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.
For 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 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
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 Change Management Process
- Change Request / Approval / Implementation / Documentation
- Encryption while data is in transit and at rest
- Optimized Network Design
- Security and System Access
- System Access / Delegated Security Configuration
- Physical Security
Once onboard, 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)
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 AWS, Microsoft 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.