DAC INFO is a premier technology and engineering service provider delivering a wide range of computerized system validation, automated systems integration, and specialized compliance consulting to the Life Sciences industry. We support highly regulated verticals including pharmaceuticals, biotechnology, medical equipment manufacturing, and genetics research, ensuring your systems are secure, efficient, and fully compliant.
To support your global market expansion, our dedicated EU GMP Consultancy division provides complete, end-to-end guidance for obtaining EU-GMP certification. From raw layout and system gap audits to pre-inspection CAPA planning, QMS updates, and regulatory dossier execution, we prepare OSD, injectable, and biosimilar manufacturing facilities for flawless regulatory inspection.
Adequate compliance protocols are imperative to align with standard global quality frameworks. We provide authoritative data integrity and upgrade execution in the areas of SAP/ERP validation, PLC validation, Excel spreadsheet validation, and comprehensive IT infrastructure qualification.
Our systems are dedicated to implementing the concepts for Computer System Validation as per Good Automated Manufacturing Practices and helping companies address the requirements of GAMP 5, Annex 11, and 21 CFR Part 11 Electronic Records and Electronic Signatures.
