This is your STEMSOFT quarterly update, informing you of important changes to your software, innovations in the industry, and upcoming events. Please be sure to login to STEMSOFT’s Support Website first in order to access the full articles, supporting documents, and release notes linked in this email.

A Message from our Managing Director: I’m shocked that it is already summer here in Vancouver. As many of you know, it has been a difficult spring and summer in Canada, with both wildfires and flooding affecting most provinces. While my thoughts are with those that have been directly affected, I’m also encouraged that STEMSOFT, as part of STEMCELL Technologies Canada, passed our most recent Environmental Management (ISO 14001) and Quality Management (ISO 9001) audits, ensuring that we are taking every step necessary to reduce our carbon footprint and other environmental impacts.

I firmly believe that public standards are one of the most effective ways that STEMSOFT can help you achieve your goals. Specifically, HL7® FHIR® (Fast Healthcare Interoperability Resources) and the Biologically Derived Product concept. I wrote about Biologically Derived Product in our last newsletter and it continues to be the first and only standard way to communicate cell-based product data with partners like Epic or commercial cell product manufacturers.

On a happier note, we released a new generally available version of STEMSOFT CLINIC this quarter. STEMSOFT CLINIC now supports additional workflow types that make iteasier to document your patients’ journeys while also supporting more consistent and timely data entry. Keep an eye out for our forthcoming general release of STEMSOFT LAB with even more new and improved features.

STEMSOFT returned to the International Society for Cell & Gene Therapy (ISCT) annual meeting for the first time in five years. It was exciting to meet several of you in person and to speak with commercial, clinical, and academic cell therapy vendors about the state of digitalization in our subspecialty. I want to specifically call out the ICCBBA efforts to promote adoption of the MPHO unique identifier which I believe will significantly improve communication between all classes of manufacturer.

I continue to be optimistic and excited to support you and your work. I was privileged to participate in a University College London study on digitalisation and automation in the development, manufacture, and delivery of cell and gene therapies earlier this quarter and came away with the view that facilitating traceability and information exchange for medical products of human origin can have a real and dramatic effect on patient outcomes. I look forward to continuing the journey with you.

Geoff

	NEW versions of STEMSOFT are available! STEMSOFT has released a new version of our CLINIC application v1.0.25733.0, with LAB and CORD GA Releases on the horizon. The latest CLINIC release has been updated to add support for ASTCT RFI 2023, including revisions to form mappings to populate additional data prepare a baseline dataset for further data entry and validation by data management staff. In CLINIC there are also new workflow action types that allow selection of Protocols and Diagnosis records within a workflow. If you have not had the opportunity to review STEMSOFT CLINIC Workflows, be sure to contact your implementer to schedule a walk-through of existing workflows that you can add to your configuration. Contact Support to schedule your upgrade. View updated CLINIC Release Notes.

Completed and Upcoming Webinars and Micro Tutorials: In June STEMSOFT completed the Remote Vendor Audit Webinar. Every two years we complete a Vendor Questionnaire document live covering the most commonly asked questions during a qualification audit. You can view the webinar here along with downloading the completed form and file it in your Document Control System to prove that you have evidence that your vendor is qualified to provide software for your use. If you have a proprietary Vendor Qualification form and you need more answers, please forward your form to STEMSOFT and we will complete it for your records. Join us for the next edition of our 200-series webinars that are designed to help you get more out of your STEMSOFT databases: Updated AABB Standards and Downstream Effects on STEMSOFT: In late August STEMSOFT will be recording and posting to our Support Portal an overview of the latest AABB Standards and what it means for STEMSOFT and your Application.

New Supporting Documents Available: STEMSOFT has been working hard to add to our Supporting Documents library and are happy to add: A new SOP to help guide you through the process of using the Configuration Management tool to import certain kinds of configuration into your Test and Production environments without needing STEMSOFT or IT for that deployment. We also have a form here to help you document the import and whether it is successful or not. Updated Label Printer Setup Instructions, Data Entry Tips and Tricks, and more! Important to note that we have updated all Configuration Verification forms that you use to verify your configuration change requests. All forms now have the STEMSOFT Countersign Block and will be reviewed by a member of the Customer Success Team. A signed copy will be returned to you via ShareFile. Please plan to download fresh forms after August 1st as our policies mandate that we use the most recent version and we will be returning them to you if they are not the latest version.

Congratulations! A big congratulations to all the clients that have gone live with STEMSOFT over these past months – great work!