Pharmaceutical and life sciences companies operate under the most stringent regulatory environments in the world. Sumato builds validated, compliant software systems engineered to satisfy FDA,EU, and ICH requirements from day one.
Validated SDLC
Sumato builds validated software systems for pharmaceutical, biotech, and medical device companies — from drug supply chain traceability to clinical data management and regulatory submissions.
Every system we deliver is engineered to meet FDA 21 CFR Part 11, EU Annex 11, GMP, GCP, and GAMP 5 requirements with full documentation packages.
Modern pharma systems must satisfy layered regulatory requirements simultaneously. Compliance is an architecture decision that must be made before the first line of code.
Electronic records & e-signatures
Computerized systems in pharma
Manufacturing & clinical practice
Risk-based validation approach
Pharmaceutical quality systems
Every system Sumato delivers follows a documented GAMP 5-compliant validation lifecycle — from User Requirements Specification through Installation,Operational, and Performance Qualification.
Full URS, FS, IQ, OQ, PQ documentation delivered with every validated system
Complete audit trail and electronic signature capabilities built in from architecture stage
Test scripts, test results, deviation reports, and validation summary reports ready for inspection
Sumato Solutions serves 11 primary industries: Real Estate, Ecommerce, Education, HR/Recruitment, Retail, Hospitality, Transportation & Logistics, Insurance, Digital Wallets & Fintech, Entertainment & Media, and Pharmaceutical. Additionally, we have delivered solutions for clients in manufacturing, healthcare, construction, NGO, and finance through our Sumato ERP product line, which covers 12 industry verticals.
Sumato Solutions helps businesses at every stage, offering custom software to build strong foundations, smart marketing strategies to grow, and AI-powered tools to automate operations that make business processes simpler, faster, and more effective.
Sumato Solutions helps businesses at every stage, offering custom software to build strong foundations, smart marketing strategies to grow, and AI-powered tools to automate operations that make business processes simpler, faster, and more effective.
Sumato Solutions helps businesses at every stage, offering custom software to build strong foundations, smart marketing strategies to grow, and AI-powered tools to automate operations that make business processes simpler, faster, and more effective.
Build validated, compliant, and secure pharma software solutions
with Sumato Solutions.
