Life sciences companies are used to having tight control over their computer systems, upgrade schedules and validation cycles.
To stand up to the rigor of regulators, many quality and IT leaders have tried to handle everything themselves.
That’s no longer practical, timely or cost-effective in an increasingly connected world.
As manufacturing operations and supply chains expand globally, quality management systems (QMS) need to match their flexibility, speed and integration.
The future of quality management is, as we know, digital.
But there’s some debate over what that means.
Paper documents can be scanned, uploaded and stored in the cloud. At the same time, digital documents can lack many of the benefits technology now affords us.
Documents can be digital, but not smart.
The same applies to cloud-based quality solutions.
When evaluating cloud-based quality management systems, look for features that make them smart, not just digital.
Smart cloud-based platforms aren’t standalone solutions.
To effectively manage quality, your solution should be able to communicate and integrate with systems that produce quality data, like your ERP, CRM, LIMS and others.
An integrated solution can also connect to supply chain and manufacturing data, following your processes from end-to-end.
The saying goes, “More hands, less work.” Cloud-based solutions follow a similar philosophy, but in this case, it’s “More tenants, less cost.” True cloud-based solutions can serve more than one client, when appropriate, so the investment is spread across multiple organizations. Without being able to access each other’s data, companies can share software, storage and computing resources. Smart cloud solutions include both multi-tenant and single-tenant capabilities to address specific business needs.
You don’t wait until the end of a quarter or fiscal year to address quality issues. QMS improvements shouldn’t have to wait either. Cloud-based solutions can be continually improved, providing critical fixes to your implementation instead of putting the burden on your IT team. Top tier cloud solutions come with realistic and extensible processes that grow with your business, including out-of-the-box functionality that’s validated with each release. Look for cloud-based solutions that work on an open platform where IT resources and training are abundant.
A Reliable Investment
If your software is cloud-based and purchased as a service (SaaS), you should be able to reliably predict your monthly or annual software costs. No more budget balancing to account for unplanned hardware costs or expensive maintenance. And since upgrades and validation cycles are near-constant in the cloud, you won’t have surges in IT spending for major releases either.
You shouldn’t have to supplement a digital approach with pen and paper processes to meet audit requirements or pass an FDA inspection. Smart cloud-based solutions are built to meet (or exceed) rigorous regulations. Pick a cloud-based solution that will automatically create an audit trail, meet e-signature requirements and other important compliance essentials.
Moving pen and paper processes (or a legacy on-premise solution) to the cloud is, technically, going digital. But to be competitive and compliant, life sciences companies also need to be smart. By doing so, you’ll gain functionality, integration and control – all at a lower cost.