By Ying Lei
The healthcare industry is known for being one of the most regulated, with an understanding of the high complexity that goes into its day-to-day operations. Aside from putting patients’ lives at risk, there’s incentive for companies to comply with these regulations as failing to do so could hurt a business monetarily as well as from a reputational standpoint. However, achieving and maintaining regulatory compliance can also result in increased overhead as the business environment becomes more challenging.
In the midst of this growing complexity is a call back to efficiency, and what better way to start than with a digital transformation? Here are several things to consider before getting started with a digital transformation for your healthcare company:
Incorporate Electronic Record Management
When choosing software to manage your pharma records in electronic form, look for EBR software that is a highly powerful and low-cost pharma-specific tool that will help to meet the needs and budgets of practically any sized pharmaceutical manufacturer. Additionally, workflow with embedded electronic signature functionality is a must if you want to directly submit electronic data for inspection.
From the GAMP V-model to Continuous Validation
If the GAMP V-model validation process is done with a Waterfall approach, validation for an on-premises system can take months. There is a high risk of late discovery of issues and when changes need to be made to the system, re-validation can be time consuming which in turn has the potential to slow down operations.
With the increasing popularity of Agile and DevOps practices across industries, it’s time to adopt a Continuous Validation approach. By setting up Continuous Validation pipelines, any change will trigger the process of automatic build and test, with re-validation occurring whenever there is change to the system. This process can be repeated continually without pain, and each validation finishes in days, or even hours/minutes, depending on the scenario.
Shift-left on Testing
Regardless of which category your software falls in the GAMP V classification, the validation requirements will involve security and performance items. Traditionally these validations are difficult and infrequent in the amount of times they can be run. As a result, they are pushed to a later stage in the already long validation process.
In implementing Continuous Validation, it is important to incorporate security and performance validation into the pipeline with all stages covered through shift-left practices. Early discovery of these issues will allow for teams to avoid repeating tedious validation steps.
Manage Patient Relationships with a Mobile App
In this increasingly competitive industry, a good public-facing mobile app has become more than essential for interacting with patients, but developing an app has its own set of challenges. Make sure to choose a mobile testing solution that supports the large variety of available devices, along with providing the network virtualization to simulate real-life mobile network conditions.
Merge Development Data
Due to their nature, medical devices and medicines produce large amounts of data in their typical lifecycle. Even with a management system, such data may need extra work to be recorded on-site (with paper or other media) as it must be manually entered into the system and linked to the related requirement.
In choosing your management solution, look for a mobile client of the system that people can take to any site for testing and working offline. Doing so will save your team a significant amount of time on consolidating data as good data collection forms the base for additional insightful analytics.
In closing, the complex nature of the healthcare industry makes it an excellent candidate for a digital transformation. The highly regulated landscape can only benefit from increased efficiency and it is in the best interest of decision makers to see how the use of automated tools will assist in an industry where record-keeping is of the utmost importance. Through the adoption of electronic record management, the implementation of continuous validation, the shifting left on security/performance testing, the development of a dedicated app and the consolidation of development data, healthcare businesses can take advantage of improvements to get a more complete view of their available data.
Ying Lei- Application Lifecycle Management Leader at Micro Focus
Ying Lei has over 25 years of enterprise software experience. She has worked on many different roles and software products, through which she gained a good understanding of how IT systems work to achieve business goals. Ying holds a master’s degree in computer science from the University of Electronic Science and Technology of China.