How to successfully transition to a cloud QMS December 7, 2019 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. Look for: Integration 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. Shared Resources 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. Continual Improvements 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. Compliance 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. Share via: Twitter LinkedIn Facebook Email
EVENT 9th GCC Regulatory Affairs Pharma Summit (and Quality Conference) 2024 GCC Regulatory Affairs Pharma Summit is an annual event that provides platform for pharmaceutical regulatory experts and industry professionals in the GCC region to share insights and discuss about the latest updates in the pharmaceutical regulations. We are Gold Sponsors of the 9th GCC Regulatory Affairs Pharma Summit 2024. Learn more
EVENT 7th Annual European Medical Device QA & SQM Conference 2024 The 7th Annual European Medical Device and Diagnostic Supplier Quality Management Conference aims to bring together the industry’s top-performing Supplier Quality Management (SQM) & QA QC professionals under one roof. We are Bronze Sponsors of the 2024 Medical Device QA & SQM Conference in Belgium. Learn more
EVENT TUG Americas Join industry peers at one of these FREE events for TrackWise and TrackWise Digital customers, with two dates and locations to choose from. Learn more
EVENT Building a Winning Life Science Eco-system – Leveraging the Quality Link between Platform, Processes and Patients Watch this unique webinar to discover how Life Science organizations can a combine a best-in-class platform with freedom of solution choice to improve product quality, productivity, and supply chain continuity. Learn more
CASE STUDY Empowering Innovation: Revelle Aesthetics Transforms Document Management and Training with TrackWise Digital Revelle Aesthetics selected TrackWise Digital to manage its key quality management processes—document management and training management. Learn more
BLOG The Impact of Digital QMS Solutions on the Life Sciences Industry The evolution of cloud-based quality management systems is transforming expectations and changing realities in the life sciences industry. Find out how in our latest newsletter edition. Learn more
BLOG Integrated Risk Management: Go Beyond Compliance To ensure patient safety, proactively detect signals and trends and continuously improve device quality and safety, integrating quality risk management with the quality management system (QMS) is essential. In our latest article, we consider the benefits of this integration and address the growing complexity of risk management. Learn more
BLOG Cultivate a Culture of Quality: 3 Steps to Getting Started Cultivating a quality culture is critical for any organization's long-term success, regardless of industry or size. Learn more
BLOG The Elements of a Successful CAPA Process To date, the most widely-used and effective process for ensuring safety and quality management is a closed-loop corrective action and preventive action system (CAPA). Learn more
BLOG How Pharmaceutical Quality Drives Performance While many pharmaceutical and biotech companies have begun investing in their quality systems, it’s not uncommon to still find mid-size or emerging manufacturers manually entering data into spreadsheets or using siloed systems that are unable to share information electronically. Learn more
BLOG CAPA Management: Technology to the Rescue If you have been struggling with corrective and preventive action (CAPA) management, it’s possible there is a tech solution that will lift the burden. Learn more
WEBINAR Meeting Compliance and Improving Efficiency with an integrated Quality Management System Join quality experts as they discuss how an integrated QMS can help manufacturers meet compliance while improving efficiency. Learn more
EVENT Quality Systems in the Digital Era: Are You Ready for the Future? Explore how to prepare for the future of quality systems in the digital era with Fabrizio Maniglio, Industry & Business Development Director. Hosted by Quality Digest. Learn more
BLOG The Power of Integration: A Holistic Approach to Quality and Document Management One of the key components for Life Sciences companies is to have their documents and data in order.... Learn more
BLOG It’s Time For The Life Sciences Industry To Embrace Quality 4.0 Sparta’s President and CEO, Oxana Karpenko Pickeral, explores how the Life Sciences industry can address core challenges and connect the “data dots” by embracing Quality 4.0. Learn more