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CSV · CQV · GxP Compliance

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.

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Our Expert Services
ISO 9001
2015 Certified
50+
Projects deleivered
GxP
Compliance focus
24/7
Expert support
who we are

A fresh approach to pharma validation.

Qualify IT Solutions is a startup engineering & design partner bringing fresh perspectives and innovative solutions to traditional pharmaceutical validation challenges — across pharmaceutical, biotechnology and software industries.
  • 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
Learn more about us

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....

What we do

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 us

Why choose Qualify
IT Solutions?

As a startup in engineering & design, we bring fresh perspectives and innovative solutions to traditional pharmaceutical validation challenges.

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.