OBS Pharma
All-in-One
GMP, LIMS & ELN Platform
Streamline compliance, unify labs, and accelerate production—designed for modern pharma.
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Key Challenges We Solve
Mounting Regulatory Pressure
GxP, EU Annex 11, FDA, GDPR—ensuring compliance is no small task in a dynamic environment.
78% of pharma companies struggle with regulatory changes
Our platform automatically adapts to regulatory updates, ensuring you're always compliant.
Disconnected Systems & Data Silos
Fragmented lab results, production records, and QA processes hinder traceability and collaboration.
65% time savings with unified data systems
Our platform connects all your systems into one seamless interface, eliminating data silos.
Paper-Heavy, Error-Prone Processes
Manual paper logs cause delays and increase errors during reviews and approvals.
Reduce documentation errors by up to 92%
Digital workflows eliminate transcription errors and accelerate review cycles.
Unstructured Training & Qualifications
Without a central system, managing critical task qualifications becomes chaotic.
40% reduction in training administration time
Automated qualification tracking ensures only trained personnel perform critical tasks.
Slow Batch Release & Audits
Manual data reconciliation postpones batch releases and complicates audits.
Reduce batch release time by up to 70%
Real-time data aggregation makes batch review and audits dramatically faster.
Maintaining Data Integrity & Security
Protecting sensitive information and ensuring tamper-proof records is vital.
100% compliant with 21 CFR Part 11
Built-in audit trails, e-signatures, and encryption protect your critical data.
Our Modular Pharma Platform
Choose the modules you need and integrate them to build a solution as deep as your requirements.
GMP Suite
Effortless quality & compliance.
Deviations
Structured oversight
- Risk-based classification
- Root cause analysis
- Regulatory traceability
CAPA
Proactive resolution
- Corrective measures
- Effectiveness review
- Audit readiness
Change Control
Risk-based evaluation
- Role-based approvals
- Impact assessment
- Automated alerts
Document Management
Control & traceability
- Version control
- Approval workflow
- Compliance logging
Training & Qualification
Ensuring readiness
- Automated tracking
- Certification control
- Audit records
Batch Records
Digital & compliant
- Auto data capture
- Smart approvals
- Secure e-signatures
Supplier Qualification
Only the best
- Supplier audits
- Risk-based assessments
- Ongoing monitoring
Complaints & Recall
Swift resolution
- Complaint tracking
- Targeted recalls
- Regulatory compliance
LIMS Suite
All lab data in one place.
Specification Manager
Centralized test specs
- Predefined methods
- Acceptance criteria
- CoA generation
Instrument Management
Calibration & maintenance
- Automated schedules
- Usage history
- Regulatory tracking
Stability Management
Quality over time
- Structured testing
- Storage tracking
- ICH compliance
Inventory Management
Always in stock
- Material tracking
- Expiry alerts
- Full traceability
Environmental Monitoring
Controlled lab conditions
- Sampling schedules
- Accurate logging
- Annex 1 compliance
Electronic Lab Notebook (ELN)
Step‑by‑step lab control.
Procedure Breakdown
Detailed steps
- Consistent actions
- Step-by-step recording
- Improved reproducibility
Structured Data Capture
Real-time logging
- Manual & instrument data
- Complete traceability
- Easy audit trails
Control History
Audit trail at a glance
- All changes logged
- Automated backups
- Full visibility
Real‑Time Results
Instant updates
- Shared data
- Faster decisions
- Enhanced oversight
Hardware Integration
Seamless instrument connectivity.
Automated Data Capture
Direct instrument input
- Eliminates manual errors
- Faster data flow
- Consistent results
Minimized Manual Entry
Efficiency boosted
- Streamlines workflows
- Reduces duplications
- Saves time
Real‑Time Integration
Full system sync
- Instant data sharing
- Accurate records
- Regulatory compliance
What Our Clients Say
Real experiences from real users.
Connect to Everything You Need
Seamless connectivity with your existing systems.
API-First Approach
Flexible integration
- Link with ERP systems
- Connect to HCM platforms
- Minimal IT overhead
SSO & Role-Based Access
Secure authentication
- Microsoft integration
- Streamlined user management
- Granular permissions
File Servers & Repositories
Document management
- Automated imports/exports
- Scheduled backups
- Cloud system support
Lab Equipment Integration
Direct data capture
- Immediate data transfer
- Reduced manual entry
- Error prevention
Frequently Asked Questions
Common questions about our platform.
Pricing & Plans
Cost structures, discounts, upgrades
You can subscribe to individual suites or choose a bundled package for maximum cost efficiency. We offer tier-based subscription models with volume discounts for larger organizations.
Yes. We offer tiered pricing for multi-site enterprises and teams on a growth trajectory. The more users you have, the more cost-effective our platform becomes.
Standard support is always included in your subscription. Premium support with faster response times and dedicated account managers is available as an upgrade option.
Features & Modules
Capabilities, integrations, functionality
Our LIMS suite covers instrument management, stability studies, inventory tracking, environmental monitoring, and specification management. Each component is designed to streamline lab operations and ensure compliance.
Each deviation is assigned a severity, tracked for root cause, and linked to CAPA for complete resolution. The system provides risk-based classification, automated workflows, and full regulatory traceability.
Yes, our ELN integrates with most modern lab instruments through our hardware integration module. This allows for direct data capture, eliminating manual entry and reducing transcription errors.
Technical & IT
Deployment, requirements, security
Yes, we offer both deployment options. SaaS hosting is available in secure EU-based data centers, or you can opt for on-premise deployment if you prefer local control over your data and infrastructure.
For on-premise deployments, we recommend servers with at least 16GB RAM, quad-core processors, and SSD storage. Detailed specifications will be provided based on your expected user load and data volume.
Yes, we support SSO integration with Microsoft Azure AD, Okta, and other major identity providers. This streamlines user management and enhances security across your organization.
Compliance & Security
Regulatory standards, data protection, validation
Yes, we comply with 21 CFR Part 11, offering secure e-signatures, full audit trails, and data integrity measures including hashing and encryption to protect data integrity and meet regulatory requirements.
All data is encrypted both in transit and at rest. We implement GDPR-compliant data handling practices, including data minimization, purpose limitation, and the right to be forgotten where applicable.
Yes, our platform is ISO 27001 certified, demonstrating our commitment to information security management. We also maintain compliance with GxP, EU Annex 11, and other relevant regulatory standards.
Onboarding & Support
Implementation, training, ongoing assistance
Implementation timelines vary from 8–16 weeks depending on the complexity of your requirements and the number of modules being implemented. We assign a dedicated project manager to ensure smooth deployment.
Yes, we provide comprehensive data migration services to help you transition from legacy systems. Our team will work with you to map data structures and ensure a clean, validated transfer of your information.
Standard support is available Monday–Friday, 8 AM–6 PM (local time). Premium support with 24/7 coverage is available for critical issues and production environments that require continuous monitoring.
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