Cloud-based QMS Launches in Australia

The cloud-based quality management system (QMS) offered by MasterControl is now available in Australia. With the country’s pharma and medical device manufacturers growing rapidly, this new offering is a means to stay ahead of the competition.

To keep up with the speed of industrial advancement, businesses around the world are seeing the importance of engaging more with technology. Those in life sciences product manufacturing are transitioning to the cloud because it offers a cost-effective solution with unparalleled benefits. As such, companies are revising their business models to adopt strategies for converging organisational business units, gathering and using more data and encompassing automation and artificial intelligence (AI).

Innovation, discoveries and novel business opportunities are emerging everywhere. While the advancements are impacting numerous areas in all industries, the core of all the progress and growth is cloud technology.

MasterControl recently published “The Ultimate Guide to Cloud Technology,” which details the various aspects of cloud computing and clarifies why it is essential to a company’s business model and long-term strategy.

The Digital Future Is Here

The cloud is no longer thought of as an elusive and ambiguous technology environment. It has evolved into a mainstream computing infrastructure offering:

• Extensive computing power.
• Abundant data storage.
• Scalability.
• Stability.

This type of IT infrastructure is becoming an indispensable accessory to business operations. The following are a couple of industries that can no longer function without the cloud.

Financial

A typical financial institution’s computing and data center needs fluctuate often throughout a given year. Aligning predicted and actual infrastructure needs is rare, making budget forecasting difficult. Because all industries intersect with financial institutions, out of necessity, the average financial services firm reportedly uses 1,004 distinct cloud services.₁

Telecommunications

Businesses need interconnectivity to communicate and exchange large amounts of data. As such, there is a heavy reliance on the telecommunications industry. Even the simplest processes and transactions in on-premise IT environments are difficult when departments and users must:

• Compete for bandwidth.
• Contend with unpredictable server performance.
• Use unsecure methods to transfer data files.

Computer systems and software applications are bigger and more complex. The need for fast and reliable cloud technology is becoming a business imperative.

Why the Life Sciences Industry Favours Cloud Technology

The life sciences landscape is undergoing a major transformation — employee skill sets, regulatory processes and products are changing dramatically. Businesses in this industry are taking advantage of available technologies to foster more convergent, forward-looking company cultures. As a result, they are more unified and collaborative with regulatory bodies.₂

Regulatory Agencies Advocate Modernised Technology

Global regulatory agencies are endeavouring to ramp up key regulatory measures to match the pace of next-generation technologies.

• FDA modernises 510(k) – A new proposal from the U.S. Food and Drug Administration (FDA) aims to modernise the 510(k). The incentive is to ensure that new medical devices entering the market through the 510(k) pathway either account for advances in technology or demonstrate that they meet more modern safety and performance criteria.₃
• Medical Devices Regulation (MDR) – The Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are intended to increase the transparency of the approvals and usage of medical devices. Also, to improve patient experiences and outcomes. ₄
• FDA leads by example – The FDA is taking a big step toward modernising its technology infrastructure. The agency’s Technology Modernisation Action Plan (TMAP) involves migrating its IT infrastructure to the cloud. The intent is to bring the organisation up to speed with the latest technologies in order to expedite breakthrough discoveries and greatly improve public health.₅
• General Data Protection Regulation (GDPR) – Data gathering, storage and transmission technology continues to advance. For this reason, the European Union (EU) Parliament enacted the General Data Protection Regulation (GDPR). The intent is to better protect personal data belonging to clinical trial participants and health care patients.₆

Head Start on Being Data-Centric

Regulated companies rely heavily on having comprehensive and up-to-date data to achieve regulatory compliance. This means a company’s business model needs to be highly data centric.

The cloud’s integrated platform fully encompasses all the fit-for-purpose tools and resources needed for regulatory compliance. For instance, MasterControl Manufacturing Excellence™ streamlines compliance by helping your operations to go 100% paperless. You can create productive connections between enterprise systems, data sources, processes and people throughout your entire organization, for a holistic view of data. In doing so, you ensure that:

• Data is entered into the system correctly.
• Cycle times are improved.
• Review times are reduced and product gets to market faster.
• Manufacturing operations and quality priorities are unified.

You can ensure manufacturing documents are complete and accurate, which allows you to access the information needed to make data-driven business decisions.

Painless Validation

Anyone who has ever been involved with software validation likely has a few choice adjectives to describe the process: arduous, disruptive, time intensive, etc. Fortunately, validation is adapting to take advantage of cloud-based technology.

MasterControl’s cloud platform includes the patented Validation Excellence Tool (VxT)™ (U.S. Pat. 10,324,830). Validation tasks, such as installation qualification (IQ) and operational qualification (OQ), are completed by MasterControl, which significantly reduces the time and effort needed to complete the validation processes.

Emerge as an Industry Leader

Businesses need to leverage the most advanced, innovative technologies to stay competitive. Operating in a cloud environment gives you the assurance of reliability, maximum uptime and comprehensive security in your IT infrastructure. As a result, your company can strengthen its position in the market and deliver more value customers.

To learn more about cloud technology and its advantages, download “The Ultimate Guide to Cloud Technology.”

References

1. “Financial Services Firms Increased Their Cloud Usage by 32.1% in 12 Months,” Skyhigh Networks. https://www.skyhighnetworks.com/cloud-security-blog/financial-services-firms-increased-their-cloud-usage-by-32-1-in-12-months/
2. “The Challenge of Compliance in Life Sciences: Moving from Cost to Value,” Deloitte. https://www2.deloitte.com/content/dam/Deloitte/uk/Documents/life-sciences-health-care/deloitte-uk-challenge-of-compliance.pdf
3. “Statement From FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on Transformative New Steps to Modernize FDA’s 510(k) Program to Advance the Review of the Safety and Effectiveness of Medical Devices,” U.S. Food and Drug Administration (FDA), Nov. 26, 2018. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and
4. “The European Union Medical Device Regulation of 2017,” EU MDR. http://eumdr.com/
5. “FDA’s Technology Modernization Action Plan,” U.S. Food and Drug Administration. https://www.fda.gov/about-fda/reports/fdas-technology-modernization-action-plan
6. “Regulation on the Protection of Natural Persons With Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data Protection Regulation),” The European Parliament and the Council of the European Union, April 6, 2016. http://data.consilium.europa.eu/doc/document/ST-5419-2016-INIT/en/pdf