Regulated Environment
What are the essential ISO standards in the healthcare sector?
In a sector as regulated as healthcare, complying with international quality and safety standards is not optional: it is a necessity. ISO standards...
From ticket to root cause: how to connect ITSM and ITOM to reduce resolution times
When a user opens a ticket because an application is not responding, the problem may have started much earlier.
In this article, we analyze how the...
Ambit Iberia and Applus+ Laboratories join forces to drive innovation in Life Sciences
“The collaboration combines Ambit Iberia's experience in specialized consulting for Life Sciences with the technical and regulatory capacity of...
Expert guidance as a key factor in the medical device lifecycle
The success of a medical device does not depend solely on its technological innovation, but on how its regulatory and quality compliance is managed...
Is Your IT Infrastructure Really Prepared? The Importance of Qualification in Regulated Environments
Equipment Qualification in Vaccine Production Under Annex 1
Vaccine manufacturing takes place in one of the most demanding environments in the pharmaceutical industry. The need to guarantee sterility, product...
Endpoint Management (UEM): What It Is and How to Unify IT and Security
The way companies manage their corporate devices has changed radically in recent years. Hybrid work, enterprise mobility, and the massive adoption of...
Ambit Iberia and Andersen Join Forces to Boost Their Global Capabilities
In a sector as demanding and highly regulated as Life Sciences, collaboration is key to driving innovation without losing sight of regulatory...
CER: The Cornerstone of Clinical Evaluation for Medical Devices
Clinical evaluation is no longer merely a regulatory requirement to obtain a CE mark: it is the defining factor for the credibility and market...
Turn Your QMS into a Competitive Advantage
In the Life Sciences sector—particularly across Medical Devices, Pharma, and Biotech—a Quality Management System (QMS) is often perceived strictly as...
ISPE Europe Annual Conference 2026: Core Foundations of Data Integrity
Participating in the ISPE Europe Annual Conference 2026 was a great opportunity not only to share our experience implementing a Data Integrity...
Clean & Black Utilities in Pharma: Differences for Your GMP Control
In a pharmaceutical manufacturing plant, not everything that sustains production is visible at first glance. Behind every process, auxiliary systems...
How to adapt to regulatory changes in the medical devices sector
The regulatory environment for medical devices is constantly evolving. New regulations, guidelines, standards, and updates from competent authorities...
AI in GxP Environments: The Questions We Can No Longer Put Off
Over the past few years, Artificial Intelligence has moved from being an emerging technology to becoming an increasingly tangible reality in the Life...
Ambit Iberia and The Triality Group announce Partnership to accelerate Trusted Artificial Intelligence in Life Sciences
Ambit Iberia, a leading Life Sciences consultancy specializing in Pharma & Biotech, Digital Solutions, and Medical Devices, is proud to announce a...