Times are changing. Increasing competition, regulatory scrutiny and tightening margins are a few of the challenges facing Life Sciences Companies. As a result, drug and device manufacturers are evaluating every aspect of their operations to identify opportunities for greater efficiency and productivity.
If your company is among those that rely on paper or point solutions, here are three reasons to consider an integrated quality management software system.
In this second part, we continue our interview with Bruce Kratz and Jon Ragati, homing in on FDA requirements, making the transition to cloud QMS, and the long-term outlook.
While many of our readers already leverage quality management system (QMS) software, there are many manufacturers today who struggle with paper-based or manual systems to track, manage and report on quality events. And while some may use email, spreadsheets, or homegrown software systems to “digitally” capture quality events, gathering and consolidating information for audits and reporting can be a challenge.
Even for those with established QMS solutions, they may be looking to cloud-based solutions to extend their quality and compliance initiatives without increasing their IT infrastructure footprint or IT spend.
Luckily, there are now several cloud-based quality management solutions that offer many of the advantages of an on-premise solution while minimizing IT demands. Although cloud solutions have been used in other parts of the enterprise for years, cloud computing is playing an important role in IT enabling Quality, according to the analyst firm, Gartner. The core benefits are:
- Collaboration: Work across and beyond your organization in a shared environment, from anywhere in the world, at any time.
- Flexibility: Quickly scale your solution to meet increased business demands and quality needs, without having to make capital expenditures.
- Security: Cloud providers have many security layers that can avert data breaches. In fact, many have argued that your data is safer in the cloud than it is in your own office.
So how can you get started down the right path with the right cloud-based quality management solution?
Step 1: Make sure you’re not simply digitizing handwritten logs. Many cloud QMS solutions offer out-of-the-box workflows that are based on industry leading best-practices. By implementing those best-practices, you can accelerate your deployment and avoid the pain of learning by trial and error.
Step 2: Choose a proven solution provider that is purely focused on quality management systems and can serve as an advisor. Many newer solution providers thrill prospective clients with sleek user interfaces and fancy visualizations. But they often lack the expertise to overcome common roadblocks. Thus, implementations fail, resources are wasted, and quality initiatives collapse.
Step 3: Leverage data analytics to track progress and prove ROI to your management team. Many cloud QMS solutions can help you to intuitively piece together data from different sources and different stages in a product’s life cycle. This increased visibility reduces the risk of falling out of compliance or having to pull a product from the market.
To learn more about cloud QMS and how you can accelerate or extend your quality management strategies, download the eBook, “3 Steps to Quality in the Cloud”.
From SMBs to global enterprises, life sciences companies have learned to accept a certain level of operational inefficiency. Traditionally, different locations or departments had autonomy when it came to choosing and implementing software, resulting in a patchwork of vendors and products rather than a smoothly integrated system.
It seems around every corner there is data that suggests growth in cloud solutions is staggering. In their most recent report on "state of the cloud", June 2015, Bessemer Venture Partners, who invest in and have a significant portfolio of cloud solutions, indicated a tipping point has been reached where cloud CRM usage, for example, has surpassed on-premise CRM for the first time in history (more than 50% of CRM is now provisioned as cloud solutions).