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
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What We Do
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.
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
Our Services
Infrastructure Management Services
We deliver specialized infrastructure management designed specifically for regulated environments.
SQL Server Management
Senior DBAs optimize your SQL performance while maintaining validation documentation. Baseline health checks, performance tuning, security reviews, upgrade planning. Fast databases that pass audits.
Active Directory Management
Cloud or hybrid AD with full audit trails. Identity management, FSMO role hosting, replication, ADFS for single sign-on. Secure access control designed for GxP.
System Administration
Windows Server infrastructure management—physical and virtual. Disaster recovery, patching, provisioning, user management. Expert support without full-time hiring costs.
Compliance Infrastructure
Computer System Validation with IQ documentation. Change control procedures. FDA 21 CFR Part 11, HIPAA, ITAR, FISMA alignment. Infrastructure and documentation that passes inspections.
Our Process
How We Deliver Validated Infrastructure
Unlike cookie-cutter implementations, we build validated infrastructure that fits your specific compliance requirements and business operations.
Step 1
Requirements Alignment
Review the software vendor’s infrastructure specifications, conduct a Compliance Impact Assessment, and confirm and scope all requirements.
Step 2
Design & Planning
Develop the infrastructure design and provisioning plan, define the qualification strategy (IQ planning), and ensure the design is reviewed and approved.
Step 3
Build & Prepare
Deploy environments and configure infrastructure, review build decisions and supporting controls, and verify that the build is fully traceable.
Step 4
UAT & Validation
Coordinate User Acceptance Testing (UAT), execute validation protocols, and open the validation test window.
Step 5
Change Control & Final Review
Log updates and manage change control, reconcile evidence and resolve open items, and validate overall go-live readiness.
Step 6
Deployment
Launch and support the infrastructure, complete final review and sign-off, and obtain approval for go-live.
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
15+ Years Serving Regulated Industries
SOC 2 Type II Compliant
ITAR Ready Environments
100% US-Based Engineers
HIPAA Compliant Infrastructure
FDA Validation Experience
