globenewswire news
Devia Emerges from Stealth with an Agentic AI for GxP Pharma Quality Management
After a year of building with manufacturing and quality teams, Devia spins out of Visium and is now available to the world’s largest biopharma companies, CDMOs and CROs, so every deviation gets solved once, not closed twice.
Zurich, Switzerland, Nov. 11, 2026 (GLOBE NEWSWIRE) -- Devia is an agentic AI that works every stage of a GxP deviation, from first report on the shop floor to root cause, CAPA and an inspection-ready closure. It emerged from stealth today after a year in pilot with quality teams in live GxP environments.
From pharma expertise to an industry product
Devia grew out of Visium’s work with pharmaceutical manufacturers, where the same pattern appeared every time: deviation investigations were slow, manual and inconsistent from site to site. A pilot with one of the world’s largest CDMOs confirmed it, and showed how much faster investigations could run with an agent doing the legwork. To turn that work into a product for the whole industry, Visium set up a dedicated leadership team: Andrea Tassistro (former CTrO at Owkin), Anton Van Pamel (former Partner at BCG X) and Pascal Rodriguez (former Head of Engineering at Bestmile). Over the past year, the team rebuilt the solution as a scalable, multi-site platform and tested it with quality teams in live GxP environments, shaping the roadmap around their feedback.
Investigations under pressure, and AI under a new EU standard
Regulators expect manufacturers and their partners to show thorough, timely and well-documented investigations across every site. For most quality organizations, that is hard to do with today’s tools. At most sites, deviation work is still largely manual: reports arrive late and incomplete, investigators chase context across several systems, and deadlines leave little time to find the real root cause. Inadequate investigations are among the most frequent inspection findings in the industry, and the same problem often recurs, sometimes at another site.
At the same time, quality teams now have to answer for any AI they bring into a GxP process. The EU AI Act sets the bar for how providers of high-risk AI must manage quality, and in October 2026 the European Commission published EN 18286, the first harmonised standard under the Act, which describes the quality management system expected of them. Devia is designed in line with those principles: every AI suggestion is traceable, and the record shows what the AI proposed, what the qualified reviewer decided, and why.
“Every quality leader knows the moment: a deviation lands that looks familiar, and nobody saw it coming. We sometimes fail to connect the dots and see the bigger picture that reveals recurring deviations. Devia connects them, so the real cause is found the first time and a repeat is caught before an inspector does,” said Anton Van Pamel, CPO, Devia.
An agent for the whole deviation lifecycle
Devia’s agent handles the heavy work across every stage: it structures the event at intake, pulls the evidence together, proposes the root causes and drafts the CAPA. Operators, investigators and QA stay in control, reviewing and approving every step on a complete, inspection-ready record. Devia checks each root cause against past cases to flag recurrences, and its trend monitoring shows when the same theme appears across sites.
Built for GxP, designed to fit existing systems
Devia works with the validated systems customers already run, such as TrackWise, Veeva Vault QMS and MasterControl. Every AI suggestion is traceable, and a qualified reviewer makes and signs every decision, as GxP requires. In customer pilots, Devia has halved the time users spend investigating deviations.
Built for biopharma, CDMOs and CROs
Devia is designed for organizations that run many sites and many partners. Large biopharma companies use it to standardize investigations across their network. CDMOs use it to close deviations faster for multiple sponsors, each with its own requirements. CROs use it to keep GxP records complete and audit-ready across studies.
“For a year we built Devia quietly, side by side with the people who live with deviations every day,” said Pascal Rodriguez, CTO, Devia. “Quality teams don’t need another system of record. They need an agent that does the groundwork, so their experts can focus on the root causes that matter.”
Press kit available → here
About Devia
Devia exists to get safe, effective medicines to patients. It helps biopharma companies, CDMOs and CROs capture, investigate and resolve deviations quickly, turning quality events into insight that keeps therapies safe and on time. Devia is a Visium spin-out based in Zurich. For more information, visit www.devia.qa
CONTACT: Andrea Tassistro, CRO, Devia andrea.tassistro@visium.com Pascal Rodriguez, CTO, Devia pascal.rodriguez@visium.com Anton Van Pamel, CPO, Devia anton.vanpamel@visium.com Erica Zeidenberg, PR for Devia erica@hottomato.net
