QWise Docs
Control, version, distribute and retire every regulated document — with cryptographic integrity from creation to retirement.
- Lifecycle workflows & e-signatures
- Controlled-copy & periodic review
- PDF/A long-term archival
QWise is the next-generation Electronic Document Management System built for regulated industries — engineered for audit-readiness, designed for the people who run quality every day.
Six purpose-built modules sharing one audit-grade core. Start with what you need today; extend without re-integration tomorrow.
Control, version, distribute and retire every regulated document — with cryptographic integrity from creation to retirement.
Run CAPA, deviation, change-control and risk processes on configurable workflows — no consultants, no code.
Train, qualify and re-qualify your workforce — and prove competence the moment an inspector asks.
Plan, execute and close internal, supplier and regulatory audits — with inspector-mode read-only access.
Real-time dashboards over your entire quality ecosystem — so you act before the next CAPA, not after.
Advisory intelligence that surfaces drift, anomalies and overdue actions — always governed under Annex 22.
QWise gives you real-time visibility across your quality ecosystem — so you can act faster, reduce risk, and walk into any audit with confidence.
Most quality systems make compliance a tax on your day. We rebuilt the foundation so that doing the right thing is also the fastest thing.
Tamper-evident audit chains, hardware-grade signatures and WORM-anchored archives are part of the core — not features you bolt on.
Bulk actions, smart approval routing and AI-assisted authoring reclaim the time your team currently spends fighting the system.
Inspector mode delivers a time-boxed, read-only view of every record and signature — no preparation marathon required.
Documents, quality, training, audits, analytics and AI on a single tenancy — one identity, one audit trail, one source of truth.
Workflows, fields and templates configured by your quality team — no consultants, no professional-services lock-in.
Region-locked data, tenant-scoped encryption keys and a privacy module designed around GDPR — without giving up GMP retention.
Wherever a regulator can walk through your door, QWise gives you the answer before they ask.
GMP-grade document control, signature chains and inspector mode for FDA, EMA, MHRA, EDA, SFDA and PIC/S audits.
Lifecycle controls for cell & gene therapy programs, biologics manufacturing and translational research.
ISO 13485 design history files, UDI traceability and electronic records aligned with EU MDR & FDA QSR.
HACCP, FSSC 22000 and BRCGS-aligned document and training control with full lot & supplier traceability.
ISO 22716 compliance, formulation control and PIF readiness for both EU and rest-of-world markets.
Quality agreements, supplier qualification, and multi-tenant separation for CDMOs and CMOs.
Multi-Site Operations
One QWise tenant runs every manufacturing site — each with its own folders, workflows, approver pools, and audit trail. No site can see, edit, or even discover another site's documents. Cross-site escalations are explicit, never silent.
Each site has its own folder tree of SOPs, work instructions, specifications, and forms. Users only see the sites they're assigned to.
Every role grant carries a site identifier. Cross-site queries are rejected at the data tier — not just hidden in the UI.
Reviewer pools, QA Approver groups, and Doc Controllers are configured per site, so each site's documents are signed off by the people accountable for that site.
When a site's reviewer pool is exhausted, escalation to a sister site requires documented justification, dual signatures, and an audit entry that names both sites.
Every export, every Inspector session, every periodic-review report is scoped to one site — auditors see exactly what they need, nothing else.
One customer equals one tenant with a dedicated schema. Cross-tenant access is structurally impossible at the database role level.
Regulatory alignment EU GMP Annex 11 §7 & §12 (Access Control & Security) · PIC/S PI 041 §10.2 (Least-Privilege RBAC) · 21 CFR §11.10(d) (Limited access to authorized individuals) · ICH Q10 (Site-distinct quality systems)
Every action in QWise is bound to an identity, sealed with a hash, and chained to the one before it. Tamper any record and the chain tells you which one, when, and by whom.
Faster document cycle times after migration to QWise.
First-time audit pass rate across QWise pilot tenants.
Of regulated events captured in tamper-evident audit chains.
Region-locked operations with 99.95% availability SLA.
Our delivery model is designed around your quality team's reality, not a vendor playbook.
We map your current QMS, document inventory and audit history. You get a URS workbook and a pre-validation gap report — yours to keep.
Your team configures workflows, fields and templates in QWise Studio. We coach. No bespoke development, no version lock-in.
Legacy documents migrated with attestation: every record gets a hash, a provenance record and a reconciliation report.
IQ/OQ/PQ executed against your URS. Sign-off pack handed over. From day one you can walk an inspector through the system.
Book a 30-minute walkthrough with our quality & engineering team. We'll show you QWise running against a regulated workload — and answer the hard questions before you ever sign anything.