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I'm excited to be presenting at the 2025 SQA Annual Meeting next week - "Is it the Right Tool for the Job? How QA and Regulatory Professionals can Guide Software Decisions in Regulated Environments" As our familiar software tools become more feature-laden and generalized, it's critical to ensure that software meets clear use cases and basic user requirements. And with generative AI being shoehorned into every platform, defining if and how software is appropriate for the intended use has never been more important. – Brendan p.s. Enjoy this message? Read more at the Hyland Quality Systems website. |
I'm Brendan Hyland. I help regulated facilities transform their software, spreadsheets, workflows and documents from time-consuming, deviation-invoking, regulatory burdens, to the competitive advantage they were meant to be. Join me every week as we take a few minutes to explore, design, test and improve the critical systems we use in our facilities.
I’ve seen this pattern repeatedly: Instrument data is saved as an Excel or CSV. Data is then copied to a bare-bones spreadsheet with several columns of calculations or transformations. Results from the spreadsheet’s calculations are copied for use further down the data analysis pipeline. And I, the auditor, get handed a signed and dated pdf of the worksheet. Was this email forwarded to you? Subscribe Here! Why yes, M. Inspector, this spreadsheet was validated! Ok, they are rarely this bad - I...
Calling quality people everywhere! I've just released something I think you'll find useful. Over the past 20 years working in regulated environments, I've seen the same spreadsheet problems show up again and again: A quick Excel tool gets built to solve an immediate need. It works. Gets "validated" with a few hand calculations. Then gets reused and modified for different datasets or slightly different purposes. Eventually - sometimes months or years later - someone discovers an error. Or an...
I'm thrilled to announce that I'll be presenting at the CCSQA/NERCSQA Joint Annual Meeting in October! The conference is 2 days, Thursday & Friday, 16-17 October 2025, in Laval, Quebec, Canada. On-site and virtual attendance available. Here's the announcement link: https://sqa.org/CCSQA/CCSQA/Events/Upcoming_Events.aspx My session is on Friday morning, and titled "The power of a specification: Freeing your creative self to go beyond compliance." Here's the abstract: As busy quality...