CSV Reinvented | Coforge

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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)	Compliance Factory
IQ/OQ/PQ authoring & execution Cloud Validation Agile Validation-CI/CD/CT integration with automated regression	SOPs, change control & CAPA Deviation handling and closure Mock inspections and vendor qualifications SDLC documentation & AMS Compliance

Advisory & Strategy	Specialized CSV
CSV- CSA Transition frameworks & roadmap design Global process harmonization of Validation processes Consulting for regulatory office setup	MES, SCADA, PLC, DCS & instrumentation Cleaning and sterilization IT Validation LIMS, CDS & analytical labs S/w CSV Packaging & serialization s/w CSV

AI accelerators

Our digital toolkit brings speed, accuracy, and intelligence to CSV:

CS governance, risk & compliance HB 1 - Information Security Assessment

AI-driven risk assessment & RTM

Frameworks-Accelerators

BlueSwan accelerators for automated IQ/OQ/PQ

Unifying-Master-Data-Architecture-1

GDP reviewer bots to slash documentation errors

Risk-Based

Audit dashboards for instant readiness checks