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GxP Lifeline

"Thriving in a Digital Era, Part 2"


Part 1 of this two-part blog series addressed how the fourth phase of the Industrial Revolution is defined as an era of digital transformation, which is discussed at length in MasterControl’s executive brief: “Architecting for Change: Embracing a Platform Approach.” Historically, organizations have adapted to progress by incorporating new technologies into their existing operations and processes. The digital transformation is compelling companies to modernize their entire IT infrastructure and organizational culture, as well as rebuild their business models in order to sharpen their competitive edge.

A Case for Moving to the Cloud

Launching a startup business commonly involves investing in IT equipment, including an operating system, enterprise management applications, networking capabilities, a data center and servers to support all the IT components. As the business grows, the IT infrastructure needs to scale right along with it. Growth usually calls for additional software, data storage capacity and bigger or more servers to accommodate the growth.

In the life sciences arena, many companies are still running legacy systems on aging IT technologies. This scenario actually imposes more costs and security risks. The more demands a company puts on its IT infrastructure and system tools, the more complicated and costly it becomes. Some examples include:

  • Network performance latency and outages can occur during peak production times.
  • Companies often postpone upgrades, which makes them more lengthy and costly to complete.
  • The need for disaster and security breach recovery is always a possibility — and never convenient.
  • Siloed data repositories and disparate enterprise management tools are fertile ground for inefficiencies, outdated data and errors.

Technology is essential for keeping business operations moving forward and meeting organizational goals. However, the time, effort and costs necessary for maintaining an on-premise IT infrastructure can impede business growth and continuous improvement strategies. Alleviating business obstacles is best achieved by moving your operations to a cloud environment. Cloud-based technology enables a wide range of efficiencies, including:

  • Reduced costs: No need to keep investing in IT infrastructure components, upgrades and storage.
  • Optimal performance: Solution functionality, data backups and security updates are always current, which elevates overall productivity.
  • Faster upgrades: Upgrades are more frequent and require less time and effort to plan and complete.
  • Easier scalability: The cloud easily scales, up or down, depending on your organization’s usage and bandwidth needs.
  • Robust security: A cloud environment is more secure than an on-premise infrastructure. Cloud service providers have engineering teams that focus specifically on cybersecurity. They also have the technology, tools and expertise to ensure around-the-clock security monitoring and incident response, which is something few IT teams can do in-house on top of their other responsibilities.

Software Validation Is Less Burdensome in the Cloud

It’s no secret that software validation can be lengthy and disruptive. It involves planning, completing test cases, gathering data, creating reports and a variety of other tasks. For life sciences companies, software validation needs to be highly risk-focused. This is where operating in a cloud environment is extremely beneficial.

Using a risk-based validation solution, such as MasterControl’s Validation Excellence Tool (VxT), significantly reduces the time and effort required to validate updated software. Specifically, MasterControl customers who use VxT slash 336 hours in overall project preparation and reduce the actual project execution from 104 hours of labor-intensive activities to 20 hours of seamless validation.

Customized vs. Configurable Software

Every organization is unique and operates based on company-defined processes. Understandably, having the ability to customize software, such as for building templates and forms, is a valuable aspect of the technology. However, after decades of customizing tools and tasks, manufacturing, quality and technology experts are finding that customizations are more of an obstacle to productivity.

The main barrier with customizations is they are usually not forward-compatible with future versions of the software. Customized forms are particularly complicated during upgrades because they require extensive preparation, testing and review to ensure they function properly after the upgrade.

Configurable off-the-shelf (COTS) software is functionality that can be created using built-in workflow tools included in the software. Configurable software applications are used by thousands of organizations so developers are able to identify and incorporate updates that are the most beneficial to users. More and more companies are finding that configurable software meets 80 to 90 percent of their industry- and organization-specific functionality needs. In addition, upgrades are faster and more seamless because the software is compatible with future releases.

The Costs of Staying On-Premise

Changing dynamics and aggressive competition is driving life sciences companies to ramp up innovation, improve processes, reduce costs, produce higher quality products and enhance the customer experience. There is always an urgency to achieving these objectives, which makes it easy to overlook the critical technology elements of your business model. An on-premise IT infrastructure with outdated technology will continue to depreciate and age. Legacy systems are prone to inefficiencies, data silos and security vulnerabilities. Ultimately, this scenario is more costly and can undermine your competitive edge.

The cloud is quickly morphing into a strategic tool that connects systems and users, automates processes and maximizes productivity across the whole organization. Best of all, operating in a cloud environment enables companies to channel more time, effort and resources to critical business needs.

Learn more about the technologies and strategies that will make your organization an industry leader, read the executive brief: “Architecting for Change: Embracing a Platform Approach.”


2019-bl-author-david-jensen

David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.


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