Quality Management Systems & Certifications
We help out customers meet regulatory compliances with ease. Our products have measures to address quality and regulatory requirements built inherently in them. This makes companies audit-ready and achieves compliance without compromise.
At Agaram Technologies, quality & customer satisfaction is not just a top priority, but a part of our DNA.
We support our clientele in meeting their goals by conceptualizing, customising, designing and delivering products that suit their day-to-day operational requirements. Two decades of legacy in serving the crème de la crème has helped us learn the intricacies of several industries.
Our products and solutions have helped our customers meet cGMP, Data Integrity, GxP, Regulatory Compliance such as US FDA, 21 CFR Part 11, EudraLex annex 11, ISO 17025 and other industry standards.
ISO 9001:2015
Agaram Technologies is an ISO 9001:2015 certified organisation and was awarded the certification after being assessed by TUV SUD South Asia Private Limited, a leading technical service organisation.
ISO 9001:2015 is the International Quality System Standard accepted worldwide. It ensures all quality-related activities in an organization are adhered to ensure that the customers’ expectations are met. The ISO 9001:2015 certification is conferred by independent, accredited third parties to certify that the organization's quality management system conforms to the requirements of the standards.
21 CFR Part 11
21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States FDA regulations on electronic records and electronic signatures. It explains how a company can use electronic quality records and digital signatures in place of paper-based documentation and ‘wet signatures’ in such a way that complies with FDA regulations.
Logilab ELN, along with all our other solutions, are 21 CFR Part 11 compliant. With features such as Controlled roles and rights-based user access to data, time-stamped audit trails and e-signatures, secure storage of data in a dedicated Azure server, and fully built-in indexing and search functionality for data, your data security and traceability are never in doubt.
Quality Policy
Agaram Technologies strives to deliver innovative laboratory information software solutions and services that meet & exceed customers’ requirements in terms of quality, value and compliance. We are committed to achieving continuous improvement & compliance with quality management system standards and processes through periodic reviews of its effectiveness.
