Regulatory Compliance

Building a Smarter Regulatory Future: Innovation, Access, and the Fight Against AMR

Leave a Comment / Blog, Conversations That Matters, Regulation / No deviation

Conversations That Matter No deviation’s Takeaways from 2025 ISPE Europe Annual Conference in London Speaker: Dr. Evdokia Korakianiti – Head of the Quality and Safety Department at the European Medicines Agency (EMA) At this year’s ISPE Europe Annual Meeting, Dr. Evdokia Korakianiti delivered a timely message: we are at a unique regulatory inflection point in Europe—one…

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Who Owns Compliance? Shared Responsibility in the SaaS Era

Leave a Comment / Blog, Conversations That Matters, Quality and Compliance / Julie Loison

Conversations That Matter No deviation’s Takeaways from ISPE France Conference – Evolution of Supplier Relationships in Regulated SaaS Environments Topic: A deep dive into how the supplier-client relationship is evolving in SaaS solutions for regulated industries like pharmaceuticals—focusing on the critical shift toward true partnership and shared responsibility. Speaker: Philippe Lenglet – Dassault Systèmes 3DS

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Revolutionizing Pharmaceutical Manufacturing: Robotics, Teleoperation, and Digital Twins

Leave a Comment / Blog, Digitalization / No deviation

Conversations That Matters No deviation’s Takeaways from ISPE Facilities of the Future Conference in San Fransisco Shanshan Liu, our technical director and Pierre Winnepenninckx, our CEO were attending ISPE Facilities of the Future conference 2025 happening last week! Here’s a summary of the sessions they attended on Robotics, teleoperation and ditigal twins. Introduction This content summarizes

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c and q lifecycle pharmaceutical industry no deviation

Defining Requirements in the C&Q Lifecycle

1 Comment / Blog / Nd Admin

The ISPE Baseline Guide Volume 5: Commissioning and Qualification Second Edition proposes an integrated C&Q approach that aims to make the C&Q process compliant, efficient, and cost-effective. The key facets of this approach are as follows: Using a System Risk Assessment (SRA) to identify Critical Design Elements (CDEs) that need to be qualified Using properly

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Building a Smarter Regulatory Future: Innovation, Access, and the Fight Against AMR

Who Owns Compliance? Shared Responsibility in the SaaS Era

Revolutionizing Pharmaceutical Manufacturing: Robotics, Teleoperation, and Digital Twins

Defining Requirements in the C&Q Lifecycle

Revolutionizing Validation Processes: VEQTOR’s Out-of-the-Box Solution for Dechra Pharmaceutical PLC

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