Obtaining IQ Validation Evidence for FDA Compliance when Leveraging Cloud Services

Simplify FDA Validation of Mission Critical Apps in the Cloud

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Life Sciences Company Eliminates IT Distractions by Leveraging the Expertize
of a Cloud Service Provider to Design, Build, Manage and Implement a Validated, Secure, Responsive Cloud-based MES System

For companies focused on ramping up quickly, the prospect of diverting or procuring additional IT resources and spending time designing, building and managing regulated IT infrastructures doesn’t make sense. Rather, trusting and partnering with an expert Cloud Service Provider (CSP) like Outer Edge Technology, which is focused on the Life Sciences vertical, to design, build and manage qualified
infrastructures and host validated applications, is the better option.

In a recent implementation, Outer Edge Technology delivered best-of-breed MES and other mission critical applications through cloud-based infrastructure—meeting the security, regulatory and performance requirements for one of its Life Sciences customers. The successful project offers new options for highly regulated bio-pharma and other manufacturing companies who understand the strategic advantages of cloud-based infrastructure. Outer Edge has demonstrated that the cloud can support the performance, regulatory and security requirements for mission-critical applications historically designed and implemented exclusively via on-premises deployment.

Bridging the cloud divide

The mature, full function MES applications that can support the exacting requirements of the Life Sciences industry were historically built exclusively for on-premises deployments. They have been developed over many years to meet specification, execution, compliance and manufacturer intelligence requirements in a fast-changing industry. And while software vendors are working diligently to move their
applications to modern SaaS models, they are not market-ready. As a result, companies have been forced to procure, maintain and manage expensive, in-house IT infrastructure to support many best-of-breed mission critical applications. To bridge the divide, Outer Edge engineers designed a cloud-based infrastructure specifically tailored to meet the exacting performance, compliance and security requirements of MES and other mission critical applications utilized in the Life Sciences and other industries.

Responsive end device processing

Early in the project, the performance requirements to support data collection from testing and manufacturing process equipment and monitoring devices were analyzed and addressed. Data collected through digital equipment for weighing, measuring, monitoring devices and more must be instantly available. Outer Edge designed the cloud-based infrastructure to provide the performance and redundancy required to meet the critical nature of endpoint responsiveness. Critical to the success of highly regulated manufacturing is the assurance of secure, responsive data connections to production and monitoring equipment.

Data protection by experts

The growing sophistication of hackers is driving manyorganizations to the cloud so they can take advantage of highly secure, continuous, expert data management. Threats from both inside and outside the organization need the full attention of dedicated security resources and expertise. Working with multiple platforms, including AWS®, Microsoft Azure® and its own private cloud, Outer Edge objectively
evaluates the compliance and security requirements to best support each company’s unique situation. Through regulated, cloud infrastructure design, data is secured and protected with cutting edge technology tools.

Best-in-class mission-critical applications without compromise

With a CSP partner like Outer Edge, Life Science and other manufacturing organizations can get the full value of validated, mature, high-function applications without the associated IT headaches. Outer Edge Technology professionals work diligently with their clients to clearly define requirements. Collaborating closely with security and technical teams, every layer of an infrastructure is evaluated, defined and engineered to meet its customers’ unique requirements.

With cloud-based MES, organizations can focus more resources on research and production.

Choosing the best combination of public and private cloud configurations, Outer Edge engineers develop and deploy solutions which deliver high availability, security and speed. Architecture is designed to meet not only industry requirements, but also to ensure full confidence at every level of the organization. At Outer Edge, we are helping clients realize strategic advantage with dependable, cloud-based technology and personalized support.

We offer:

  • References for successful regulated cloud deployments and ongoing management.
  • Full redundancy, vigilant security and performance monitoring with high data availability and integrity.
  • We work with Quality teams and provide the I/Q evidence necessary to facilitate the validation of the application running through our quality systems
  • Data security processes that support full regulatory compliance in addition to enhanced disaster recovery and business continuity.
    Strategic guidance to evaluate network designs and improvements to keep pace with ever-changing technology.
  • Complete managed technology services including LIMS, MES, Stability Systems, Calibration Management, Building Automation and other LOB applications specific to highly regulated manufacturing businesses.

Outer Edge provides personalized private cloud application hosting and ongoing managed IT services for businesses ready to outsource
foundational infrastructure. In addition to our own private data centers, we support on premise, AWS® and Microsoft Azure® environments.

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