Customized software & Validation services
In-person or Remote | Fully Compliant with GAMP5 and Global Guidelines
Trusted Validation Experts
We are a team of validation experts helping pharma, biotech, and regulated industries achieve audit-ready compliance. Our deep understanding of regulatory requirements ensures your systems meet the highest standards.
Decade of Excellence
Trusted by leading pharmaceutical companies worldwide
Our Validation Services
Comprehensive computer system validation services tailored to your industry needs
Validation Services
Standalone, Server based, PLC, HMI, DCS systems validation ensuring full regulatory alignment.
Risk Assessment
Comprehensive risk evaluation and mitigation strategies using GAMP5 and FMEA methodologies.
Customized Softwares
Ready-to-deploy solutions including EDMS, EQMS, Training (LMS), LIMS, and Attendance Payroll.
Compliance Services
21 CFR compliance, Site Wide GAP assessments, and professional SOP preparation.
Software/ERP Validation
End-to-end validation of software systems including ERP, LIMS, and manufacturing execution systems.
Data Integrity Assessments
Thorough evaluation of data integrity controls and ALCOA+ principles implementation.
Installation & Operational Qualification
Complete IQ/OQ protocols ensuring your systems meet specified requirements and operate correctly.
Audit Preparation
Complete audit readiness support including documentation review and mock audits.
Remote & On-site Engagement
Flexible service delivery options to meet your timeline and budget requirements.
Why Choose PharmaEddge?
We bring unmatched expertise and flexibility to every validation project
Decade of Experience
Over 10 years of specialized expertise in computer system validation across regulated industries.
Remote or On-site Validation
Flexible engagement models to suit your operational needs and geographical requirements.
Tailored Solutions
Customized validation approaches based on your specific systems, scale, and regulatory requirements.
Always Audit-Ready
Documentation and processes designed to withstand the most rigorous regulatory scrutiny.
Affordable Packages
Cost-effective validation solutions that deliver maximum value without compromising quality.
Global Compliance
Deep knowledge of FDA, EMA, and other international regulatory requirements.
Get In Touch
Ready to ensure your systems are validation-ready? Contact us for a free consultation.