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Cloud ready for today’s regulated environments

For over a decade, Outer Edge has specialized in designing, managing and assisting its clients to validate cloud-based Quality 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.

Compliance frameworks we support

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.

oet compliance --frameworks5 frameworks
21 CFR Part 11 & Part 820
supported
Annex 11
supported
HIPAA
supported
GAMP 5
supported
SOC 2, Type II
supported
validation-readyIQ · OQ documentation

Here are a few of the current life sciences instances within our life sciences portfolio.

We leverage the AWS and Microsoft Azure platforms as well as our own Private Cloud data centers to provide our customers with flexibility.

life-sciences.log9 entries
$oet portfolio --life-sciences
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
$
AWS · Azure · private cloudregulated industries

Ready for compliant, audit-ready infrastructure?

Reduce compliance workload, approach audits with confidence, and free up your team to focus on strategic priorities. Schedule an infrastructure consultation today.

01
Submit the form (or call us at (844) OET-EDGE)
02
We conduct an initial infrastructure and compliance consultation
03
You receive recommended next steps, scope, and timeline
zero surprises. audit-ready from day one.
Prefer to talk now?Call (844) OET-EDGE

Speak with a regulated IT expert

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