GxP-aligned cloud hosting on dedicated single-tenant infrastructure for pharma, biotech, medical device and CRO teams across New Jersey's pharmaceutical corridor. 21 CFR Part 11 audit trails, documented change control, and an engineer who has been through an inspection before. The infrastructure side of validation handled, so your quality team can focus on the science.
Most life sciences IT problems are not exotic. They are four operational realities, made non-negotiable by FDA and EMA exposure. Here is what we hear from IT and quality leaders in this space.
Every infrastructure change to a GxP system means impact assessment, IQ/OQ evidence and a change record. When the hosting layer changes under you without notice, the validated state is gone and the paperwork starts over.
An FDA 483 observation on data integrity can trace straight back to missing audit trails or uncontrolled admin access at the infrastructure layer. Evidence has to exist before the inspector asks, not be reconstructed after.
ALCOA+ expectations for attributable, contemporaneous and enduring records are hard to defend on shared public cloud where you cannot see who else touches the physical host or the hypervisor change log.
LIMS, ELN, QMS and chromatography data systems run on servers that were due for refresh two cycles ago. Revalidating on new hardware is expensive, so the refresh keeps slipping and the risk keeps growing.
Your validated systems on your hardware. No shared tenancy, no undocumented neighbor activity, and a hypervisor change log your quality unit can read.
Every administrative action, data access and configuration change logged centrally with tamper-evident retention, attributable to a named account. Evidence is a search query, not a project.
Infrastructure changes are scheduled, documented and communicated in advance so your impact assessment and revalidation scope stay predictable. No surprise patches to a validated environment.
Environment descriptions, configuration baselines and control documentation that plug into your IQ/OQ packages. We supply the infrastructure evidence; you keep ownership of the validation.
Laboratory informatics, quality management and chromatography data systems run on our infrastructure today, with runbooks for the vendors that require named-host licensing.
Three IT Vortex services that map most directly to validated environments, data integrity expectations and the cost of a lab going dark.
Single-tenant dedicated infrastructure with documented change control. The cleanest validation scope and the fewest quality-unit objections. The right answer for GxP systems and regulated data.
Explore Private CloudFully operated infrastructure with inspection-ready documentation and continuous security posture management. The right answer for IT teams that cannot staff 24/7 operations alongside validation work.
Explore Managed CloudReplicated, tested recovery for LIMS, ELN and manufacturing execution systems, with documented RTO and RPO your quality unit can cite. The right answer when a lab outage means lost batches.
Explore DRaaSA multi-billion-dollar multinational corporation executed a flawless headquarters relocation on IT Vortex cloud hosting, with zero downtime and zero disruption to global operations.
Validation belongs to the regulated company, not the hosting provider, and no reputable provider should tell you otherwise. What we provide is a qualified, documented infrastructure layer: configuration baselines, change control records, access and audit logs, and environment descriptions that drop into your IQ/OQ packages. Your quality unit keeps ownership of the validated state; we keep the infrastructure from changing underneath it.
At the infrastructure layer Part 11 comes down to attributable access, tamper-evident audit trails, time-stamped records and controlled change. Every administrative action and data access on your environment is logged centrally with retention you set, named accounts with MFA, and a change process that produces a record before the change happens. Application-level Part 11 controls, such as electronic signatures inside your LIMS, stay with the application vendor.
Nothing changes without a scheduled, documented change that you have seen in advance. Routine patching follows a published calendar so your impact assessments are predictable, emergency security changes are communicated with the evidence your change board needs, and every change is logged. Validated environments are never auto-updated.
Yes. Laboratory informatics, quality management and chromatography data systems from the major vendors run on our infrastructure today, including the ones that need named-host or hardware-bound licensing. We coordinate with your application vendor on supported configurations and escalation paths.
All infrastructure is located in U.S. datacenters, and we document the specific datacenter location and operational jurisdiction for your inspection binder. Cross-border data residency is not something we currently support.
We will come back with a tailored cloud assessment and proposed architecture within one business day.
One business day response. No obligation.
Fill out the form below and our hiring team will reach out to you as soon as possible
We use Zoom extensively to meet internally and externally. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Wasabi is offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Our Datacenter is built on a VMWare architecture. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Veeam is offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Solarwinds is offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Proofpoint Essentials is offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Proofpoint Insider Threat Management (formerly ObserveIT) is offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
We use NEAT extensively in our offices. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Our telephone platform of choice. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Various Microsoft technologies are offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Our distribution preferred partner for our technology offerings.
The Fortinet Security Fabric is offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
We use DTEN extensively in our offices. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Dell servers are a key component offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Condusiv Technology is offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Cisco Technology is offered in our Cloud Hosting Platform via DUO for MFA. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
Barracuda Technology is offered in our Cloud Hosting Platform. We are Certified Reseller, we have Certified Implementation Experts on staff, we provide architecture advisory services for a robust implementation.
IT Vortex runs managed AWS workloads alongside its VCF private cloud, so hybrid designs keep one operations team and one set of runbooks.
Technology Reseller and Distributor, Certified Implementation Expertise with all ACTi products and services. IT Vortex has worked with ACTi for over a decade implementing security camera solutions for a multitude of industries with AI, Facial Recognition, License Plate Recognition, Loitering Detection, Cloud storage, and more.
Request a free consultation. Fill out the form and we will call you to answer all your questions
IT Vortex integrates Microsoft 365 and Microsoft Entra ID across our cloud platform—enabling seamless SSO, identity governance, and hybrid connectivity between on-premises and cloud workloads.
Choose a service, answer a few simple questions, and receive an individual quote for our services
Fill out the form and we will call you to answer all your questions
Fill out the form and we will call you to answer all your questions
