99 %+
OTIFlast 90 days
Quality & Compliance
Quality is our operating system
- GDP-Aligned QMS across packaging, storage, distribution, and shipping
- Audit-Ready Records: photos, traces, custody, release notes and a Shipment Passport per shipment
- Unified visibility: Control Tower for warehouse activity, inventory, orders, and in-transit status (with Status & Uptime)
- Compliance gating: validated pack-outs and international/interstate documents checked before release
How We Do It
How We Ensure Quality
Define the profile
Design the plan
Packaging Strategy
Monitoring + evidence capture
Execute + manage exceptions
Closeout documentation
Operate & Improve
QMS in Practice
SOPs & Roles
Training & Competency
Deviation → RCA → CAPA
Document Control & Retention
Vendor Qualification
Data Integrity
Our experience
Quality Metrics & Governance
- Quality: release & CAPA ownership
- Operations: warehouse execution, pack-outs, comms SLAs, carrier hand-offs
- Security: data & access controls; privacy & retention
100 %
1 %
Straight answers on shipping, packaging, and storage
Frequently Asked Questions
If you don’t see your scenario, contact us and we’ll map your lane.
01
How do you ensure temperature compliance in transit?
01
How do you ensure temperature compliance in transit?We design lanes from the risk backward: qualified pack-outs, correct PCM phase/quantity, and dual-point logging (payload + wall). Streaming is available for long or volatile lanes. Control Tower monitors milestones and alerts on risk, and every order generates a Shipment Passport with build photos, custody scans, and the temperature trace.
02
What packaging should we use for 2–8 °C, CRT, or frozen shipments?
02
What packaging should we use for 2–8 °C, CRT, or frozen shipments?We match packaging to lane duration and ambient volatility—mailers/liners for short mild lanes, rigid shippers for medium routes, and VIP/PUR for long or extreme conditions. We specify PCM phase & quantity and provide a conditioning SOP with photos.
03
Can you pre-clear international shipments?
03
Can you pre-clear international shipments?Yes. We align commodity descriptions/HTS, permits, and labeling before dispatch and brief the broker, reducing arrival holds.
04
What is the Shipment Passport and what does it include?
04
What is the Shipment Passport and what does it include?It is a digital, shareable audit packet attached to every order—chain of custody, conditioning logs, logger IDs and traces, milestones, and any deviations/CAPA. RA/QA can release faster with a single source of proof.
05
Do you support streaming loggers as well as PDF devices?
05
Do you support streaming loggers as well as PDF devices?Yes. We support both. Streaming enables proactive saves on longer/volatile lanes; PDFs are acceptable for short, stable routes. Either way, we time-sync devices and place sensors to capture product truth (payload) and enclosure behavior (wall).
06
How do Direct-to-Patient (DtP) deliveries handle identity and custody?
06
How do Direct-to-Patient (DtP) deliveries handle identity and custody?We follow a repeatable handoff script: identity verification, temperature/indicator check, scan/signature, and clear instructions. Returns include monitored kits and custody scans for reconciliation.
07
Do you provide GDP storage and distribution? What environments and SLAs?
07
Do you provide GDP storage and distribution? What environments and SLAs?Yes—2–8 °C, CRT, and frozen/deep-frozen. We publish pick/pack SLAs, cut-off times, and temperature compliance KPIs.
08
What happens if there’s an excursion or deviation?
08
What happens if there’s an excursion or deviation?We alert, execute the approved save plan if possible, and document actions in Control Tower. Deviations trigger CAPA within our GDP-aligned QMS. The Passport records the trace and outcome for inspection.
09
How do you protect data, PHI, and uptime?
09
How do you protect data, PHI, and uptime?Minimum-necessary data model with role-based access, encryption in transit/at rest, audit logging, and vendor risk management. We publish 90-day uptime and incident notes.
10
How do we get a quote and how fast is onboarding?
10
How do we get a quote and how fast is onboarding?Use request a quote for shipping, packaging, or storage. Onboarding typically includes lane mapping, packaging selection, and site SOP alignment—often within a few business days depending on scope.

