Last Updated: 7th September, 2020
Data Integrity and Cloud Security: Organizations in the life sciences, space often generate loads of data-that much is self-evident, but how to accumulate it may not be so straightforward for the organizations themselves. As more and more organizations are shifting from on-premise to cloud-based storage systems (and will enjoy a competitive advantage of doing so), some may hesitate, fearing an inability to interpret or comply with regulations, or perhaps that their data will not be secure.
We may argue that the resistance companies may feel, while, understandably, is largely unfounded – and that moving to the cloud actually has many advantages, as it generally meets and exceeds regulatory requirements for data integrity and cloud security, along with ease of access. In this time of Covid19, these benefits have become all the more evident.
A common concern, we hear from organizations is the idea of the cloud in general, since it conjures up visions of a diffuse, non-localized storage system, which may seem at first glance less secure than a computer terminal in one’s own facility. This is not the way it works, of course – the storage is in reality highly configurable, controlled, and relocatable.
In fact, a company can actually lock down the geopolitical region, country, or state in which the data will reside, and since regulations are underpinned by governing laws of that region, understanding them is essential. However, precisely for safety reasons, the street address for high-security, cloud data centers is often not disclosed.
Many large Infrastructure as a Service (IaaS) organization, such as Amazon Web Services (AWS), have made the decision not to provide the exact street address for their data centers to reduce cloud security risks, which has now become best practice. When data is stored across multiple, highly confidential locations, the data is actually more secure and less likely to be subject to data integrity issues.
Since being able to “see” the data remain a regulatory requirement, the cloud indeed makes it much easier to do so, as it allows for access from multiple computer terminals and systems. The challenge for life sciences organizations is being able to demonstrate to auditors that suitable due diligence of the infrastructure has been carried out without being able to visit the location, or perhaps scarcely identifying the exact location the data is stored.
Interpreting the regulations that govern data storage is clearly essential, but can be challenging, as some are open-ended or haven’t kept pace with technology. For instance, the UK’s Organization for Economic Co-operation and Development regulations states: “The location(s) where the study plan, samples of test and reference items, specimens, raw data and the finished report are to be stored.”
However, there is no definition of “location.” Once upon a time it would have meant a lab book or a specific computer terminal, but in the contemporary world, it could mean the facility site name, geographical area, URL, cloud databases, and so on. This wording can make use of the most recent technology challenging, but not impossible. The Food and Drug Administration (FDA) draft GCP guidance goes further than others in allowing SaaS applications (Software as a service) for clinical investigations, provided certain conditions are met.
A potential solution for showing that due diligence checks have been carried out is to rely on the compliance documentation of the supplier. While certifications such as ISO 9001 and ISO 27001 do provide assurance, there is a limited transparency: A successfully audited pharmaceutical organization may not be efficient to provide full details of the audit, leaving the organization feeling unsure it can demonstrate that risk has been sufficiently mitigated.
Justifying SOC 2 is a much more transparent and user-friendly system, as it lists out all the controls and any known exceptions to any of them. For a SaaS organization to describe, they are compliant with SOC 2, they must show not only that they have the relevant controls in place, but that the controls have been operating effectively over six to 12 months. This type of prolonged, multi-point audit provides a level of visibility and insight that’s immeasurably superior to a one or two-day audit on-site.
Veiga and Calnan (2018) offer a subtle example of a pharma company outsourcing its R&D to several sites of a clinical research organization (CRO), who in turn outsource the data collection duties to a hospital who collected the trial’s participant data. The CRO also contracted a third-party IT company (SaaS Provider) for data management. The example demonstrates that the data integrity of the data can be maintained in highly regulated situations, while satisfying regulatory requirements and nevertheless maintaining the best practice attributes of cloud security.
Covid-19 has been a wake-up call for some organizations, who have been forced to grapple with their past hesitance in shifting over. It’s also highlighted the satisfactory position of organizations who have already transferred to a cloud-based system, fully capable of work from home during the lockdown. They have also been successful in preventing the complex decision of deploying employees and inhibiting them at risk or holding them out of risk, consequently reducing support or levels of service.
If you consider the cloud security and flexibility (as well as benefits not discussed here, including cost-savings and the ability to integrate with innovative technologies), it’s intricate to argue against migrating to the cloud.
Customers who perform the analysis and comprehend the regulatory requirements to maintain the competitive advantage of a market pressure point of view, of whom customers who do not do so will lose, therefore. The market is going into the cloud-the question is how fast and who will be left behind.