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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.

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.

industries we serve

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.

resources

Insights from our
compliance experts.

Brochures, whitepapers and articles to help your team stay inspection-ready.

View all Resources

Brochure

QIS Professional Services Brochure

Complete overview of CSV, CQV, Thermal Validation, HVAC and Audit services.

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Flyer

Kośa DMS & LMS — GxP Software Suite

GxP-compliant Document & Learning Management for life sciences.
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Whitepaper

GAMP 5 in Practice

A practical guide to applying GAMP 5 to legacy and modern computerised systems.
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testimonials

Trusted by quality leaders
across life sciences.

What pharma, biotech and medical-device teams say about working with Qualify IT Solutions.

“Their CSV team navigated our EU Annex 11 audit flawlessly. Documentation was inspection-ready from day one.”

Dr. Anita Rao
Head of QA, Sterile Manufacturing
Global Pharma Co.
“Thermal validation of our lyophilizer and depyrogenation tunnel was completed ahead of schedule with zero deviations.”
Rajesh Menon
Validation Lead
Biotech Innovators
“The Kośa DMS rollout transformed our document control. ALCOA++ compliance has never been easier to demonstrate.”
Sandra Lewis
Director, Quality Systems
MedDevice Solutions

“QIS Services delivers professional, reliable, and quality-driven validation and compliance solutions. Their team demonstrates strong technical expertise, excellent support, and a clear understanding of pharmaceutical industry requirements. Highly recommended for CSV, qualification, validation, and GxP compliance services.”

GV Srinivas
Head of Quality Assurance
Eris Bionex

“I am pleased to share that I have had a positive experience with Qualify IT Solutions’ services, particularly in the areas of validation and qualification of premises and computer system validation. Your team’s expertise and professionalism were evident throughout the process, and I am confident in the results.
I appreciate your commitment to ensuring customer satisfaction and would not hesitate to recommend your services to others.“

Naveen Ramagiri
QA Manager & QP
Interchemie Werken De Adelaar, Estonia

“We had a great experience with Qualify IT Solutions for our Computer System Validation (CSV) activities. The team was knowledgeable, professional, and responsive throughout the engagement. Their understanding of GxP requirements and validation practices was impressive, and they delivered the required support effectively“

Sheik Ahmed
Asst Manager – Quality
Bharat Biotech International Limited

“Qualify IT Solutions has been a reliable partner for our validation and compliance requirements. Their team combines technical expertise with a practical understanding of pharmaceutical industry expectations. The overall engagement was smooth, professional, and well managed. We confidently recommend QIS for CSV and qualification services.“

Shimhachala Naidu
Deputy Manager
Lazuline Biotech Private Limited

“We appreciate the excellent support provided by Qualify IT Solutions for our qualification and validation activities. Their technical team was knowledgeable, cooperative, and responsive to our requirements. Their professional execution and commitment to quality made the overall experience very positive“

Bakkireddy Ravindra Reddy
Sr.Manager
GCBC Private Limited
our clients

Trusted by leading pharma &
biotech innovators

From vaccine pioneers to specialty pharma, our clients rely on us for CSV,
CQV and GxP excellence.

GCBC Vaccines Pvt. Ltd.

  • Medchal, Hyderabad
  • Muppireddy Pally, Hyderabad

Virchow Biotech Pvt. Ltd.

  • Unit-1, Gagillapur
  • Unit-2, Gagillapur
  • Unit-4, Kajipally
  • Unit-5, Sultanpur

Bharat Biotech International Ltd.

  • Turkapally, Hyderabad

Aspiro Pharma Specialities Pvt. Ltd.

  • Karkapatla, Hyderabad

Ichor Biologics Pvt. Ltd.

  • Turkapally, Hyderabad

Bilas Veteran

  • Uppal, Hyderabad

Jeevan Scientific Technology Ltd.

  • Manikonda, Hyderabad

Kshirsa Bio-Pharma Pvt. Ltd.

  • Turkapally, Hyderabad

Eris

  • Ahmedabad, Gujarat

Axygen Pharmatech

  • Hitech City Hyderabad

Levim Lifetech Pvt Ltd

  • Taramani, Chennai
  • 9+ enterprise clients
  • 15+ facilities served
  • Pan-India presence

Ready to qualify your facility?

Talk to our CSV & CQV experts about your next pharma project — get a tailored proposal within 48 hours.

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