Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company
Life Sciences organizations are progressively searching and shifting to cloud-hosted environments to increase efficiency and reduce costs. But to do so, those organizations must be able to select a cloud service provider that helps to assure the confidentiality, integrity, and availability of data stored in the cloud.
Cloud-hosted environments help Life Sciences organizations with validation challenges and ease the process of qualifying cloud infrastructure with emerging capabilities and tools. In addition to the methods and controls to support the achievement of continuous quality and regulatory compliance, these organizations are seeking ways to maintain their Quality Management Systems (QMS) in a secured and validated state.
Cloud-based companies are becoming a more viable alternative for the Life Sciences as cloud models offer robust security models and proven high reliability of data integrity. The cost-effectiveness of cloud hosting helps these companies significantly reduce the challenges associated with the implementation, validation, and maintenance of complex applications when using their scarce resources.
Cloud Validation Can Simplify Compliance
Cloud-based providers have taken new approaches towards validation that not only meet industry and regulatory requirements, but provide higher-quality results. Life Sciences professionals should look for a cloud-hosted provider that offers the ability to exceed customer expectations with regard to the controls required to ensure software security, data integrity, compliance with customer procedures, and regulatory requirements. Organizations must combine challenges with today’s realistic solutions to ensure sustained compliance and governance. These benefits have successfully facilitated the transition of QMS to the cloud.
To get the most significant benefit from a cloud-hosted model, Life Science industry experts need to identify the extent of the validation scope and impact, and understand the financial and resource impact of the validation process. Think about the cloud service diagram below: for non-cloud hosted QMS, the nuisance of the qualification and validation level can be burdensome and should not be deferred from the estimated timeframe.
Validation Benefits of a Cloud-Hosted QMS
When a QMS exists in a cloud-hosted, licensed (subscription) software delivery model, refer to the system management and process as Software as a Service (SaaS). In a cloud-hosted environment, a SaaS solution provides a practical option by which cloud service providers can offer more application- and user-oriented services.
The high cost and effort required to deploy and implement a new, on-premise QMS, or the risks associated with upgrades and fixes, may result in greater upfront costs and resource allocation. By leveraging cloud-based SaaS offerings to manage a QMS, service providers can significantly boost the odds of success, reduce cost and effort, and manage upgrade on behalf of the customer.
SaaS solutions can reduce risk in a number of areas and help to overcome hurdles. Life Sciences customers adopting a cloud-hosted QMS are responsible for fewer operational activities associated with managing an application, compared to the responsibilities of on-premise deployments. Organizations can now achieve on- premise compliance levels in a cloud-hosted environment — without the high costs, delays and headaches of on-premise efforts.
One of the most significant advantages that cloud-hosted service providers can offer for SaaS solutions are validation and delivery of SaaS QMS with minimal cost, time, and risk. During validation, the key for deploying cloud-hosted solutions is to define the right process of capturing validation documentation by the company’s internal procedures in alignment with regulatory requirements and business practices.
Qualification and Validation Due Diligence
Key regulatory requirements and guidelines, such as FDA Part 11 and the EU’s Annex 11, have a common goal to ensure that quality systems involved in the manufacture of pharmaceutical products and medical devices are adequate and can achieve product and patient safety through data integrity and availability with proper security levels. Life Sciences manufacturers won’t gamble on investing significant resources into a new cloud-hosted system that must be validated.
A compliant cloud-hosted solution provider should assist customers in surpassing and outperforming the qualification process of its underlying infrastructure. Pilgrim Quality Solutions helps its customers ensure that the underlying cloud infrastructure is secure, documented, and maintained in a controlled qualified state. System qualification is traditionally achieved by following two processes—Installation Qualification (IQ) and Operational Qualification (OQ). Once the system requirements are determined, verification methods are performed to assure that the minimum-security and application baseline is met.
While there are many differences in how qualification occurs, QMS validation does not change. A QMS should go through the standard system development lifecycle (SDLC), across non-production and production environments. However, within a validated cloud environment, consistency throughout the SDLC is ensured.
The most significant challenge that the Life Sciences industries have with validating cloud-hosted QMS is in translating industry regulatory requirements to the providers’ services. Another significant problem is the lack of understanding of cloud technologies inside many Life Sciences compliance teams. By leveraging a GxP-compliant cloud-hosted environment, organizations will benefit from compliance and hosting knowledge of the provider.
Pilgrim Quality Solutions has followed a validation approach when developing and implementing SmartSolve® as a cloud-based Quality Management System solution for Life Sciences customers. This includes creating and executing IQ documentation for products and releases, and validating the system functionality, through running OQ scripts from an in-the-box released solution perspective.
Pilgrim’s computer system validation documentation ensures that SmartSolve, as a cloud-hosted QMS, is accurate, reliable, and consistently performs as intended. While this sounds very complex, it is manageable as Pilgrim’s affordable cloud-hosted environment is entirely consistent from both a hardware and system software standpoint. Pilgrim provides validation, quality, and implementation services for some top Life Sciences organizations to realize significant quality and compliance benefits.
A cloud-hosted solution is more than a technology upgrade. Cloud-hosted services are the best possible strategy to meet eminent data storage and processing demands with expanded capabilities to meet the demands for varied, huge volume data in cloud storage and processing capacity. Cloud validation is a challenge; however, following FDA and GAMP guidance, Pilgrim has demonstrated for more than a decade that it is possible to utilize the Cloud in a GxP-regulated environment, and thus, assure the benefits that a cloud-hosted environment offers.
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