CSV Reinvented: Powering Compliance, Protecting Patients, Driving Growth
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Smarter Compliance, Faster Delivery: AI-Driven CSV & CSA for Pharma 4.0
The future is intelligent Validation
Say goodbye to manual-heavy processes. The next wave is AI-powered CSV/ CSA, designed to:
- Automate Validation tasks
- Reduce errors and costs
- Accelerate audit readiness
- Deliver continuous Compliance at scale
With intelligent accelerators, you don’t just validate, you assure, innovate, and accelerate.
The Compliance crunch
80%
of manufacturers cited by the FDA for Validation gaps
70%
of companies face launch delays due to Validation bottlenecks
$100K
spent validating a single product
50–80%
of failures traced back to documentation & training issues
Our CSV portfolio
Validation-as-a-Service (VaaS)
- IQ/OQ/PQ authoring & execution
- Cloud Validation
- Agile Validation-CI/CD/CT integration with automated regression
Compliance Factory
- SOPs, change control & CAPA
- Deviation handling and closure
- Mock inspections and vendor qualifications
- SDLC documentation & AMS Compliance
Advisory & Strategy
- CSV- CSA Transition frameworks & roadmap design
- Global process harmonization of Validation processes
- Consulting for regulatory office setup
Specialized CSV
- MES, SCADA, PLC, DCS & instrumentation
- Cleaning and sterilization IT Validation
- LIMS, CDS & analytical labs S/w CSV
- Packaging & serialization s/w CSV
Validation-as-a-Service (VaaS)
- IQ/OQ/PQ authoring & execution
- Cloud Validation
- Agile Validation-CI/CD/CT integration with automated regression
Compliance Factory
- SOPs, change control & CAPA
- Deviation handling and closure
- Mock inspections and vendor qualifications
- SDLC documentation & AMS Compliance
Advisory & Strategy
- CSV- CSA Transition frameworks & roadmap design
- Global process harmonization of Validation processes
- Consulting for regulatory office setup
Specialized CSV
- MES, SCADA, PLC, DCS & instrumentation
- Cleaning and sterilization IT Validation
- LIMS, CDS & analytical labs S/w CSV
- Packaging & serialization s/w CSV
Industries we empower
Pharma
Ensuring reliable drug development & manufacturing systems
Medical Devices
Validating safety & effectiveness across demographics
Biotech
Securing Compliance for advanced therapies & research
Empower Your Business to Lead the Future
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Explore our wide gamut of digital transformation capabilities and our work across industries
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