Validated Cloud For Life Sciences
Fully Managed Cloud Solutions for a Specialized Industry
For over a decade, Outer Edge has specialized in designing, managing and assisting clients qualify and 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. We also routinely assist our Life Sciences and Pharmaceutical customers satisfy their compliance requirements by providing the evidence and audit trail necessary for their IQ validation process.
Advantages of Working with OET
In the regulated business space, falling behind is not an option. You need partners with experience to keep pace with the expectations of clients, stakeholders and FDA regulators. Not all MSP’s are created equal. When it comes to selecting a cloud service provider, experience and qualifications matter. Outer Edge is “audit ready” – our business practices, procedures and operational controls routinely pass audits without exceptions including the applicable provisions of 21 CFR Part 11, EudraLex Volume 4 – Annex 11, GAMP 5 and ISO:900. Outer Edge should be at the top of your list when it comes to your qualified and validated cloud computing needs.
Life Science Experience
Outer Edge boasts a deep bench of IT subject matter experts who lead the design, implementation, and management of cloud strategies and data recovery solutions and we routinely work with customers to validate regulated IT environments.
With our expertise, we can host the most common applications outlined in the Purdue Model (Enterprise, DMZ, Manufacturing, and Cell/Area zones). These are some examples from our 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
Reliable Validation & Compliance
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
- Security and System Access
- System Access / Delegated Security Configuration
- Physical Security Network
Cloud Infrastructure Designed for Life Sciences
Outer Edge offers multiple IT environment options and partners with world-class vendors to provide the best quality system for your business needs. Beyond our own private cloud offering, we also design and manage environments in AWS, Microsoft Azure, and customer on-premise infrastructures. This way we can seamlessly spin up environments and model out multiple scenarios, helping customers determine which cloud option suits them best.
Once onboard with Outer Edge, 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. This way, the performance and security of your IT networks and infrastructure is ensured even now, in the age of the remote workforce.
Industry-Leading Design & Management
It seems obvious to us, but we often see designs missing one or two of these key components. Our engineers have an average of 20 years of experience, ensuring all facets of your IT environment will be properly considered, designed and implemented.
We follow industry-specific best practices for infrastructure design and management; our audit-ready quality systems are ISO 9001: 2015, CFR Part 11, GAMP 5 complaint, and SOC II certified. Every design includes the critical components necessary in a regulated life sciences environment:
- Security (Network, Storage, Access)
- Redundancy (Hardware, Network)
- Data Retention, Archive, Backup & Recovery
- Latency Optimization (Network, Storage)