4 Signs Your Quality Team Needs QMS Software

4 Signs Your Quality Team Needs QMS Software

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.

Benefits of Cloud QMS in a GxP Environment: Part 1

Benefits of Cloud QMS in a GxP Environment: Part 1

Cloud applications have many well-known advantages over traditional on-premises applications: reduced time to benefit, lower costs, scalability, integration, faster upgrade cycles, and ease-of-use.  

Quality and the Digital Enterprise

Quality and the Digital Enterprise

Analysts predict that by 2020, there will be more than 50 billion connected devices, impacting industry and our daily lives. From mobile devices and wearable technology to cloud computing and IoT platforms, think about the data being generated and how it’s being leveraged to gain business insights and create new customer experiences.

Agile in a Regulated Environment

Agile in a Regulated Environment

Agile is a mindset that should be adopted by every organization.  The goal or principle of Agile isn’t scrum, but just another way of building a rapid-learning loop. 

6 Tips for Effective Quality Systems

6 Tips for Effective Quality Systems

The global life sciences industry is rapidly focusing beyond a culture of compliance to a culture of quality.

Fundamental to this shift is a manufacturer’s ability to provide regulators and executives with greater visibility into its operations and quality processes.

Three Tips for Choosing a Cloud Quality Management System

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”.

 

Navigating Your First 100 Days as Head of Quality

Navigating Your First 100 Days as Head of Quality

You finally landed your dream job as head of quality. But things are about to get a lot harder. Here’s how you can succeed in your first 100 days.

Where in the World is Mohan Ponnudurai..... Mumbai, India, 29-30 Aug 2016

Where in the World is Mohan Ponnudurai..... Mumbai, India, 29-30 Aug 2016

As part of UBM's series of conferences and seminars in India, the latest was on Unannounced Audits, held at the Westin Garden City in Mumbai on August 29 & 30. Sparta Systems was one of the sponsors and I was one of the presenters.

Building a Quality Metrics Strategy to Increase Product Quality

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.