Your Systems.
Our Validation Expertise.
Complete Compliance.
We ensure compliance with GxP, 21 CFR Part 11, and GAMP 5 through validated process control, laboratory, and enterprise systems — with complete, inspection-ready documentation.
Regulatory CSV & Software Services
GxP & Pharma Software Solutions
Turnkey, pre-validated software products built for 21 CFR Part 11, EU Annex 11, and ALCOA+ compliance.
eQMS — Electronic Quality Management System
Automated Deviation, CAPA, Change Control, and Market Complaints workflows.
- Deviation & Incident Management with root-cause analysis tools
- Automated CAPA workflows with effectiveness review tracking
- Change Control with cross-departmental impact assessment
eDMS — Electronic Document Management System
SOP lifecycle, controlled distribution, and electronic signature workflows.
- Automated SOP lifecycle with multi-level review and approval
- Role-based electronic signatures (dual authentication)
- Dynamic watermarking for controlled viewing and printing
LMS — GxP Learning & Training Management
Automated role-based training matrices and SOP revision retraining.
- Dynamic training matrices mapped to job roles and departments
- Automated retraining triggers when SOPs are revised in eDMS
- Online assessments, timed quizzes, and automated scoring
Computerized System Validation Framework
Core regulatory standards and principles ensuring end-to-end GxP compliance, accuracy, and inspection readiness throughout the computerized system life cycle.
Computerized system validation framework to achieve and maintain GxP compliance throughout the computerized system life cycle.
Validation plans and reports provide a disciplined and consistent approach to meeting regulatory requirements.
Validation of systems to ensure accuracy, reliability, and the ability to discern invalid or altered records.(Ref.: 21 CFR 11.10 (a))
A computerized system includes hardware, software, network components, and controlled functions.(Ref.: ISPE GAMP5)
A focused CSV & compliance partner
We provide Computer System Validation (CSV) and compliance services for pharma & life sciences companies. With expertise in GAMP 5, 21 CFR Part 11, and EU Annex 11, we help clients stay audit-ready.
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Expert Validation Team
Fully focused on CSV, GxP compliance and pharma regulations.
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Audit-Ready Documentation
Documentation and systems that pass inspections confidently.
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Customized Approach
Validation strategies tailored to each client's needs.
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End-to-End Compliance Support
From gap analysis to training, covering every stage.
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Trusted Partner
Working with companies who prioritize quality and patient safety.
Our validation practice is built on these regulatory frameworks. ISO 9001:2015 is listed as a quality management framework we work to; certification status will be confirmed and displayed once verified.
Get a Free Consultation
Tell us about your systems. We will map them to GAMP 5 and outline the path to an audit-ready state — at no cost.