Qualify IT Solutions
Quality. Compliance.
Innovation.
Your partner in the expert delivery of world-class pharmaceutical facilities — from concept to operation. We bring CSV, CQV and GxP expertise with local support and global reach.
A fresh approach to
pharma validation.
- Expert CSV & CQV engineers with proven delivery
- Local support backed by global subject-matter expertise
- Cost-effective designs that meet regulatory requirements
- Complete lifecycle support from concept to operation
Computer System Validation (CSV)
Comprehensive CSV services ensuring accuracy, reliability and compliance with electronic reco....
21 CFR Part 11 Compliance
GAMP 5 guidelines and risk-based validation to deliver inspection-ready electronic...
Commissioning & Qualification (CQV)
Expert CQV services for pharmaceutical facilities — from concept and design to opera...
Excel Sheet Validation
Critical spreadsheet validation ensuring accuracy, reliability and regulatory compliance for....
Our expert services
Comprehensive validation and engineering services for pharmaceutical, biotechnology and software industries — with local support and global expertise.
Computer System Validation (CSV)
Comprehensive CSV services ensuring accuracy, reliability and compliance with electronic record standards across pharmaceutical systems.
21 CFR Part 11 Compliance
GAMP 5 guidelines and risk-based validation to deliver inspection-ready electronic records and signatures.
21 CFR Part 11 Compliance
GAMP 5 guidelines and risk-based validation to deliver inspection-ready electronic records and signatures.
Excel Sheet Validation
Comprehensive CSVCritical spreadsheet validation ensuring accuracy, reliability and regulatory compliance for pharmaceutical calculations
Pharmaceutical Training
Comprehensive training programs covering GMP, regulatory compliance, quality management and data integrity.
Kośa GxP Software
Validated DMS & LMS with ALCOA++, 21 CFR Part 11 e-signatures and tamper-evident archiving.
Why choose Qualify
IT
Solutions?
Expert CSV & CQV Engineers
Seasoned engineers with a proven track record across regulated facilities.
Local Support, Global Expertise
On-the-ground delivery backed by global subject-matter expertise.
Cost-Effective Solutions
Right-sized designs that meet stringent regulatory requirements without overspend.
Complete Lifecycle Support
Concept, design, commissioning, qualification and post-handover aftercare.
GxP & Non-GxP Systems
Specialised across GxP and Non-GxP systems, instruments and infrastructure.
Training & Documentation
Comprehensive training and inspection-ready documentation packages.
Trusted across
regulated
sectors.
Our validation, qualification and GxP software expertise spans the full life-sciences value chain.
Pharmaceuticals
Formulations, OSD, sterile & API plants.
Biotechnology
Vaccines, biologics & cell therapy.
Life Sciences
R&D, QC labs & analytical systems.
Medical Devices
Class I–III device manufacturing.
Consumer & Nutra
Nutraceuticals & FMCG manufacturing.
Agro & Food
Agrochem, food safety & cold chain.
Insights from our
compliance experts.
Brochures, whitepapers and articles to help your team stay inspection-ready.
Brochure
QIS Professional Services Brochure
Complete overview of CSV, CQV, Thermal Validation, HVAC and Audit services.
Flyer
Kośa DMS & LMS — GxP Software Suite
Whitepaper
GAMP 5 in Practice
Trusted by quality leaders
across life sciences.
What pharma, biotech and medical-device teams say about working with Qualify IT Solutions.
Partnering with leading life-sciences organizations
Zydus
Ready to qualify your facility?
tailored proposal within 48 hours.