Compligen

cGen AI-native GxP suite by compligen

SaaS

The moment I knew I had to build this I've spent more than three decades walking into companies — from global pharmaceutical, medical device, cosmetic, food, dietary supplement, tobacco, CRO, and CDMO giants to countless pre-revenue startups — and every single one had the same problem. Validation was trapped in endless versions of Word documents and Excel spreadsheets, tools that were designed for a different era, costing these FDA-regulated industries millions. My experience spans a broad range of GxP application systems, including but not limited to: ERP and MRP systems, SAP, Oracle, QMS, LMS, LIMS, MES, WMS, clinical and pre-clinical systems, document management systems, cloud-based applications, SaaS solutions, and automated manufacturing technologies. At Sanofi, I led a team of 16 across the US and Germany. At Abbott, I harmonized their validation lifecycle after a major acquisition of St. Jude Medical. At Takeda, Blueprint Medicines, and DP Clinical — the story repeated: brilliant QA and validation teams, drowning in manual work, resulting in extended timelines and exorbitant costs to bring their GxP systems into a validated state. I've been heavily involved in the industry's transition from the traditional, documentation-heavy CSV approach toward the FDA's modern Computer Software Assurance framework. While providing guidance, feedback, and critical-thinking expertise throughout the FDA's CSA Guidance development, I saw the industry at a crossroads. The regulations were evolving toward risk-based thinking and critical analysis — focusing on Patient Safety, Product Quality, and Data Integrity — and GAMP 4 and 5 standards lacked an adequately risk-based model. That's when I decided to create a solution and start building the cGen platform. cGen is the platform I wished existed across every one of those 100+ client engagements — designed to replace fragmented paper, spreadsheet, and hybrid validation processes with an integrated digital approach that aligns with the FDA's final Computer Software Assurance Guidance, published in February 2026.