It's a common scenario if you're a biotech or pharma manufacturer. Your people feel the constraints of the first accounting software package and the other systems and spreadsheets implemented in the early days of operations. The days when ambition and possibility were considerable, but your systems budget was small and so “good enough” kept the business going from an operational standpoint.
Then growth hits. Maybe your business is acquired, or perhaps your organization is the one doing the acquiring. As a result, you face challenges like normalizing quality management across multiple departments or addressing specific data security issues. Maybe you simply feel restricted by the business applications you initially selected. At some point, every CEO or CFO admits, "we need something else."
As a quality leader, do you know what’s on your “must-have” list when it comes to selecting a new business application? Or better yet, what’s on that vision board? Are you exploring what’s possible in the day of cloud technology and digital platforms? The right digital platform can be the catalyst you need to drive new, better ways of doing what you do while still ensuring you meet all compliance and regulatory obligations.
When we meet with biotech and pharma quality leaders, several topics are top of mind. These discussions typically center around immediate pains and needs, which are critical to keep the business moving forward. However, we also take care to ensure we lay the groundwork for how the decisions they make today will set them up for future success. And that starts with the right digital platform — one that improves today’s processes but enables powerful future scenarios.
This article will address a few of the topics we explore with quality leaders to determine how they can achieve greater performance while maintaining high-quality production with the right operational capabilities built on the right digital platform — with actions, access, and audits in the forefront.
Extending quality beyond your four walls
Today, the lines between business models are blurring, allowing digital connections to extend out to patients and providers and move upstream to vendors and manufacturers. For example, you may have electronic monitoring devices traveling with your product through the steps of the supply chain, monitoring temperature, number and degree of impacts, and timing. Or, you may capture patient-specific data through portals or mobile applications (yours and others that you partner with) and have it returned to you.
As these processes advance outside your four walls, your operating procedures and the rigor with which you operate do not lessen. As workstreams get more interconnected and cover a more comprehensive range of processes, materials controls, quality controls, and quality assurance must expand with them. These scenarios may occur across various business applications and devices, often resulting in synchronous processes that have different levels of quality and control rigor. And they need to happen in a compliant way, which means you need to have a platform that will support your regulatory compliance and quality.
Quality leaders must maintain control of the data that results from these expanded processes and user experiences. You need the ability to design, configure and enforce workloads and procedures according to security levels or roles. You need to securely establish who can, who can’t, when they can, and when they can’t, and ensure every step is captured with an audit trail.
With all the additional controls this new era of quality presents, you might be wondering what impact it will have on your ability to meet delivery dates. What our customers are finding is that the right digital platform can help shrink cycle time related to quality testing while doing it better at the same time. When it comes to this type of security and data control, look for modern digital platforms with built-in services to run against the data, discerning patterns and providing alerts.
Incremental validation and verification in the cloud
As recent as five years ago, biotech and pharmaceutical companies were apprehensive about operating FDA-validated business applications in the cloud. The idea of moving critical business applications from in-house servers and seemingly beyond their control was daunting and raised many questions. But now, the tide has turned, and life science manufacturers are embracing cloud computing, viewing it as not only a smart move but a necessary one.
In this cloud-first era, FDA-regulated organizations still must ensure that their solution operates within a “closed” cloud data architecture, which means it has the data integrity and preventive controls to meet regulatory compliance (21 CFR Part 11, 21 CFR Part 820, and EU GMP Annex 11). This includes change control for data and configurations that support significant processes.
In the old days, a closed system meant running your validated business applications on in-house servers and “closing” those servers off to be able to prove that the data could not have been tampered with or deprecated. Now that all modern business applications run in a cloud server environment, you are still responsible for ensuring the integrity of your data. To do so, you need to make sure that the cloud environment running your validated system is SOC 1 Type 2 and SOC 2 Type 2 audited and is certified according to ISO/IEC 27001 and ISO/IEC 27018 standards. This gives you the defensible position you need with the FDA to prove that your validated system runs in a “closed” system environment.
The right cloud platform also enables clear, delineated environments for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), along with Production, all with change controls. Ensure you can establish these multiple environments, using well-perform- ing and tracked change controls, in the cloud environment you choose for your validated systems.
The cloud platform should also enable your validated system to operate with all required capabilities to maintain GxP compliance. For example, independent validation and verification (IV&V), in accordance with FDA guidelines, provides documented evidence that a system per- forms according to its intended use. Finally, the platform can be enabled for initial and sustained re-validation in an iteratively updated cloud environment.
Your business applications provider should be able to help guide you through this pro- cess to ensure the selected IV&V partner will provide the level of quality required to meet any future FDA inquiries or audits.
Interoperability via the cloud
Every patient population now has some mobile or web-based application that helps them. Common scenarios include individuals with Type 1 and Type 2 diabetes who use glucose monitors and insulin pumps connected to mobile apps that inform and guide their actions. But next- generation business models are blurring the lines between the product and the delivery device, and dosage is evolving from clinical settings to self-administration. To make your product and therapy part of this digital ecosystem and patient experience, yours must interoperate with these other relevant applications.
Interoperability also comes into play whenever discussions arise around how to improve supply chain efficiency. These scenarios may center around procurement and material control outside your four walls or internally across departments. If you’re not thinking about ways to connect with others on the value chain – whether it be data exchange with a device that helps improve your therapy or direct-to-patient and provider interactions – you can be sure your competitors are.
The right digital platform will allow you to securely share data in a meaningful way with device partners, delivery partners, third-party mobile apps, and labs while enforcing data compliance and control.
Data as the foundation
In the past, biotech and pharma executives looked at their business applications as the ultimate foundation of their information strategy. The prevailing thinking was, “how do I get all of my data into one or several common business apps that are secure and enable all the workloads I think I’ll need to execute our strategies?” However, increasingly, innovative biotech and pharma business leaders are looking at their digital strategy in the context of “digital disruption” and seeing their data as the foundational component.
The shift to cloud computing has unleashed services that enable new digital strategies. However, as an FDA-regulated biotech or pharma company, care must be taken to ensure that any of these scenarios operate with GxP and possibly PHI compliance where required.
For example, suppose you extend delivery and handling of your drugs into an app that tracks devices inside the package (think COVID-19 or Influenza vaccines) with a mobile component and portals to handle delivery, excursion management of dam- aged lots, and acceptance by the verified recipient. In that case, those transactions have to capture the associated Part 11 audit trail data (such as before data value, after data value, timestamp, who changed it, etc.) and reassemble the audit history for an FDA audit. Some of those actions may require dual signature authorization.
Dominant cloud providers like Microsoft and Amazon have taken steps to expose the data of their business apps into an underlying overall data model that is accessible to these available cloud services. This access enables quality leaders to explore new opportunities, from extending workloads to mobile devices and web apps to running AI algorithms against critical vendor data combined with outside data to predict delivery performance.
When you choose your optimization-driven, cloud-first platform, you want to do that with your eye on the future. You want to be sure you have your data in the right place to “light up” all the services that come with the platform. An innovative digital strategy pays attention to digital and operating compliance while executing these strategies to emerge on the winning side of change.
Summary
The tremendous potential of biopharma requires organizations to be ready for significant growth at a moment’s notice. The platform and business applications partner you select should support your ambitions as you prepare for future challenges.
One thing is shared across the most successful businesses: they view their business application selection as a digital platform choice. They understand that the cloud platform on which the data resides will make a significant difference in their ability to improve operations today and to channel their organization through the sea change they face in the future. In addition, they engage the time and expertise required to properly define their current processes and explore their ideal business flows before selecting the digital platform that will best enable them.
Whether you’re in pharma or biotech, your business is continuously forwarding the frontiers of knowledge in life sciences. It is the job of any consultant or system integrator you partner with to equip you with the digital tools that will help you achieve your goals more swiftly and methodically. Ensure the discussions you have address operations today and point you on a forward trajectory toward amazing possibility.
There has never been a better time to help navigate your organization through this digital transformation so you can do what you do even better.
