Delivering Audit-Ready Computer System Validation for Pharma & Life Sciences
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 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
Ten documented deliverables, assessment to release
Every artifact numbered, traceable and ready for inspection.
- 01
GxP Assessment
Identify which systems require validation and categorize them per GAMP 5.
- 02
Validation Plan
A detailed validation plan for the system.
- 03
System Requirement Specifications (SRS)
Documented requirements for the system.
- 04
Risk Assessment
Initial and functional risk assessment.
- 05
Installation Qualification (IQ)
Verify hardware and software components are installed correctly.
- 06
Operational Qualification (OQ)
Verify all functions operate correctly.
- 07
Performance Qualification (PQ)
Verify system performance under real conditions.
- 08
Validation Summary Report (VSR)
Summary report issued after all qualification runs.
- 09
Traceability Matrix
Traces all tests across qualification activities.
- 10
System Release Certificate
Issued after all tests pass successfully.
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.