Life sciences organizations, including pharmaceuticals, and medical device manufacturers, constantly look for ways to reduce risk, increase patient safety, and achieve operational excellence. To be successful in these three areas, pharmaceutical and medical device manufacturing companies need to have robust management systems in place. This is even more critical than in other industries where the breadth of regulatory requirements is not as vast.
Transforming their QMS to the cloud can help them achieve these strategic objectives. Along this digital transformation journey, software validation can be a challenge with varying degrees of intricacy across organizations. Causes can range from lack of experience and expertise to the complexity of internal and external stakeholders involved. Ultimately, no one wants to receive a 483 from the FDA due to noncompliance with 21 CFR 11, which will put an organization in a bind and ultimately impact patient safety.
As pharmaceuticals and medical device manufacturers look to overhaul their archaic QMS tools, they need to identify technology partners that have experience with validation and offer a comprehensive offering that will address their needs in the short term – and beyond. They also need to rely on partners that can help them maintain their validated systems as changes and improvements need to be implemented over time. Let’s look at four reasons why life sciences organizations are moving their QMS to the cloud.
REASON # 1: REDUCE TECHNOLOGY SOFTWARE & HARDWARE OVERHEAD
Considerations such as what type of cloud QMS infrastructure should be used should be top of mind. Depending on the needs of the organization, they may want to invest in SaaS (Software as a Service, or software used in a cloud environment), PaaS (Platform as a Service, a configurable platform in a cloud environment), or IaaS (Infrastructure as a Service, where hardware is essentially outsourced). With each approach, there is an opportunity to reduce costs, scale access to tools, and free up resources to focus on strategic initiatives rather than being tied up with supporting operations.
REASON # 2: A CLOUD FOR EVERY ORGANIZATION
Various cloud environments are available. The Private Cloud is a dedicated environment for a single customer which helps to increase the level of control over changes to the environment. The key criteria for any hosting environment is to be in a controlled environment. This has implications for the processes that the hosting provider and software vendor must have to ensure that validated systems can maintain their validated state.
Another type of cloud is the Community Cloud. Here, various customers share the same environment and there are provisions in place to manage potential changes that could impact each client. A change control process helps facilitate assessments by the client to assess the impact of any potential changes to their validated system. If the risk assessment determines that there is a need to re-validate, this must be done.
Validation environment needs to be in a controlled setting. Another variant of this environment is the Public Cloud, which contains many customers on a single hosting instance. Additional measures must be taken from both the cloud provider and software vendor to help organizations maintain their validated state.
REASON # 3: OPEX vs. CAPEX
Getting funding for new technology can be a challenge. Traditional approaches to place a significant investment up front is a way of the past. With SaaS, PaaS, and IaaS, organizations can now hedge their financial investment in their solutions. They can easily budget on an annual basis with this approach and no longer have to pay for a very large investment up front that might not pay off if the wrong technology partner is selected. An annual licensing model allows organizations to easily walk away from their contracts if they are not receiving their expected return on investment. This is great for both customers, cloud providers, and software vendors, as it keeps everyone honest and focused on doing what’s right for customers.
REASON # 4: SCALE THE BUSINESS
Cloud software technologies enable large pharmaceuticals and medical device manufacturing multinational corporations to deploy enterprise-wide solutions with minimal IT investment. This also helps those involved with supporting IT implementation projects. Rather than having duplication of siloed tools being implemented across the globe, a single cloud technology can address the needs of many business units and leverage a global resource base. This approach is also beneficial as global best practices can be incorporated and standardized with this broader project team and global user base.
Validation is a core requirement for any computerized or automated system used for production or the QMS in life sciences organizations. Reliable partners and technologies to help scale these organizations are essential to increase efficiency, collaboration, and patient safety. With your next validation initiative, take more of a partnership approach to validation. It’s crucial to have robust quality agreements with all involved stakeholders. When those are in place, all organizations involved can support the ultimate objective: reducing patient exposure to hazards. To learn more about this QMS and validation for the life sciences industry, view Intelex industry page.