Robert Gaertner, director of strategy for quality at Veeva Systems in Europe, reveals the top five reasons why quality management should be moved to the cloud.
On cloud five
Many organisations around the world are making the transition to software-as-a-service and embarking on new cloud technology initiatives. In fact, by 2020, more than $1 trillion in IT spending will be directly or indirectly affected by the shift to the cloud, according to Gartner.1
In life sciences, an industry that has lacked software innovation for decades, it is no different. A key area that can benefit from modernisation with cloud-based technology is quality management. In line with IHC Q10 guidance for more holistic and effective quality systems, organisations are looking to simplify and improve access for better visibility and control of GxP-critical processes. As a result, organisations are replacing outdated technology with modern cloud solutions to improve productivity and reduce quality risks.
When it comes to modernising quality management, key aspects such as a single source of truth, data integrity across multiple sites, and external collaboration are highly valued in the life sciences industry. However, many solutions on the market masquerading as ‘cloud’ aren’t truly cloud or purpose-built for GxP areas. In reality, these solutions are often existing applications simply offered in an online hosted model. In other words, these applications are online versions of legacy software, and therefore do not deliver all the benefits of an industry cloud.
What’s the difference?
The defining attribute of a true cloud solution is multitenancy. Multitenancy enables the secure deployment of only one version of cloud software to all customers. It supports quick, ongoing innovation that minimises the IT and validation burden. In contrast, legacy software hosted online requires the application supplier to maintain multiple versions of the software, which can result in infrequent upgrades that are time consuming for customers to implement.
Here are five characteristics of an industry cloud solution that address today’s needs for manufacturing quality.
1. Complete
A unified cloud-based suite brings together multiple solutions, such as quality management system (QMS) and document management for improved control, visibility and partner collaboration. Harmonising globally on a single system means processes and document templates can be standardised, reducing the risk of errors or duplication.
2. Inclusive
Organisations can bring external stakeholders into internal business processes easily and securely to reduce manual efforts and improve collaboration. A multitenant cloud solution gives any authorised user access from any device, at any time, from anywhere, which enables harmonisation of different business processes. For example, with a unified cloud-based QMS and document control solution, when changes are made, all parties are involved and can collaboratively solve the problem.
3. Innovative
With a multitenant cloud solution, the provider makes continual investments to deliver ongoing application updates and keep up with the latest industry best practices. This increases the agility of business and IT and shifts the focus to fine-tuning the applications to align to the business needs. In addition, industry cloud solutions for GxP areas means all applicable regulations, such as 21 CFR Part 11 and EU-GMP Annex 11 are fulfilled, including a full validation program.
4. Intuitive
Multitenant cloud applications are intuitive and easy to use. For example, managing document lifecycle and taking documents from draft through review, revision, approval, issuance and training is simplified with an industry cloud solution, which encourages user adoption. A good user experience in turn will result in users consistently working within the system, helping to drive quality and improving return on investment.
5. Accurate
Users can easily view the real-time status of activities and conduct ongoing analyses to identify areas for improvement with a unified cloud-based quality management system. This makes it easier to generate recurring regulatory reports or satisfy the upcoming need for submitting quality metrics. For example, companies can run reports on a wide range of QMS metrics across their enterprises so they can anticipate potential bottlenecks or compliance risks well in advance. This shifts an organisation from reactive to proactive and can positively impact business areas beyond compliance.
Ready for an industry cloud solution?
The transition to the GxP-regulated cloud will continue to gain momentum. With multiple cloud options available, at first glance it may seem difficult to decide on the best solution. However, a true multitenant industry cloud solution purpose built for life sciences has unmistaken benefits that can’t be matched by online legacy applications.
With all users working on the same platform, in a system that allows for secure collaboration and increased visibility, the productivity and efficiency gains are considerable. And it is the cloud solution provider who manages software updates and ensures the applications stay current with regulations. This means you can realise true change — without needing to upgrade your software first.
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