01
Digitized work instructions
Replace PDF SOPs with interactive, step-by-step guidance — accessible from any device on the shop floor, with revision tracking and signature capture.
Operational learning for biotech
Train teams to competency.
Meet compliance.
At the speed of biotech.
The platform that 3,093 operators at Pall and 2,804 at Cytiva use to digitize work instructions, run knowledge checks, and prove GMP-grade training — without paperwork.
- ✓ 21 CFR Part 11 & EU Annex 11 aligned
- ✓ Single-tenant or multi-tenant deployment
- ✓ EU data residency · AWS eu-west-1
Built with global biotech leaders
PALL
The platform
One system. Every level of the operation.
02
Train to competency
Build training paths per role. Deliver them with quizzes and AR-enabled simulations. Lock work permissions until competency is proven.
03
GMP-audit trail
Every action — read, completed, signed, deviated — captured with timestamp and user identity. Pull an inspector-ready report in seconds.
04
AR & immersive media
Anchor 3D models to real equipment. Trainees see the right valve, the right torque, the right sequence — overlaid on the physical world.
05
Knowledge management
SOPs, compendiums, training courses, knowledge checks — one structured repository, versioned, searchable, multilingual.
06
Open by design
API-first. Integrates with your QMS, MES, LMS, IdP. Cognito-based SSO. EU data residency on AWS eu-west-1.
Industry & process
Designed against real biotech operations.
Vivarlex isn't a horizontal LMS bolted onto biotech. Every screen, every audit event, every AR scene is shaped by the unit ops your operators actually run — from seed train through fill/finish, on the floor, in the cleanroom, on the equipment.
Inside the bioreactor
Procedures wired to the specific equipment in your plant — every probe, every valve, every torque value. Training data follows the asset, not a generic template.
On the floor
An operator opens the SOP on a tablet. AR anchors the step to the equipment in front of them. Signature + audit log fire on completion. No paper. No deviation.
Across the cleanroom
One deployment covers your ISO 7 / ISO 8 zoning, multiple bioreactors, and shared equipment. Roles map to physical zones, competency gates honor cleanroom flow.
Operations dashboard
See the whole plant in one view.
Competency by site, by role, by line. Compliance scores trending. Audit-ready in one click. The data your auditor wants — without the spreadsheet drudgery.
- Realtime competency status across 24 sites
- Drill from KPI → operator → individual signed SOP
- Configurable alerts for expired training
- Export-ready audit packets (PDF + CSV + JSON)
6,109operators trained on platform
6global biotech orgs in production
99.95%availability target — multi-AZ AWS
21+ TBtraining content delivered
How it works
From scattered PDFs to audit-ready in 6 weeks.
Map & ingest
We start with your existing SOPs, training matrix, and equipment inventory. Our content team turns 200-page PDFs into interactive, role-scoped procedures.
Week 1–2
Train & verify
Operators move through training paths on tablet, phone, AR headset, or PC. Knowledge checks gate next-step assignment. Trainers approve via signature.
Week 3–4
Audit & iterate
You pull GMP-grade reports on demand. Competency matrix updates in real time. Deviation patterns surface so you can fix root causes, not symptoms.
Week 5–6
AR scene editor
Author once. Deliver to iOS, HoloLens and Quest.
Drop a 3D model on your bioreactor, annotate the steps, record voiceover. Vivarlex compiles to every major AR runtime — your operators see the same training overlay, whatever device they happen to grab.
- USDZ & glTF import · plant CAD / LiDAR scan supported
- Multi-collaborator editing with version history
- Localization built in — 14 languages live in production
Built for
Every step of the biotech operation.
Bioprocessing
Bioreactor inoculation, fed-batch operations, single-use system assembly. Tightly-controlled critical-step training.
Fill & finish
Aseptic technique, isolator interventions, smoke studies. AR-guided gowning. Microbiological-grade audit trail.
Cell & gene therapy
Chain-of-custody competency for autologous workflows. Donor-to-patient procedural integrity, certified per batch.
Quality & validation
IQ/OQ/PQ procedure capture. CAPA training assignment. Inspection-ready evidence in a download.
Engineering & MRO
Equipment-specific procedural training. Predictive-maintenance integration. Tribal knowledge captured before it walks out the door.
R&D / Process dev
Capture experimental protocols once, train scale-up teams reliably. Bridge the lab-to-plant gap.
"We replaced eight independent SOP binders, three LMS instances, and an entirely separate audit spreadsheet. The first inspection went from a 6-week scramble to a 3-day walk-through."
Open by design
Plays well with your stack.
REST + GraphQL APIs, webhooks for every domain event, SAML and OIDC SSO, configurable JWT scopes. We've integrated with Veeva, MasterControl, TrackWise, Workday, Okta, Azure AD, ServiceNow, and a dozen home-grown QMS systems.
QMS·MES·LMS·HRIS·ERP·SAML 2.0·OIDC·SCIM·Webhooks·S3 events·CloudTrail
Services
We don't just sell software.
Our content team digitizes your SOPs, builds AR scenes against your real equipment, and delivers training that passes a GMP audit on day one.
Content authoring
Storyboard, illustration, 3D modeling, voiceover. We do it — to your spec, in your language.
AR scene production
From plant CAD or laser scan to deployed AR training in weeks, not quarters.
Validation support
IQ/OQ/PQ artifacts, audit-trail walkthroughs, GAMP 5 alignment with your CSV team.
Onboarding & rollout
Train the trainers, change-management playbook, KPI dashboards, hyper-care for the first 90 days.
Pricing
Transparent. By the operator.
No per-seat surprise bills. No feature gating on compliance. Pick the plan that matches your operation, scale by operator headcount.
Site
€9/op · month
Single plant, up to 200 operators. Self-serve onboarding.
- Full platform
- Audit trail · 7-year retention
- Community support
- EU data residency
Network
€18/op · month
Multi-site, 500-5,000 operators. White-glove onboarding.
- Everything in Site
- Multi-tenant role hierarchy
- SSO via SAML/OIDC
- Dedicated CSM
- 99.95% SLA
Enterprise
Tailored
Custom deployment, dedicated single-tenant AWS account, custom validation.
- Single-tenant infra · your VPC
- Custom audit-trail integration
- 24/7 incident response
- Co-developed roadmap
- BAA / DPA negotiated
Compliance
GMP-grade infrastructure, day one.
- 21 CFR Part 11 & EU Annex 11 aligned audit trail
- GAMP 5 categorized as a Category 4 configurable system
- Single sign-on via Cognito (SAML/OIDC supported)
- Encrypted at rest (KMS) and in transit (TLS 1.2+)
- Daily snapshots, cross-region disaster recovery
- EU data residency on AWS (eu-west-1)
SOC 2-aligned
Hardened on AWS following the Well-Architected Security pillar.
ISO 27001-ready
Asset inventory, access controls, incident response — documented.
Auditable by design
Every user action lands in CloudTrail + the application audit log.
FAQ
What teams ask before they sign.
How long does deployment actually take?
Self-serve onboarding for a single site is live in a week. Multi-site rollouts with dedicated content authoring take 4–8 weeks depending on SOP volume. Our biggest deployment (2,800 operators) went live in 7 weeks.
Will this work with our existing LMS / QMS / MES?
Yes. We're API-first with webhooks for every domain event. Native connectors exist for Veeva Vault QMS, MasterControl, TrackWise, ServiceNow GRC, Workday Learning, and SAP S/4. For anything custom, our REST and GraphQL APIs are public and idiomatic.
Is our data going to be safe?
EU data residency on AWS eu-west-1. KMS encryption at rest, TLS 1.2+ in transit. Daily encrypted snapshots, cross-region DR. Network isolated per tenant via private subnets and Cognito-backed JWT auth. SOC 2 controls audited annually.
Do you support AR hardware we don't own yet?
Yes — every scene exports to iOS / iPadOS, HoloLens 2, Meta Quest 2/3 and Pro, and the web (WebXR). You can start on iPads your operators already carry, then upgrade hardware without re-authoring content.
What does an audit look like with Vivarlex?
The auditor asks for evidence of operator X being trained on SOP Y as of date Z. You filter the audit-trail view, click export, and hand them a tamper-evident PDF + JSON pack in under 60 seconds. We've shipped this through FDA, EMA, ANVISA, and Swissmedic inspections.
What does the platform cost on the back end (AWS)?
Pricing above is all-in — you don't pay AWS separately. We run on AWS but absorb the infra cost. The model is built around per-operator/month, not per-GB or per-API-call.
Ready to see what your training data looks like?
Send us your hardest SOP. We'll digitize it and show you the training experience in less than a week.
hello@vivarlex.comNo pitch deck. No 5-call discovery. We come to your plant, watch your operators, write the demo around what actually matters.