Here is the inside story on the recent TrackWise 9 QMS Software release. This interview was conducted by Gregg Klein, Director of Product Management and the responses were given by Mike Edwards, Product Manager for TrackWise.
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”.
On November 8, 2016, the FDA released final guidance on Medical Device Reporting (MDRs). MDR is a critical quality component of a company’s complaints management system. All manufacturers of legally marketed medical devices in the US, including foreign manufacturers who export devices to the US, are subject to it.
Regulatory oversight for drug manufacturing has significantly increased due to product quality issues in the pharmaceutical industry. This can be attributed to significant growth of new drug applications with broadening global sourcing and distribution.
This is part three of an ongoing series of posts from Mohan Ponnudurai as he attends and speaks at quality shows and conferences across the globe.
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.