Updated on September 27, 2019 by Rick Emlet
Everyone knows that in a short amount of time, the cloud has changed the way we do business – for the better and for all time. We’ve entered into a bold new era where communication and collaboration are easier than ever. It’s now possible to be just as productive at home (or halfway across the globe on vacation) as you can be in the comfort of your office.
But what a lot of people don’t realize is that the cloud also has fascinating implications that vary depending on exactly which industry you’re talking about. Case in point: life sciences organizations rely on modern technology to create medical equipment, drugs and other essential items all in the name of empowering society. If you are someone related with these regulated industries, then you likely have come across the term GxP, which is the acronym for Good (Anything) Practice. This ‘anything’ can refer to any of the following descriptors- it can be manufacturing, clinical, laboratory, or clinical laboratory, signifying that these are efficaciously meeting the pre-defined guidelines and are safe to be used for the intended purpose. Because the stakes are so high, GxP compliance is a paramount concern which drives nearly all life sciences manufacturing processes from consistent batch recipes to quality computer systems.
But cloud validation doesn’t just enable regulatory compliance for those who have dedicated their lives to the life sciences industry. Instead, it offers many additional benefits and opportunities that are worth exploring.
What is Cloud Validation?
As the name suggests, cloud validation refers to the process of checking to make sure that a particular software or computer-based system actually meets the specifications required and fulfills its stated, intended purpose. In other words, it’s a way to ensure that an infrastructure performs as designed and intended… repeatedly producing the results which satisfy your requirements.
A validated environment is one where evidence has been documented demonstrating that a procedure, a process or an activity maintains the desired level of compliance at ALL stages, period.
Cloud Validation and the Life Sciences Industry: The Perfect Pairing
All of this is very important to consider with respect to the life sciences industry, particularly those organizations that are working in fields like biotechnology, pharmaceuticals, cosmeceuticals, food processing, and related matters.
These types of businesses are subject to FDA GxP regulations and, as a result, have historically been very conservative when it comes to adopting new types of technology. If your infrastructure isn’t GxP compliant, your product(s) and company are at risk of severe consequences ranging from having products pulled from the market to monetary penalties or worse.
Learn more about the How CMOs Can Leverage the Cloud & Pass Benefits onto Customers.
Because of this, the validation of any environment is always equal parts time-consuming and expensive. But thanks to the cloud, this story plays out in an entirely different matter. The types of validation procedures that normally occur during the Installation Qualification (otherwise known as the IQ) or Operation Qualification (otherwise known as the OQ) are more often than not provided by the software vendor and/or the Infrastructure as a Service (IaaS) providor- allowing life sciences organizations to defer to and rely on the expertise of their IT partners and focus on their core competencies.
Some cloud-based providers, like Outer Edge Technology, often have sophisticated tools built right into their platforms, allowing them to seamlessly partner with their customers to provide the evidence necessary to demonstrate IQ GxP compliance.
But even going beyond the matter of maintaining compliance itself, cloud validation (and to a larger extent, the cloud) help life sciences organizations in many other ways. By providing an easier path to qualifying a cloud infrastructure, it’s also easier for those businesses to take advantage of emerging capabilities and tools. The process of meeting and maintaining a continuous level of quality over the long-term is facilitated by today’s advanced technologies.
Not only does this help create a GxP compliant IT environment where innovation is achieved much faster, it does so at a time when these life sciences organizations are also increasing efficiency AND reducing costs simultaneously.
All of this is possible due to the security, integrity and the high-availability of the data stored in the cloud. These are advantages that would have been unthinkable to most life sciences organizations even as recently as a decade ago but now, thanks to the cloud, they’re a necessary part of day-to-day business.
Related article: Cybersecurity Needs to be a Priority for Life Sciences Companies.
Outer Edge Technology: Your Partner in the Cloud, Your Partner in the Future
At Outer Edge Technology, we’ve long believed in the power and advantages that cloud computing offers. The ways in which cloud validation simplifies compliance for the life sciences industry may be specific, but their larger implications couldn’t be more clear. It is a shining example of what the cloud can do when leveraged properly.
At its best, the cloud allows us to get out of our own way – putting technology to work for US again instead of always feeling like we’re working to keep up. At that point, companies are able to devote more time, care and attention on their core competencies – which is ultimately the most important benefit of all.
If you’d like to find out more about how cloud validation fits in to your GxP operations, or if you’d just like to discuss your IT options and requirements in more detail, please don’t delay – call 1-844-OET-EDGE or email info@OuterEdge.biz to schedule an appointment to speak with one of our technical experts.
