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Fully Managed Cloud Solutions For Life Sciences Organizations 

In Life Sciences, each step is crucial on the path to success. 
GET THE EDGE with our proven experience. 

Validated Cloud For Life Sciences 1For over a decade, Outer Edge has specialized in designing, managing and assisting clients to validate cloud-based systems in regulated industries. We partner with our customers to implement strategies to reduce capital expenditures and drive operational efficiencies all while complying with applicable regulatory requirements. Additionally, we routinely assist our Life Sciences customers to satisfy their compliance requirements by providing the documentation and audit trail necessary for their IQ & OQ validation process. 

Cloud Infrastructure Designed For Life Science Organizations

There are many Cloud Services Providers (CSPs) to choose from. But not all CSP’s are created equal. When it comes to selecting a CSP, experience and qualifications matter.  That’s why Outer Edge should be at the top of your list when it comes to your cloud computing needs.

Outer Edge has been in business for more than a decade and boasts a deep, experienced bench of  IT subject matter experts ready to assist with projects ranging from the design, implementation  and management of cloud strategies to the design, delivery and management of robust data recovery solutions.

Outer Edge has audit-ready quality systems in place that are ISO 9001: 2015, CFR Part 11 and GAMP 5 complaint, has been SOC II accredited since 2015 and routinely works closely with its customers to facilitate the validation of regulated IT environments.

Don’t let the performance and security of your IT networks and infrastructure prevent your business from surviving and thriving in the age of the remote workforce. Call us today to schedule an appointment to learn more about the Outer Edge difference.

System Validation

Every one of our cloud-ready environments is built to support 21 CFR Part 11 & Part 820, Annex 11 and GAMP 5 compliance and has the following characteristics:

  • System Documentation / Build Documents
  • Change Management Controls
    • Active participation in the Change Management Process
    • Change Request / Approval / Implementation / Documentation
  • Encryption while data is in transit and at rest
  • Optimized Network Design
  • Storage
  • Security and System Access
    • System Access / Delegated Security Configuration
    • Physical Security
    • Network

Once on board, we consider ourselves a part of the customers’ IT team.  Our engineers routinely participate as valued members of our customers’ strategy and change control efforts among other things.

Our expertise and dedication to the Life Sciences industry enables us to host the infrastructures of many of the common applications outlined in the Purdue Model (Enterprise, DMZ, Manufacturing, and Cell/Area zones).

Here are a few of the current Life Sciences instances within our Life Sciences portfolio.

  • Laboratory Information System (LIMS)
  • Stability Systems (SLIM)
  • Manufacturing Execution Systems (MES)
  • Plant Maintenance/Calibration Management Systems (CMS)
  • Building Automation Systems (BAS)
  • Statistical Analytics Software (SAS)
  • Enterprise Resource Planning (ERP)
  • Clinical Trial Systems
  • Environmental Control Systems

Likewise, our experience working with the vendors of each respective application provides the necessary technical interface ensuring a smooth and seamless onboarding process.

We follow Best Practices for infrastructure design and management and are SOC 2, Type II certified. Every Outer Edge design includes the critical components necessary in a regulated Best Practices Life Sciences environment:

  • Security (Network, Storage, Access)
  • Redundancy (Hardware, Network)
  • Data Retention, Archive, Backup & Recovery
  • Latency Optimization (Network, Storage)

Validated Cloud For Life Sciences 2

It seems obvious to us, but we often see designs that are missing one or two of these key components.

Our engineers have an average of 20 years of experience in each of these respective disciplines ensuring all facets of your IT environment will be properly considered, designed and implemented.

Outer Edge offers multiple IT environment options and partners with world-class vendors to best align your Quality system with your business needs. In addition to providing our own private cloud offering, we also design and manage environments in AWSMicrosoft Azure, and customer on-premise infrastructures. This enables us to seamlessly spin up global environments and model out multiple scenarios for each customer and help them determine which cloud options suits them best.

In the Life Sciences business, falling behind is not an option. You need Partners with experience to keep pace with the expectations of clients, stakeholders and regulators.

Contact Us

Outer Edge Technology, LLC
201 King of Prussia Road, Suite 650
Radnor, PA 19087
Phone: 844-OET-EDGE
Email: info@outeredge.biz

AICPA

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