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Pass inspections every time

Infrastructure built for consistent compliance

We manage your SQL servers, Active Directory, and infrastructure with the validation documentation that the FDA expects.

Zero failed audits for validated systems
Senior DBAs and System Engineers manage your systems 24/7
Complete IQ documentation from day one

Speak with a regulated IT expert

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Turn your infrastructure into a compliance asset, not a liability

Your SQL servers, Active Directory, and systems get managed by engineers who handle both the technical performance and the compliance documentation. Simultaneously.

infra --managed.log5 entries
$oet infra --managed --what-you-get
Infrastructure managed by senior engineers who understand both technology and GxP requirements
Complete validation documentation maintained continuously, not scrambled together before audits
Performance optimization and compliance management handled together, not as separate tasks
24/7 monitoring with incident response that maintains your validated state
Change control procedures executed correctly, with full audit trails for every modification
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5 items · 5 included · 0 add-onssenior US-based engineers

Infrastructure management services

We deliver specialized infrastructure management designed specifically for regulated environments.

oet infra --listinspection-ready
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spec
service
complianceFDA 21 CFR Part 11 · HIPAA · ITAR · FISMA
methodologyGAMP 5 · CSV with IQ documentation
coverageSQL Server · Active Directory · Windows Server
teamSenior DBAs and system engineers, 24/7

Why companies in regulated industries choose Outer Edge

We specialize exclusively in compliance-critical environments where infrastructure failures have serious consequences.

Specialized in compliance-critical environments

Pharmaceutical manufacturers, medical device companies, biotech research facilities

Computer system validation expertise

GAMP 5 guidelines, 21 CFR Part 11, data integrity requirements

Proven FDA audit success

Engineers with validated system implementations and successful inspection outcomes

Infrastructure failures have real consequences

We understand FDA warning letters, product recalls, operational shutdowns

Senior-level expertise without full-time costs

Database Administrators and System Engineers as extension of your team

20+

Years serving regulated industries

We are not a generalist MSP learning FDA requirements on the fly. Pharmaceutical, medical device, biotech, and regulated manufacturing are where we have always worked.

oet compliance --statusall controls verified
5 controls · 5 verified · 0 exceptions21 CFR Part 11 experience built in

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

Please enter the details below and submit form