Gap Analysis de Post-Market Surveillance (PMS)
When talking about Gap Analysis in medical devices, the conversation usually goes straight to the technical file, the QMS (Quality Management...
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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...
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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...
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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...
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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...
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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...
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New Annex 15 on the Horizon: What You Should Review Starting Now
The revision of EU GMP Annex 15 once again brings a critical issue to the forefront for the pharmaceutical industry: how to demonstrate that...
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Ambit Iberia Receives the Loyalty Partner Award from ManageEngine
At Ambit Iberia, we are proud to have received the Loyalty Award during the ManageEngine Partner Training 2026, an exclusive event for partners held...
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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...
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Ambit Meets 2026: Tech Trends & Compliance in Life Science
Professionals from leading companies across the Life Sciences sector gathered for a new edition of Ambit Meets: Tech trends & Compliance in Life...
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ITSM & ITOM Solutions: Strategy and Benefits to Drive Efficiency
In many organizations, the IT department has evolved beyond merely resolving incidents or maintaining operational systems. It is now expected to play...
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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...
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Partner Insights Magazine 2026: The Present and Future of Life Sciences
At Ambit Iberia, we believe that innovation reaches further when built on collaboration. That is why, once again this year, we are launching Partner...
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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...
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Does My Company Need Outsourcing or Can AI Handle It?
Outsourcing or artificial intelligence? Discover in this article when you need external talent, what AI can automate, and why more and more companies...
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