At Sofgen Infotech Private Ltd, quality and security are at the heart of everything we do. We are proud to be an ISO-certified company, demonstrating our commitment to delivering reliable, secure, and high-quality solutions to our clients.

We hold the following internationally recognized certifications:

ISO 9001:2015 – Quality Management System
This certification reflects our dedication to consistent quality, customer satisfaction, and continual improvement in all our services and processes.

ISO/IEC 27001:2022 – Information Security Management System
This certification ensures that we follow best practices in protecting sensitive data, managing information security risks, and maintaining confidentiality, integrity, and availability of information.

FDA 21 CFR Part 11 Compliance – Electronic Records & Electronic Signatures
This compliance demonstrates our ability to support systems that meet the requirements of FDA 21 CFR Part 11 for electronic records and electronic signatures. It reflects our commitment to data integrity, audit trails, system validation, user authentication, and secure record management for regulated industries such as pharmaceuticals, biotechnology, healthcare, and life sciences.

GxP Compliance – Good Practice Compliance Standards
Our GxP-compliant solutions are designed to help organizations maintain quality, safety, and regulatory compliance across their operations. This compliance reflects our commitment to supporting validated processes, accurate documentation, data integrity, risk management, and quality assurance requirements within regulated industries.

These certifications validate our efforts to maintain the highest standards of operational excellence and information security, helping us build long-term trust with our clients and partners.