While every industry is facing increasingly stringent levels of regulation and oversight, none is more tightly regulated than healthcare and pharmaceuticals. In a context of highly complex day-to-day operations, the central risk to patients’ lives that poor processes can pose is coupled with the risks of financial and reputational damage which come from regulatory non-compliance. Achieving and maintaining regulatory compliance can also lead to growing overheads which, stacked on top of a challenging business environment, can threaten agility and competitiveness.
This difficult business environment is due to a variety of causes: the demand for personalised medicines and treatments; aging populations placing stress on key services; and patients taking more control over provider choices. In the midst of this complexity, digital transformation (DX) lies at the heart of healthcare businesses’ internal conversations.
By adopting methodologies which arose in software development, healthcare and pharmaceuticals companies are not just cutting costs, but creating a competitive edge by de-siloing business units and channelling man-hours away from routine processes and into high-value labour. However, the unique nature of the sector means that there are particular considerations to make when embarking on DX in a healthcare business.
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Replacing paper-based record management with Electronic Record Management
Paper trails are a vital part of healthcare development, providing a body of evidence to regulators which needs to be airtight. However, traditional paper-based record management risks data inconsistency or duplication and offers limited search visibility.
As such, electronic records are an obvious first DX step – but a thorough paper trail demands more than just a database. If the chosen solution doesn’t automatically generate audit trails, then tracking changes will be a significant effort later on.
Electronic signature embedding is also a vital feature for directly submitting electronic data for inspection. Finally, any tool dealing with patient records must be highly secure and any third-party vendors used should have solid security compliance.
Turning the GAMP V-model into continuous validation
Good automated manufacturing process (GAMP) is a very familiar set of guidelines for those in the healthcare and pharmaceutical industry, and an important component of safety verification. However, GAMP can traditionally take months and risk late discovery of issues which send you back to square one.
As with the software industry, the time-consuming V-model of validation, in which an application is developed in increasingly specific phases and then tested in reverse order, can be effectively replaced with the continuous validation pipeline found in Agile and DevOps environments. Here, changes to the application trigger automatic build and test processes which revalidate the system.
Building validation into implementation can result in verification process taking days or hours, not weeks. Of course, this build and test process must also generate an adequate paper trail, with a reporting tool which renders data in the form required by auditors.
Shifting-left your security and performance testing
Regardless of which category your software falls under in the GAMP 5 classification, the validation requirements will include not just safety, but also security and performance metrics. As these validations have often been seen as difficult, with few opportunities to run them, they are pushed to the end of an already long validation process.
When implementing continuous validation, businesses can also institute shift-left practices which incorporate security and performance testing into the functional testing process. Earlier problem discovery avoids the need to repeat validation steps later in the process.
Managing patient relationships with a good mobile app
The growth of personalised medicine and patients’ control over their treatment journey demands better ways of passing data down to patients and more effective tools for patients to communicate the decisions they then make. Building a good public-facing mobile app is no longer just preferable; it is a business essential.
Mobile apps always pose a design and implementation challenge, as they have to accommodate a seemingly infinite variety of devices and operate smoothly under unpredictable network conditions. The critical nature of health-related apps demands a highly robust testing solution which can account for less common devices, offer network virtualisation tools to simulate real-life mobile network conditions, and thoroughly evaluate user experience and accessibility.
Consolidating development data into one repository
One of the key sought-after benefits of DX is the opportunity to generate insights from data which would not otherwise be easily accessible. For healthcare companies, data produced by the research and development process is highly valuable, and that value can be unlocked by storing the data in a central management system.
However, due to their nature, medical devices and medicines produce huge amounts of data, often at the point of use, which can make collection and consolidation difficult. Even with a management system, this data may need to be collected and entered manually, creating delays, inaccuracies, and overhead. It is therefore important to consider finding a system with a mobile client that people can take to any site, and which has offline working capabilities, to help maintain a clean and complete repository. As we all know, intelligent data collection is the basis of insightful analytics.
In many ways, the complex nature of the healthcare and pharmaceutical industries make them particularly ripe for DX initiatives: automated tools have huge potential in rigorous regulatory environments where record-keeping is paramount. While the sensitive nature of the sector demands thoughtful forward planning, the competitive advantage it can generate is more than worth the effort.
Ying Lei, Product Marketing Manager at Micro Focus (opens in new tab)
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