All-in-One GMP, LIMS & ELN Platform
Streamline compliance, unify labs, and accelerate production — designed for modern pharma.
Key Challenges We Solve
Six problems every pharma team knows — and how VitaOS addresses them.
Mounting Regulatory Pressure
GxP, EU Annex 11, FDA 21 CFR Part 11 — every update demands documentation changes, re-training, and process reviews. Most teams manage this manually, across spreadsheets and email threads.
Disconnected Systems & Data Silos
Lab results in one system, deviations in another, documents in a third. When something goes wrong, tracing the full picture takes hours — or days.
Paper-Heavy, Error-Prone Processes
Paper batch records, handwritten temperature logs, printed SOPs with handwritten signatures. Every manual step is a transcription risk and an audit liability.
Unstructured Training & Qualifications
Someone performs a critical task they are not yet qualified for. It happens in busy labs. The qualification records are in a spreadsheet no one checks before assigning work.
Slow Batch Release & Audits
QP release requires gathering data from multiple systems, chasing signatures, and reconciling paper records. A process that should take hours takes days.
Maintaining Data Integrity & Security
Regulators expect immutable records, traceable changes, and access control. Building this on top of a generic system means constant validation work.
Quality processes,
end to end
From deviation capture to CAPA closure — every quality event tracked, linked, and audit-ready. No email threads, no spreadsheets.
See the full quality loop →Deviations
- Risk-based classification
- Root cause analysis
- Regulatory traceability
CAPA
- Corrective measures
- Effectiveness review
- Audit readiness
Change Control
- Role-based approvals
- Impact assessment
- Automated alerts
Document Management
- Version control
- Approval workflow
- Compliance logging
Training & Qualification
- Automated tracking
- Certification control
- Audit records
Batch Records
- Auto data capture
- Smart approvals
- Secure e-signatures
QP Certification
- Auto-generated checklist
- E-signature & register
- PDF batch certificate
Supplier Qualification
- Supplier audits
- Risk-based assessments
- Ongoing monitoring
Complaints & Recall
- Complaint tracking
- Targeted recalls
- Regulatory compliance
Register Management
- Any register, digitized
- Audit trail on every entry
- Clean data, search & filters
Audit Management
- Internal, supplier, inspection
- Predefined checklists
- Closes with its actions
Лабораторията,
организирана
Спецификации, изпитвания, апаратура, стабилност — в един модул. Резултатите директно захранват отклоненията и CoA.
See how LIMS works in a real lab →Specification Manager
- Predefined methods
- Acceptance criteria
- CoA generation
Instrument Management
- Automated schedules
- Usage history
- Regulatory tracking
Stability Management
- Structured testing
- Storage tracking
- ICH compliance
Inventory Management
- Material tracking
- Expiry alerts
- Full traceability
Environmental Monitoring
- Sampling schedules
- Accurate logging
- Annex 1 compliance
Всеки експеримент,
записан точно
Пълна разбивка на стъпки, параметри и изчисления. Суровите данни от апаратурата директно в записа — без ръчно прекопиране.
See how experiments get recorded →Procedure Breakdown
- Consistent actions
- Step-by-step recording
- Improved reproducibility
Structured Data Capture
- Manual & instrument data
- Complete traceability
- Easy audit trails
Control History
- All changes logged
- Automated backups
- Full visibility
Real-Time Results
- Shared data
- Faster decisions
- Enhanced oversight
Апаратите говорят
директно
Данните от HPLC, pH метри, спектрофотометри и термостати влизат директно в ELN записа. Без ръчно прекопиране, без транскрипционни грешки.
See direct instrument connectivity →Automated Data Capture
- Eliminates manual errors
- Faster data flow
- Consistent results
Minimized Manual Entry
- Streamlines workflows
- Reduces duplications
- Saves time
Real-Time Integration
- Instant data sharing
- Accurate records
- Regulatory compliance
Validation, without starting from a blank page
A structured documentation package, IQ/OQ/PQ protocols and hands-on support at every stage — so your team validates faster and audits go smoother. The final decision for GxP use stays with you.
Select a document to see what we provide.
Template and support for defining strategy, scope, roles and criteria.
Used at stageURSTemplate, workshops and help formulating your requirements.
Used at stageURSDescription of the system functionality.
Used at stageURSMaintainDocumentation of the configuration and architecture.
Used at stageIQMaintainMethodology and support for assessing GxP risks.
Used at stageRiskLinks requirements, risks and tests.
Used at stageRiskMaintainInstallation checks, evidence and results.
Used at stageIQFunctional tests and documented results.
Used at stageOQScenarios for your own processes, with support during execution.
Used at stagePQSummary of results, deviations and residual risks.
Used at stageReportProcedures for access, changes, archiving, backup and incident management.
Used at stageGo-liveDocumentation on development, testing, versions, quality and maintenance.
Used at stageRisk
Adapted to your system version and configuration. Some documents we draft end to end; others — such as your URS, risk assessment and PQ — need your input and approval.
User Requirements (URS)
Everything starts with what you need the system to do.
Templates, workshops and help formulating your requirements.
Define and approve the requirements.
- VPValidation Plan
- URSUser Requirements
- FSFunctional Specification
Risk Assessment (RA)
Validation effort goes where GxP risk is highest.
Methodology and guidance for the GxP risk assessment.
Assess and approve the risks.
- RARisk Assessment
- RTMTraceability Matrix
- SUPSupplier Documentation
Installation Qualification (IQ)
Proves the system is installed and configured correctly in the agreed environment.
Prepare the protocol and can execute the tests.
Review and approve.
- DSConfiguration & Design
- IQProtocol & Report
Operational Qualification (OQ)
Proves the system works as specified — access rights, audit trail, e-signatures, workflows.
Prepare the protocol and execute the agreed tests.
Review, witness where needed, and approve.
- OQProtocol & Report
Performance Qualification (PQ)
Proves the system reliably supports your real processes.
Prepare the scenarios and assist with execution.
Execute or oversee execution, and approve.
- PQProtocol & Report
Validation Summary Report
Results, deviations and residual risks in one document.
Prepare the draft report.
Approve the final conclusion.
- VSRValidation Summary Report
Go-live
The moment the system moves into regulated use.
Provide technical readiness.
Authorize production GxP use.
- SOPSOP Templates
Maintaining the validated state
Every release gets an impact assessment — not every update means full re-validation.
Release notes, change impact assessment, regression test evidence, an updated traceability matrix and audit support.
Approve the impact assessment and the scope of any re-validation.
- FSFunctional Specification
- DSConfiguration & Design
- RTMTraceability Matrix
Final responsibility for showing the system is fit for its GxP use stays with the regulated company, in line with EU GMP Annex 11 and GAMP 5. We provide the evidence, the tools and the expertise.
Connect to Everything You Need
Seamless connectivity with your existing systems.
API-First Approach
- Link with ERP systems
- Connect to HCM platforms
- Minimal IT overhead
SSO & Role-Based Access
- Microsoft integration
- Streamlined user management
- Granular permissions
File Servers & Repositories
- Automated imports/exports
- Scheduled backups
- Cloud system support
Lab Equipment Integration
- Immediate data transfer
- Reduced manual entry
- Error prevention
See VitaOS in your lab
VitaOS deploys on your real processes — batches, methods, instruments and training records — and keeps every action audit-ready.
Request a demo presentation