ISPE Boston Product Show 2025 Recap

Introduction

The International Society of Pharmaceutical Engineering Boston Chapter puts on one of the most well-attended one-day shows in the industry. This show is truly unique, from the venue of Gillette Stadium to the one-day format, and most importantly, thanks to the amazing camaraderie and attendance of the life science community in and around New England.

GKS Team Booth

We were proud to exhibit and showcase the Global Key Solutions (GKS) product suite at this year's show. Our team had incredible conversations and demos at Booth E34, showing how GKS is bringing quality to the forefront with unprecedented AI tooling.

Key Takeaways from Attended Talks: CSA, Cloud Audits, and the Future of Quality

The educational sessions, some of which were hosted by Boston-based Communities of Practice (COPs), provided a great level of detail and insight. A major topic was the FDA's new guidance on Computer Software Assurance (CSA). Here, discussion was had around how the new guidance is giving our industry better clarity into software vendors, and how to define, audit, and work with them.

One session, attended by George Kwiecinski and Kasia Grzelecka, was The GAMP COP session, "Do Vendor Audits & Quality Agreements Matter in a Cloud-Oriented GxP Environment?" was particularly insightful. Key takeaways included:

• The Audit Paradigm Shift: "The way we approached audits 10 years ago is different." With the move from on-premise servers to multi-layered SaaS and cloud vendors (like AWS), the old methods of walking into a server room are obsolete.
• Beyond the Certificate: While certifications like SOC 2 and ISO 27001 are important, they can't be blanketly accepted for GxP compliance. It's crucial to partner with vendors who have a deep regulatory understanding.
• CSA in Practice: The CSA guidance's risk-based approach (low-risk for out-of-the-box vs. high-risk for custom) is changing how the industry validates software and manages vendors.
• Data is King: The discussion repeatedly returned to the importance of data governance, disaster recovery planning, and ensuring you have a plan for your data if you part ways with a vendor. Having a "right to audit" clause is more important than ever.

Global Key Solutions Updates

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Keep in Touch with GKS

We look forward to the upcoming ISPE Annual Conference. Follow us to keep updated! To learn more about how GKS is building to solve these challenges, or for general inquiries and features, please contact: hello@globalkeysolutions.net