Validated by architecture,
not by promise.
Other vendors bolt compliance on top of generic systems. V5 Cloud bakes it into the persistence layer — audit trails fire from database triggers, RLS enforces isolation, and signatures capture an immutable snapshot at the moment of signing.
How V5 Cloud delivers defensible compliance
21 CFR Part 11 E-Signatures
Re-authentication, meaning of signature, immutable record snapshot, and signed manifest hash on every controlled action.
Immutable Audit Trail
Every create / update / delete captured at the database tier. Append-only — no application code can rewrite history.
Tenant & Role Isolation
Postgres row-level security enforces tenant boundaries and role permissions on every query — not in app code.
Validated Cloud Infrastructure
IQ/OQ/PQ documentation supplied per release. SOC 2 controls, encrypted at rest and in transit, regional data residency.
Every regulator. Every record.
FDA Electronic Records & Signatures
Authentication controls, audit trails, time-stamped signatures, system documentation — all native.
FDA cGMP for Pharmaceuticals
Master batch records, deviation control, change control, supplier management.
FDA QSR for Medical Devices
Design controls, eDHR, complaint handling, CAPA — aligned with ISO 13485.
Medical Device Quality Systems
Risk-based document control, training records, supplier scorecards.
FDA Food Traceability Final Rule
Critical Tracking Events (CTE) and Key Data Elements (KDE) capture and export.
Global Food Safety
Pre-op checks, sanitation, allergen segregation, mock recall workflows.
EU GMP — Computerised Systems
Validation, change management, electronic records aligned with EMA expectations.
Modernization of Cosmetics Regulation
Facility registration, product listing, adverse event reporting workflows.
Meat & Poultry Inspection
Pre-shipment review, label approval workflows, lot-level traceability.
IQ/OQ/PQ documentation, included with every release.
We supply Installation Qualification, Operational Qualification, and Performance Qualification protocols — pre-executed for the cloud environment, ready for your QA to attach to your validation file.
- URS / FRS / DS templates
- Risk assessment (GAMP 5 categorized)
- Pre-executed IQ for the V5 Cloud environment
- OQ scripts mapped to functional requirements
- PQ runbook for customer validation
- Release notes with regulatory impact assessment
CREATE TRIGGER trg_audit_items
AFTER INSERT OR UPDATE OR DELETE
ON public.items
FOR EACH ROW
EXECUTE FUNCTION fn_audit();
-- captures: who, when, before, after,
-- changed_fields, reason,
-- ip, user_agent
--
-- INSERT-only RLS. No UPDATE.
-- No DELETE. Ever.