The life sciences industry is no stranger to cloud computing. However, due to the risk-averse nature of our industry, especially in quality assurance, cloud solutions haven’t always been a primary consideration for leading life science organizations.
With the recent pressure by western governments to deliver better and cheaper drugs to the public, cloud-based solutions have been progressing at a much faster pace.
As with any regulated industry, it’s usually the big fish that tends to first adopt new technology. This is mostly due to their ability to invest in expensive systems where others can’t, but also due to their ability to benefit on a much larger scale.
As we continue to move through the ‘information era’ where previous concerns about cloud computing have become old myths, and cloud-based solutions have become increasingly affordable, the business case for small to medium life science organizations moving to the cloud becomes even stronger.
This article will outline 7 arguments supporting why smaller organizations should move their quality management system (QMS) to the cloud.
Since the early days of business operations technologies, cost has always been the primary factor preventing small organizations to benefit from the latest and greatest QMS. With the proliferation of cloud-based technology, this is no longer the case.
Top of the line systems can be made available without investing in costly infrastructure, hardware and software that depreciate faster than the money you are hoping to make or to save from them. For many small organizations, the total operating cost of a cloud-based solution does not even come close to having IT staff on payroll.
In fact, the investment required to deploy a QMS on premise for a small user base would support operating a cloud-based quality environment for years (not including loss of opportunity costs and the operational disruptions deploying large technological products can often represent).
Small businesses rarely wish to remain small. When demand grows, a critical success factor for new biotech’s and small device manufacturers trying to make it big is the ability to grow headcount, without negatively impacting the quality of products and services.
Having an intuitive quality system enabling process standardization is a great way to eliminate costly newbie mistakes while shortening the learning curves for new hires. Or, maybe you need to hire an expert in some remote part of the world? Not a problem either. Your quality system is now on the cloud and accessible from anywhere, at any time. This means growing your business how and where you want or need, without fear of paying a hefty quality price.
With cloud-based quality, you can have a geographically dispersed team AND a centralized QA unit. It’s the business operations equivalent of having your cake and eating it too!
Small businesses are more vulnerable to market swings. When demand goes up, it is imperative not to lose opportunities due to the inability of a system to scale up fast enough. Growing is great, but sadly, it is also sometimes necessary to cut back to adjust to the market reality. The ability to quickly scale up or down a system based on needs is known as elasticity.
When times become hard, nothing is more frustrating and burdensome than having to pay for what you no longer need. Cutting down on system costs (you know, all those powerful servers working at 25% capacity) could allow you to keep a few more people employed, people you never intended to let go, people that will make a big difference into getting you back on the upswing.
As the world has gone flatter, we have seen the jack-of-all-trades and master-of-none businesses vaporize. Competition, which is fiercer than ever, is now occurring at a global level. In this reality, focusing on core competencies is key to business success, if not to business survival. With this in mind, it becomes increasingly difficult to justify spending a large portion of your hard earned revenue and your scarce capacity into deploying and maintaining electronic systems.
Cloud-based quality is an opportunity to help you focus on what makes, or will soon make, your organization successful. If you are often feeling like quality is a necessary evil tied with operating in a GxP world, you could soon realize that it can easily become a competitive advantage fostering employee empowerment, continuous improvement, cooperation, and profitability.
If there is one hot topic in the industry worth mentioning in relation to cloud-based quality, it is the subject of compliance. Without an electronic quality management system, it is very difficult and time-consuming to ensure your procedures are being followed.
If you’ve ever reconciled your training requirements with your training records, you will know what kind of headache I am talking about. A great advantage for small businesses moving quality into the cloud at the present time is to benefit from systems that were designed with regulation and efficiency in mind. Such systems also support your ability to become and remain regulatory compliant, while making it that much easier to prove it to potential clients or regulatory agencies.
Is your quality unit forced to play “quality police” instead of focusing on quality assurance? “I am really sorry, Bob, but you used the wrong template to create this new SOP. You will need to transfer its content into this format instead.” This real-life scenario doesn’t make anyone happy and it doesn’t happen with a proper cloud-based quality system.
Such a system will bring a level of standardization to your operations that will save valuable time, with the added benefit of ensuring that your established processes are being followed without being a source of demoralizing internal conflicts. Fewer mistakes, less rework and less paper for everyone! If you’re striving to become a LEAN organization, and you’re still operating a paper-based quality unit, now might be the time to re-evaluate. There is a much better way, and it is easier to switch than you think.
In small organizations, it is often necessary to navigate based on intuition, rather than on data. The main reasons for this are simple: data is not always readily or easily available, reports are time-consuming to produce and decisions must be taken rather quickly. It doesn’t have to be that way.
By taking quality on the cloud, information is captured in real-time and can be tracked and trended instantaneously. Every system list, every quality incident, every procedure, can be quickly and easily be leveraged, now or in the future. This is the kind of insight that allows quality to switch from a reactive mode to a proactive one.
All this information also supports your management in meeting its oversight responsibilities, without requiring a small army of people producing time-consuming ad-hoc reports on a periodic basis.
In conclusion, cloud computing has become a very attractive option for small organizations to sharpen their competitive edge. Even with a small user base, you can now benefit from the economy of scale previously reserved to large corporations.
With the ability to bring your quality on the cloud made so easy, the old barriers no longer stand but the benefits are still very tangible and meaningful. For small organizations where focus, growth, efficiency and compliance are an integral part of true success, bringing quality on the cloud is no longer a luxury. It is becoming more and more a necessity.