastructure, considers cloud access risks from these two angles:

1. Physical access: To achieve physical security, cloud vendors must implement best security practices and update them on an ongoing basis. Those could be verified by the certification and audits published by the cloud vendor.
2. Application access: Just like any other public software, pharmaceutical software is prone to attack. It's the vendor’s responsibility to design, code, and deploy related infrastructure and application code to withstand these attacks.

As with any software, breaches can occur. However, it’s important to note that the vast majority of cloud security issues are directly related to how sensitive information is set up and managed internally.

According to a recent McKinsey report, “Almost all breaches in the cloud stem from misconfiguration, rather than from attacks that compromise the underlying cloud infrastructure.”

In fact, Gartner predicts that through 2025, “99% of cloud security failures will be the customer’s fault.” In other words, the onus of achieving and maintaining cloud security is on us, not cloud technology itself.

To minimize risk of internal cloud security issues, pharmaceutical companies can:

• Educate their teams about cloud usage and best practices
• Enforce mandatory policies such as password strength and length
• Leverage password managers to auto-generate complex passwords
• Proactively address potential gaps in organizational knowledge or adoption
• Implement cloud governance to ensure cloud policies are properly maintained

Cloud security consideration #2: Compliance

Next, let’s consider an especially vital security concern for pharmaceutical manufacturers: regulatory compliance.

For highly regulated industries like pharma, cloud SaaS solutions take security a step further. These systems are designed to maintain stringent compliance, security, and privacy standards to protect sensitive data and processes. Protecting data is of the utmost importance for these companies, and SaaS solutions that are truly created for pharma abide by security and compliance standards such as GDPR, ISO 27001, cGXO, and 21 CFR Part 11.

In fact, the cloud not only accommodates FDA compliance, it facilitates it. Because cloud service providers update their software on an ongoing basis, cloud providers are able to stay up to date on evolving regulatory requirements and Good Manufacturing Practices (GMP).

For example, in September of 2022 the FDA released new draft guidance on software validation. Savvy pharmaceutical solution providers are already meeting these new guidelines by anticipating and adapting to evolving regulatory requirements such as these.

“Security is not a one-time activity. It’s a continuous process. This is especially true in the pharmaceutical space, due to its nature of evolving regulatory guidance and privacy standards.”

— Arun Tomar, Director of Engineering – Cloud Infrastructure, Apprentice

Cloud security consideration #3: Motivation

Last, let’s consider why these attacks are even occurring in the first place.

Like so many things, it all comes down to capital. Money is a core motivator for security breaches. But knowing is half the battle — an awareness of this incentive can help to ward off all but the most dedicated hackers.

To make your software less appealing to would-be attackers, make it harder — and therefore more costly — to compromise.

“At the end of the day, attackers are mostly trying to make a few quick bucks. So, if we make our systems more time- and resource-consuming, and therefore more expensive for attackers to penetrate, this could serve as a deterrence.” 

— Arun Tomar, Director of Engineering – Cloud Infrastructure, Apprentice

A holistic approach to cloud security

So, is the cloud safe? When deployed correctly, absolutely. Cloud vendors invest heavily in security, hiring the sharpest minds in the business and using the latest advanced tools to ward off threats.

But 100% protection can’t be guaranteed by any software, cloud or otherwise — which is why you must be discerning about your software’s permissions, maintenance, and vulnerabilities.

“Your system is like a castle. As software providers, we are in charge of building and defending it. And the attacker is constantly testing your system for weaknesses to break in and compromise your system. That’s why you need to invest in a trusted vendor — after all, who lets a castle go unguarded?”

— Arun Tomar, Director of Engineering – Cloud Infrastructure, Apprentice

Think of cloud security the way you think of driving — is driving safe? Yes, but only if the person behind the wheel is licensed and lucid. In the same vein, cloud software is secure when it’s from a vendor you can trust.

To achieve cloud security, organizations should be proactive about educating their teams, implementing best practices, and ensuring that they’re understood and adopted by all.

Closing Thoughts: Cloud-Based SaaS for Pharma is a Win-Win-Win

Cloud-based software, especially when it’s built specifically for pharma organizations, is a win-win-win scenario for pharma companies.

Not only does it provide organizations with a secure place to store sensitive information, it also offers real-time visibility into the entire drug production lifecycle. This means you have all of the access you need — at your fingertips — to initiate a tech transfer, collaborate across sites and teams, respond to changing market conditions, and accelerate drug development and manufacturing.

And best of all, cloud software provides the means for instantaneous communication — the missing piece of the puzzle for true cross-functional collaboration.

In this post-COVID world, distributed teams are now the norm. That’s why it’s never been more crucial to eliminate communication barriers between teams. Fortunately, that’s exactly what cloud software is able to provide.

Through instantaneous updates and real-time data transfer, cloud technology can close the gap between disconnected teams. This is especially critical in the pharmaceutical space, where communication silos and data transfer delays can often spring up between sites, teams, and drug development stages.

By adopting cloud technology, pharmaceutical organizations can harness the power of real-time data visibility to keep everyone on the same page, and share crucial information when it’s needed most. Which means staying on track, under budget, and ahead of the curve.

We aren’t gambling people, but if we were, we’d bet on the cloud.

Ready to increase your odds of winning? Get in touch with our team to learn about our Tempo Manufacturing Execution System. Its cloud-based system built exclusively for — you guessed it, pharma! — to enable continuous production, automation, and customization.

Our Featured Thought Leader

Meet Arun, Our Cloud Guru

• Who: Arun Tomar
• What: Director of Engineering – Cloud Infrastructure
• When: 1.5 years at Apprentice
• Where: Canada
• Why: Arun’s passion for cloud engineering is contagious, and his insights on cloud security best practices are top-notch

Arun’s background

Arun Tomar is a cloud engineering professional with over 15 years of experience. He loves problem solving using technology and believes in continuous learning.

Arun has helped a lot of startups to large enterprises with digital transformation, cloud adoption, migration, automation and security. He’s an open source evangelist, but strongly believes in using the right tool and technology for the job, even if it’s proprietary.

Cloud security: Arun’s point of view

"Security is all about trust. Trust between computers, networks, vendors, and clients.

There are different layers in the software system, all the way from physical to application. Make sure to consider each of these layers in your cloud security strategy.

And remember — there is no such thing as a perfectly safe system. Every running and accessible system is vulnerable. Given enough time, resources, and expertise it might be possible to compromise any system. All we can do is to make it more expensive, and therefore less worthwhile, to attack our system."

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